1 FACULTY OF SPORT, EDUCATION AND SOCIAL STUDIES BA (Hons) Adventure Education 2015 I certify that the contents of this dissertation, which are not my own work, have been identified according to author and source. The influence of acute simulated high altitude on cognitive abilities and neurobiological functions By Max Burrows
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1
FACULTY OF SPORT, EDUCATION AND SOCIAL STUDIES
BA (Hons) Adventure Education
2015
I certify that the contents of this dissertation, which are not my own work, have been
identified according to author and source.
The influence of acute simulated high altitude on cognitive abilities and neurobiological
functions
By
Max Burrows
2
Acknowledgements
I would like to thank everyone who has helped me in completing this important piece of work.
Firstly, John Kelly, for all his advice and support throughout the dissertation process particularly in
the development of the research idea and testing procedure.
Secondly, to thank all participants who gave up their time to be involved in the research,
and to the people who assisted in the running of the testing procedure.
Finally, I would like to thank my parents for their continuous encouragement and for giving up
their time to proof read my work and assist me in its layout and formatting.
Thank you.
3
Abstract
Burrows, M. (2015). The influence of acute simulated altitude on cognitive abilities and
neurobiological functions. University of Chichester – Undergraduate Dissertation.
Keywords: Altitude, High Altitude, Hypoxia, Hypoxaemia, Cognitive Function, Blood Oxygen
Objective. To investigate the acute physiological and psychological responses to varying degrees of hypoxia, created by alterations in the inspired oxygen fraction (FIO2). Method. Eight healthy, male participants (19.4 ± 1.8 years) completed five exposures to a hypoxic environment: 20.3%, 14.5%, 13.5%, 12.7% and 11.9%. Measurements of heart rate (HR), arterial oxygen saturation (%,SpO2), Finger tapping test scores, Corsi block test scores and Eriksen Flanker task scores were recorded. Results. The reduction in FIO2 over the five conditions produced a decline in SpO2 (p<.0005) and a subsequent increase in HR (p= .032). There was a subtle decrease in Mean Finger Tapping Score however there was a large individual difference and the decrease was not seen to be significant. Corsi Block memory span remained uninhibited although, First Tap Latency (FTL) significantly increased (p= .024) over the five conditions. Mean Total Score oscillated with a decreasing FIO2. Congruent right and left hand response times were observed to be faster than incongruent responses times across the five conditions yet, response times decreased with a decrease in FIO2. Conclusion. The magnitude of the acute physiological response to hypoxia occurred relative to the reduction in FIO2. Neuromuscular control was witnessed to decrease as arterial SpO2 decreased however; the small sample size restricted it reaching a significant level. There were confounding results associated with cognitive function. It was demonstrated to decrease over the five conditions although; due to the psychological tests applied results may have been diluted compared to real life psychology stressors that could have been
Kessels, P., Zandvoort, M., Postma, A., Kappelle, L. & Haan, E. (2000). The Corsi Block-
Tapping Task: Standardization and Normative Data. Applied Neuropsychology.7(4). 252-258.
Kety, S. & Schmidt, F. (1948). The Effects of Altered Arterial Tensions of Carbon Dioxide and Oxygen on Cerebral Blood Flow and Cerebral Oxygen Consumption of Normal Young Men. Journal of Clinical Investigation. 27. 484– 492.
Kerns, J., Cohen, J., MacDonald, A., Cho, R., Stenger, A. & Carter, C. (2002) Anterior Cingulate Conflict Monitoring and Adjustments in Control. American Association for the Advancement of Science. 303. 1023- 1026.
Kolb, J., Farran, P., Norris, S., Smith, D. & Mester, J. (2004). Validation of Pulse Oximetry during Progressive Normobaric Hypoxia Utilizing a Portable Chamber. Canadian Journal of Applied Physiology. 29(1). 3-15.
Koller, E., Drechsel, S., Hess, T., Macherel, P. & Boutellier, U. (1988). Effect of Atropine and Propranolol on the Respiratory, Circulatory, and ECG Responses to High Altitude in Man. European Journal of Applied Physiology and Occupational Physiology. 57(2). 163-172.
Kramer, A., Erickson, K. & Colcombe, S. (2006). Exercise, Cognition, and the Aging Brain. Journal of Applied Physiology. 101 (4). 1237-1242.
Kumar, K. (2011). Hypoxia. 3. Hypoxia and Neurotransmitter Synthesis. American Journal of Physiology. 300 (4). 743-751.
Lemos, V., Antunes, H., Santos, R., Lira, F., Tufik, S. & Mello, M. (2012). High Altitude Exposure Impairs Sleep Patterns, Mood, and Cognitive Functions. Journal of psychophysiology. 49 (6). 1298-1306.
Li, X., Wu, X., Fu, C., Shen, X., Wu, Y. & Wang, T. (2000). Effects of Acute Mild and Moderate Hypoxia on Human Mood State. Space Medicine & Medical Engineering (Beijing). 13. 1–5.
Liu, X., Lu, L., Zhong, F., Cheng, H., Yaun, Q. & Ren, R. (2001). Analysis of Heart Rate Variability during Acute Exposure to Hypoxia. Space Medicine and Medical Engineering. 14(5). 328-331.
41
Mazzeo, R. (2008). Physiological Responses to Exercise at Altitude: An Update. Sports Medicine. 38 (1). 1-8.
McEwen, B. & Sapolsky, R. (1995). Stress and Cognitive Function. Current Opinion in Neurobiology. 5(2). 205-216.
McFarland, R. (1932). The Psychological Effects of Oxygen Deprivation (anoxemia) on Human
Behaviour. Archives of Psychology. 145. 1-135.
McFarland, R. (1937). Psycho-physiological Studies at High Altitude in the Andes. I. The effect
of rapid ascents by aeroplane and train. Journal of Comparative Psychology. 23 (1). 191-225.
McFarland, R. (1972). Psychophysiological Implications of Life at Altitude and Including the
Role of Oxygen in the Process of Aging. In: Yousef, M, Horvath, R & Bullard, R Physiological
adaptations: Desert and Mountain. New York: Academic Press. 157- 182.
Miller, G. (1956) The Magical Number Seven, Plus or Minus Two: Some Limits on Our Capacity for Processing Information. Psychological Review. 63 (2). 81-97.
Milner, B. (1972). Disorders of Brain Lesions in Man. Journal of Clinical Neuro-surgery. 19 (4). 421-446.
Missoum, G., Rosnet, E. & Richalet, J. (1992). Control of Anxiety and Acute Mountain Sickness in Himalayan Mountaineers. International Journal of Sports Medicine. 13. 37–39.
Muriel, K., Leathem, C. & Leathem, J. (2004). Development and Standardisation of the Computerised Finger Tapping Test: Comparison with Other Finger Tapping Instruments. New Zealand Journal of Psychology. 33 (2). 45-49.
Nehlig, A. (2004). Brain uptake and Metabolism of Ketone Bodies in Animal Models.
Nelson, R., Dickson, A. & Baǹos, J. (2000). An Automated Administration of Corsi’s Block
Tapping Test. Journal of Perceptual and Motor Skills. 91. 578-580.
Pines, A. (1979). Without Oxygen. British Medical Journal. 6170 (1). 1061-1062.
Podsakoff, P., MacKenzie, S., Lee, J. & Podsakoff, N.(2003). Common Method Biases in Behavioural Research: A Critical Review of the Literature and Recommended Remedies. Journal of Applied Psychology. 88. 879-903.
Pollard, J. & Murdoch, R. (2008). The High Altitude Medicine Handbook. Abingdon: Radcliffe Medical Press Ltd.
Prabhakar, N. (2000). Oxygen Sensing by the Carotid Body Chemorecptor. Journal of Applied Physiology. 88 (3). 2287-2295.
Raichle, M. & Mintun, M. (2006). Brain Work and Brain Imaging. Annual Review Neuroscience. 29. 449-476.
Ray, K., Dutta, A., Panjwani, U., Thakur, L., Anand, J. & Kumar, S. (2010). Hypobaric Hypoxia Modulates Brain Biogenic Amines and Disturbs Sleep Architecture. Neurochemistry International. 58(1). 112-118.
Reitan, R. & Wolfson, D. (1993). The Halstead- Reitan Neuropsychological Test Battery: Theory and Clinical Interpretation (2nd Ed). Tuscon, AZ: Neuropsychology press.
Russell, E., Neuringer, C. & Goldstein, G. (1970). Assessment of Brain Damage: A neuropsychological key approach, New York, Wiley-interscience.
Saab, P., Matthews, K., Stoney, C. & McDonald, R. (1989). Premenopausal and Post-menopausal Women Differ in their Cardiovascular and Neuroendocrine Responses to Behavioral Stressors. Psychophysiology. 26. 270-280.
Sackett, D. (1979). Bias in Analytic Research. Journal of chronic Diseases. 32(1). 51-63.
Schmidt, F., Kety, S. & Pennes, H. (1945). The Gaseous Metabolism of the Brain of the Monkey. American Journal of Physiology. 143.33–52.
Severinghaus, J., Astrup, P. & Murray, J. (1998). Blood Gas Analysis and Critical Care Medicine. American Journal of Respiratory Critical Care Medicine. 157 (2). 114-122.
Sevre, K., Bendz, B., Hanko, E., Nakstad, A., Hauge, A., Kasin, J., Lefrandt, J., Smit, A., Eide, I. & Rostrup, M. (2001). Reduced Autonomic Activity during Stepwise Exposure to High Altitude. Acta Physiological Scandinavica. 173. 409-417.
Sharp, F. & Bernaudin, M. (2004). HIF1 and Oxygen Sensing in the Brain. Nature Reviews Neuroscience. 5. 437–448.
Silberberg, M (2009). Chemistry: the molecular nature of matter and change. 5th ed. Boston: McGraw-Hill. 206.
Smith, A. (2005). Hypoxia Symptoms reported during Helicopter Operations Below 10,000 ft.: a retrospective survey. Journal of Aviation, Space and Environmental Medicine. 76 (8). 794-798.
Smith, A. (2006). The Impact of Short-Duration Light and Moderate Physical Activity at 7,000ft and 9,000ft on the Development of hypoxia. Journal of Aviation, Space and Environmental Medicine. 77 (9), 274.
Sokoloff, L. (1976). Circulation and energy metabolism of the brain. In: y Siegel G, Albers R, Katzman R & Agranoff B. Basic Neurochemistry. Boston, MA: Little Brown. 388.
Sokoloff, L., Reivich, M., Kennedy, C., Des Rosiers, M., Patlak, C., Pettigrew, K., Sakurada, O. & Shinohara, M. (1977). The [14C] deoxyglucose method for the measurement of local cerebral glucose utilization: theory, procedure, and normal values in the conscious and anesthetized albino rat. Journal of Neurochemistry. 28. 897-916.
Solomon, J. (2000). Excitation of Phrenic and Sympathetic Output During Acute Hypoxia: Contribution of Medullary Oxygen Sensors. Journal of Respiratory Physiology. 121 (1). 101-117.
Süss, H. & Schmiedek, F. (2000). Fatigue and Practice Effects during Cognitive Tasks Lasting Several Hours. Experimental Psychology.43 (3). 162-179.
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Sylvester, J., Cymerman, A., Gurtner, G., Hottenstein, O., Cote, M. & Wolfe, D. (1981) Components of Alveolar-arterial O2 Gradient during Rest and Exercise at Sea Level and High Altitude. Journal of applied physiology respiration environment exercise physiology. 50 (6). 1129-1139.
Talbot, P., Balanos, M., Dorrington. L. & Robbins, A. (2005). Two Temporal Components within the Human Pulmonary Vascular Response to 2 h of Isocapnic Hypoxia. Journal of Applied Physiology 98.1125–1139.
Thomas, M. (2007). Weather for Hill Walkers and Climbers. Cirencester: Sutton Publishing. 20-28.
Turner, C., Byblow, W. & Gant, N. (2015). Creatine Supplementation Enhances Corticomotor Excitability and Cognitive Performance during Oxygen Deprivation. Journal of Neuroscience. 35 (4). 1773-1780.
Unsworth, W. (2000). Everest: The Mountaineering History. Macclesfield: Baton Wicks Publications.
Varpula, M., Karlsson, S., Ruokonen, E. & Pettilӓ, V. (2006). Mixed Venous Oxygen Saturation Cannot Be Estimated by Central Venous Oxygen Saturation in Septic Shock. Intensive Care Medicine. 32. 1336-1343.
Virués-Ortega, J., Buela-Casal, G., Garrido, E. & Alcázar, B. (2004). Neurobehavioral Functioning Associated with High-Altitude Exposure. Neuropsychology review. 14. 197-224.
Virués-Ortega, J., Garrido, E., Javierre, C. & Kloezeman, K. (2006). Human Behaviour and
Development under High-Altitude Conditions. Journal of Developmental Science. 9 (4). 400-
410.
Wilmore, J., Costill, D. & Kenney, W. (2008). Physiology of Sport and Exercise. Leeds: Human
Kinetics.
Wu, G., Baraldo, M. & Furlanut, M. (1999). Inter-patient and intra-patient variations in the
baseline tapping test in patients with Parkinson’s disease. Acta Neurology Belgium. 99.182–4.
Zhao, L., Mason, A. & Morrell, W. (2001) Sildenafil Inhibits Hypoxia-Induced Pulmonary
Hypertension. Circulation. 104. 424–428
Zielke, H., Zielke, C. & Baab, P. (2009) Direct Measurement of Oxidative Metabolism in the
Living Brain by Microdialysis: a review. Journal of Neurochemistry. 109 (1). 24-29.
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Appendices
Appendix A – Participants informed Consent
Tel: +44 (0)1243 816000
Fax: +44 (0)1243 816080 Bishop Otter Campus,
College Lane, The University of Chichester Chichester,
West Sussex. PO19 6PE UK
Consent Form www.chiuni.ac.uk
I, …………………………………………………………. (PRINT NAME)
Herby give my consent to participate in the follow ing test/activity [please delete as appropriate].
[Insert details] To complete five exposures to a hypoxic (Low Oxygen) environment, whist lying in a supine position for five minutes. Measurements of
heart rate variability, using a three lead electrocardiograph; blood oxygen saturation; blood pressure and respiratory rate. Exposure will
be randomised. Oxygen content in the five conditions will be approximately 20.3%, 17.4%. 14.5%, 12.0% and 9.8%.
By signing this from I confirm that:
The purpose of the test/activity has been explained to me;
I am satisf ied that I understand the procedures involved;
The possible benefits and risks of the test/activity have been explained to me;
Any questions w hich I have asked about the test/activity have been answ ered to my satisfaction;
I understand that, during the course of the test/activity, I have the right to ask further questions about it;
The information w hich I have supplied to The University of Chichester prior to taking part in the test/ activity is true and
accurate to the best of my know ledge and belief and I understand that I must notify promptly of any changes to the
information;
I understand that my personal information w ill not be released to any third parties w ithout my permission;
I understand that my participation in the test/activity is voluntary and I am therefore at liberty to w ithdraw my
involvement at any stage;
I understand that, if there is any concern about the appropriateness of continuing in the test/activity, I may be asked to
w ithdraw my involvement at any stage;
I understand that once the test/activity has been completed, the information gained as a result of it w ill be used for the
This form should be used by ALL members of the University including undergraduate students, postgraduate students, staff and those in visiting or emeritus roles who wish to undertake research involving human participants under the name of the University of Chichester. You do not need to complete this form if your research does not involve human participants directly or indirectly (e.g. observation studies) (see section 4.1 of the Research Ethics Policy (REP) for more information), however, you are expected to work within the Research Ethics Policy and Researcher Code of Conduct. The University does not conduct research on animals. If your proposed project involves animals in any way please seek advice from the Research Office before proceeding.
Application for Ethical Approval: For all applications for ethical approval
Max Burrows
(Staff/PGR/Masters/UG)
THIS FORM MUST BE COMPLETED AND APPROVED by the relevant person(s) and if categorised as Category B it must be approved by the Research Ethics Committee (REC) prior to commencement of research. Full guidance on the Application process can be found in the body and appendices of the Research Ethics Policy.
REQUIRED DOCUMENTATION Each Application must be submitted alongside relevant consent forms, information letters/sheets, and debriefing sheets. This documentation should be version numbered and dated. Categorisation of applications for ethical approval
Category A projects are less likely to involve participants from vulnerable groups and/or involve sensitive issues or areas/activities that entail a level of risk of distress or harm to participants or researchers. They only need to be approved by your supervisor and do not need to be considered by the Research Ethics Committee. The Research Ethics Policy provides further guidance on categorisation and areas of risk.
Category B projects need to be considered by the Research Ethics Committee. The process of approval can take several weeks or longer depending on the number of applications being considered at any one time and the resolution of any issues that are raised by the Committee. It is fairly common for applications to be returned for further amendments prior to approval. The Committee expects applications from students to be of the same quality as those from staff. A helpful way to consider this position is to consider the research project from the point of view of the research participant.
Undergraduate or taught postgraduate student applicants: Your tutors and programme team will be able to advise you on how and when to complete this form. Your project supervisor is responsible for categorising your application as Category A or Category B and for authorising it. Communications relating to Category B applications should be between the supervisor and the clerk to the Research Ethics Committee. The student should not contact the clerk directly.
Postgraduate research students: Your PhD supervisor is responsible for categorising your application as Category A or Category B and for authorising it.
Academic Staff: Your line manager is responsible for categorising your application as Category A or Category B and for authorising it.
Emeritus or Visiting roles: The Head of Department of the area to which you are linked is responsible for categorising your application as Category A or Category B and for authorising it.
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Section A: Basic information
A1: Title of studies:
Max Burrows: Effects of Simulated Altitude on Neurobiological Functions.
A2: Name of Applicant: (in collaborative projects, just name the lead applicant) A3: Position of Applicants (e.g. UG/Masters/PGR student, academic)
A4: Programme of study: (for UG or taught Masters students only)
A5: Department of Applicant:
Max Burrows
Undergraduate Student
Adventure Education BA (Hons)
Adventure Education
A6: Checklist to ensure application is complete. Have you prepared the following documents to accompany your application for ethical approval, please tick the appropriate column for each of the following:
Document
Confirmation of Ethical Approval of any other organisation (e.g. NHS, MoD, National Offender Management Service) Recruitment information / advertisement (e.g. draft text for email/ poster/social media/letter) Information sheet for participants
Information sheet for carers/guardians
Information sheet/letter for gatekeepers e.g. Head teacher, teacher, coach Consent form for participants
Assent form for younger children Documentation relating to the permission of third parties other than the participant, guardian, carer or gatekeeper (e.g. external body w hose permission is required) Medical questionnaire / Health screening questionnaire Secondary information sheet for projects involving intentional deceit/w ithholding information
Secondary consent form for projects involving intentional deceit/w ithholding information Debrief sheet to give to participants after they have participated
Yes No
NO
N/A
YES YES
N/A N/A
YES
N/A N/A
YES N/A N/A
Yes NO No N/A
N/A
Statements about completeness of the application
For research involving under 18s or vulnerable groups, w here necessary, a statement has been included on all information sheets that the investigators have passed appropriate Disclosure and Barring Service1 checks I can confirm that the relevant documents listed above make use of document references including date and version number I can confirm that I have proof read my application for ethical approval and associated documents to minimise typographical and grammatical errors
YES
YES
Declaration of the applicant:
I confirm my responsibility to deliver the research project in accordance with the University of Chichester’s policies and procedures, which include the University’s ‘Financial Regulations’, ‘Research Ethics Policy’, ‘Data Systems and Security Policy’ and ‘Data Protection Policy’ and, where externally funded, with the terms and conditions of the research funder.
Working with under 18’s or other vulnerable groups may require a Disclosure and Barring Service Check. Contact [email protected] if you are not sure whether you have an up to date and relevant DBS check or if you require more information. Do note that a DBS check may take several weeks to obtain.
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Section C: Ethical Review Questions begin:
C1. Does the study involve human participants?
Participants in research are taken to include all those involved in the research activity either directly or indirectly and either passively, such as when being observed part of an educational context, or actively, such as when taking part in an interview procedure.
NB: the University does not conduct research on animals. If your proposed project involves animals in any way please seek advice from the Research Office before proceeding.
Yes/No
YES
If answer to C1 is ‘No’ then you do not need to complete this form and you do not need to seek formal ethical approval. Nevertheless, you are required to conduct your research in accordance with the Research Ethics Policy (REP) and Researcher Code of Conduct.
C2. Why should this research study be undertaken? Brief description of purpose of study/rationale
A wealth of research suggests that cognitive performance decreases in hypoxic conditions. With increasing altitude, barometric pressure decreases, resulting in the reduced partial pressure of oxygen (PO₂) in body tissues and the blood. Consequently, humans suffer physiological and cognitive impairments.
With the number of people travelling to high altitudes increasing, the effects of hypoxia on physiological and cognitive functioning is a subject of great interest. The safety and well -being of people who work at this level is of major concern, including their ability to make justified decisions and react quickly to inevitable changes in the environment. Risk is often amplified in high-altitude settings, therefore the consequences associated with errors in judgement or cognitive faults can be fatal. This area of research requires thorough exploration to ensure personnel at altitude are capable of completing cognitive tasks efficiently.
Although there is substantial research in this area already, to the author’s knowledge, no research to date has investigated the effects of standardised oxygen desaturation on cognitive functioning. Therefore, this study aims to eradicate some of the variables present in previous investigations, in order to gain a richer insight into the effects that hypoxia has on cognitive functioning.
In addition, cardiovascular responses are also altered as demands for oxygen change as hypoxemia occurs. Integrating this, with cognitive stressors allows us to explore what cardiovascular changes are apparent and to what nature does stress and altitude effect the normative role of the cardiovascular system.
C3a. What are you planning to do?
Provide a description of the methodology for the proposed research, including proposed method and duration of data collection, tasks assigned to participants of the research and the proposed method and duration of data analysis. If the proposed research makes use of pre-established and generally accepted techniques, e.g. established laboratory protocols, validated questionnaires, please refer to this in your answer to this question. (Do not exceed 500 words). If it is helpful for the panel to receive further documentation describing the methodology then please append this to your application and make specific reference to it in box 3a below.
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Measuring participants’ neurobiological responses to a Corsi block test, Eriksen flanker task and Finger tap test at 75% Oxygen Saturation (SaO₂). The Corsi block test assesses non-verbal memory. The Flanker test was selected for use as it has high construct validity, having been identified as a measurement for the inhibitory control, planning, and updating components of the central executive. The finger tapping test is a psychological test given to assess the integrity of the neuromuscular system and examine motor control.
The study consists of a repeated measures design, with each participant required to complete one exposure to a hypoxic environment (Environmental Chamber). The study involves 8 male, physically fit undergraduate University students. Participants volunteered for the study and will complete the consent form prior to involvement. Volunteers who smoke or have been to altitude within the last four weeks are excluded. Medical health questionnaires will be completed, in order to ensure participants are fit and suitable for testing.
Measures: Blood oxygen saturation, Heart rate, Electrocardiogram (ECG), Heart rate variability, Blood pressure. Possibility of participants becoming hypoxic during experiment as a result of a decrease in the partial pressure of oxygen. Low blood oxygen saturation (≥75%) may result from exposure to hypoxic environment.
Participants will have their height and mass recorded prior to testing. They will be briefed during their 30 minute acclimatization period inside the environmental chamber before the test begins. Participants will then begin to complete each of the three tests once. After all tests are comple ted, they will be debriefed and be allowed to leave the environmental chamber.
Monitor participants at all time. If participants shows sign/symptoms of hypoxia during the experiment they will be immediately removed from the environment chamber. If blood oxygen saturation falls below 75% they will be immediately removed from the environment chamber. Total laboratory time = 10 hours for all participants to complete all tests in each altitude.
C3b. When are you planning to do it?
Please enter the anticipated s tart and end dates of your study (Consider at which point you will be involving human participants, this would typically be in the data collection/information gathering phase of the project but may be earlier):
01/10/2014 - 26/04/2015
I will be involving human participants between w/c 09/02/2014 – w/c 23/02/2015
C4. Where will the research be undertaken?
Briefly describe the location of the study, provide details of any special facilities to be used and any factors relating to the study site/location that might give rise to additional risk of harm or distress to participants or members of the research team together with measures taken to minimise and manage such risks:
The University of Chichester, Bishop Otter Campus. Environmental Chamber/Lab.
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C5. Who are the participants?
Please indicate the number of participants in each of the groups in the table below. If the precise number of participants is not known then please make an estimate. Please enter ‘0’ in the ‘Numbers in study’ column for those groups that are not included in your study. Please note that the examples provided of different sorts of vulnerability are not an exhaustive list.
Participant
Adults with no known2 health or social problems i.e. not in a vulnerable group:
Children aged 16-173 with no known3 health or social problems:
Children under 16 years of age with no known3 health or social problems:
Adults who would be considered as vulnerable e.g. those in care, with learning difficulties, a disability, homeless, English as a second language, service users of mental health services, with reduced mental capacity4
Identify reason for being classed as vulnerable group and indicate ‘numbers in study’ in next column adjacent to each reason (expand the form as necessary):
………………………………………………..
………………………………………………..
Children (aged <18) who would be considered as particularly vulnerable e.g. those in care, with learning difficulties, disability, English as a second language
Identify reason for being classed as vulnerable group and indicate ‘numbers in study’ in next column adjacent to each reason (expand the form as necessary):
………………………………………………..
………………………………………………..
Other participants not covered by the categories listed above (please list):
List other categories here: ……………………………………………..
0
0
Numbers in study
8
0
0
0
C6a. Is there something about the context and/or setting which means that the potential risk of harm/distress to participants or research is lower than might be expected?
Answer: Yes
Consider if the study is part of routine activity which involves persons with whom you normally work in a typical work context e.g. Teachers working with children in a classroom setting, researchers in the performing arts working with performers, sports coaches working with athletes/players or research involving students in an academic setting.
Optional: Further information to justify answer to 6a
2
3
Known to the researcher
A summary of UK definition of ‘Child’ : http://www.nspcc.org.uk/Inform/research/briefings/definition_of_a_child_wda59396.html
ity_Act_code_of_practice.pdf
Research Ethics Policy approved at Academic Board 18/6/14. Pro-forma approved at Research Ethics Committee 01/07/2014
Participants will be in a controlled laboratory environment. Participants will be required to wear a pulse oximeter, if blood oxygen saturation falls below 75% they will be immediately removed from the environmental chamber.
Participants will be monitored at all times for signs/symptoms of hypoxia. Signs and symptoms that will be observed to give indication of hypoxia will be light-headedness, tingling of extremities, dizziness , nausea, fatigue, confusion and behavioural changes. Oxygen bottles will be available to participants if they require them.
All participants have the right to stop the experiment at any point.
C6b. Are there any conflicts of interests which need to be considered and addressed? (For example, does the research involve students whom you teach, colleagues, fellow students, family members? Do any of the researchers or participants have any vested interest in achieving a particular outcome? See section 9 of the Research Ethics Policy (REP))
Answer: NO
If conflicts of interest are envisaged, indicate how they have been addressed:
C7. How will potential participants in the study be identified, approached and recruited?
Please include details of:
Basis for selection of participants in the study: e.g. participants must be clinically obese adults; participants must be social workers over the age of 50; participants must have achieved Grade 5 in an appropriate musical instrument Any criteria for exclusions (e.g. participants declaring a heart problem will be excluded) How the selection criteria will be applied e.g. Health questionnaire completed prior to joining the study
The means by which the participants will be recruited (e.g. through an advert, through a school, through a sports club), please be specific about the medium of the advertisement/recruitment information (e.g. poster, email, website, social media, word of mouth) and mention any third parties who may be involved in supporting the recruitment.
8 male, right handed volunteers were recruited via word of mouth. Exclusion criteria: Overt Diseases, Medication, Smokers and anyone to have travelled to altitude recently (≥2 months).
C8. Will any payment, gifts, rewards or inducements be offered to participants to take part in the study? See section 11 of the REP.
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Answer: NO
Please provide brief details and a justification:
C9a. Is the process of the study and/or its results likely to produce distress, anxiety or harm in the participants even if this would be what they would normally experience in your work with them? See section 5 of the REP.
Answer: YES
If you answered Yes to 9a, please answer 9b below:
C9b. Is the process of the study and/or its results likely to produce distress or anxiety in the participants beyond what they would normally experience in your work with them?
Answer: NO
If yes this Application must be categorised as ‘B’
Please provide details:
C9c. What steps will you take to deal with any distress or anxiety produced?
E.g. have a relevant professional on-hand to support distressed/anxious participants. Careful signposting to counselling or other relevant professional services. Other follow-up support.
Participants will be briefed before the experiment and debriefed after the experiment. They will be allowed to withdraw at any time.
C9d. What is the potential for benefit to research participants, if any? E.g. Participants may gain an increased awareness of hypoxia issues or acquire new knowledge of themselves.
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Participants may gain an insight into how their body reacts at altitude. Plus, how the cardiovascular system changes as the body undergoes stress in different levels of oxygen.
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C10. Will the study involve withholding information or misleading participants as part of its methodology? (Please refer to sections 6.11 and 10 of the REP for further guidance)
Answer: NO
If ‘yes’ this Application must be categorised as ‘B’
Please provide details:
C11a. Does your proposal raise other ethical issues apart from the potential for distress, anxiety, or harm?
Answer: NO
C11b. If your answer to C11a. was ‘yes’, please briefly describe those ethical issues and how you intend to mitigate them and/or manage them in the proposed study.
C11c Does your proposed study give rise to any potential risk of harm or distress to yourself or other members of the research team? OR is there any risk that you could find yourself in a vulnerable position as you carry out your study.
Answer: YES
If you answer ‘yes’ to either of these points please explain briefly what the risks are and what steps you are taking in order to minimise and manage those risks.
For example does your study involve you in 1-1 interviews in a private setting that might suggest precautions need to be taken relating to lone-working (See section 9 of the REP), Have you considered the likelihood of a participant(s) disclosing sensitive information to you about illegal or harmful behaviour and what actions you would take in such circumstances?
I will be exposed to the hypoxic conditions for long periods of time. I will have frequent breaks and I will be rotating with two other members in order to minimise the risks of exposure to the hypoxic environment.
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C12. Will informed consent of the participants be obtained and if so, how?
Answer: YES
See section 6 of the REP to help you answer this question. Section 6.2 covers research that involves observing behaviour in a public place where gaining informed consent may not be practical or feasib le.
When and how will informed consent be obtained? Will it be written or oral consent bearing mind that oral consent will not be considered adequate other than in exceptional circumstances and must be appropriately justified in your application?
NB: Ethical approval should, as a principle, be sought before research participants are approached.
Participants will complete a consent form which will provide an outline of the experiment includin g the potential risks that are involved. It will inform participants how long they will be required for and that they have the right to stop the experiment at any point.
C13. Is there anyone whose permission should be sought in order to conduct your study? E.g. Headteacher of a school, parents/guardians of child participants.
Answer: NO
When and how will informed consent be obtained and from whom? Will it be written or oral consent bearing mind that oral consent will not be considered adequate other than in exceptional circumstances and must be appropriately justified in your application? If you are seeking to gain ‘loco parentis’ consent from a school rather than seeking individual parental consent please describe your reasoning.
C14. Do you need to seek the permission of any other organisations, individuals or groups other than outlined in section 13? E.g. the Research Ethics Committee of partner or participating organisations. Organisations like the NHS and the Prison Service have specific systems for granting ethical approval for research.
Answer: NO
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Please note that all applications must go through the University of Chichester Application for Ethical Approval process and that they must meet the Research Ethics Policy (REP) requirements. Other prior approval will be taken into account but will not in itself be sufficient to gain University Research Ethics Approval. Each application must normally be accompanied by evidence (e.g. formal statement from the appropriate Ethics Committee) confirming approval by the external body (and any concerns/issues identified). In cases where an external body requires prior approval from the University Research Ethics Policy (such as some NHS work) the Research Ethics Committee (REC) may grant in principle approval pending written confirmation of ethical approval by the external body.
Please describe the permission that is required and how you will be seeking that permission: Please attach any relevant documentation e.g. letter, that relates to the seeking of the relevant permissions.
C15. It is normally required that a participant’s data is treated confidentiality at the outset of, during and after the research study. Will this be the case?
Answer: YES
If the answer is ‘yes’ please describe how you will be maintaining the confidentiality of participants’ data. If the answer is ‘no’ please justify the exceptional circumstances that mean that confidentiality will not be guaranteed. See section 7 of the REP.
Please make reference to measures you are taking to ensure security of data from the point of data collection, transfer from notebooks/voice recorders etc., onto secure devices, to the point of analysis, sharing and final storage. Actions should be in accordance with the University’s Data Systems and Security Policy and Data Protection Policy (in particular see Appendix 4 of the Data Protection Policy for guidance for University staff).
Please provide details:
All participants will be kept anonymous. All data will be stored on an encrypted USB data stick. All data will be destroyed after the results have been gathered and sorted.
C16. It is normally required that the anonymity of participants is maintained and/or that an individual’s responses are not linked with their identity. Will this be the case?
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Answer: YES
If the answer is ‘yes’ please describe how you will be maintaining the anonymity of participants. If the answer is ‘no’ please justify the circumstances that mean that anonymity will not be guaranteed. See section 7 of the REP. NB: in group studies it is likely that each individual in the group will be aware that others in the group are participating in the study – they are therefore not anonymous to each other. However, their identity should not normally be associated with their individual responses. In some studies individual participants may not want their identify known to other participants and the study must be designed and undertaken accordingly.
Please provide details:
Participants will be placed into groups and numbered. Participants will not interact with one another. Discussion of participants will be strictly prohibited.
C17. Will participants have a right to comment or veto material you produce about them?
Answer: YES
Please give details and if your answer is ‘no’ then please provide a justification.
Participants will be provided an opportunity to give feedback about the experiment after they have completed it.
C18. Does the project involve the use of or generation/creation of audio, audio visual or electronic material (e.g. Dictaphone recording, video recording) directly relating to the participants?
Answer: YES
If yes, please describe how the collection and storage of this will be managed bearing in mind data protection and anonymity issues (see section 7 of the REP).
ECG, Heart rate variability. Data will be collected via an ECG and stored on an encrypted USB data stick.
C19. How will the participants be debriefed?
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It is expected that wherever possible all participants will receive some form of debriefing. This might be a verbal debriefing or a written debriefing depending on the context of the study. Debriefing provides an opportunity to remind participants of the procedures and outcomes of the research, and to provide further assurances on areas such as confidentiality, anonymity, and retention of data. Projects that intentionally withhold information or deceive as part of their methodology must include a written debrief sheet. (Please refer to sections 6.1 and 6.2 of the REP for further guidance)
Participants will be verbally debriefed after the experiment. Information will be given about where to go if they feel unwell and what will happen to the information that was collected about them.
C20a. Might the research entail a higher than normal risk of damage to the reputation of the University, since it will be undertaken under its auspices? (e.g. research with a country with questionable human rights, research with a tobacco company. See section 9.3 of the REP).
Answer: NO
C20b. If your answer to 20a was yes, please describe the potential risk to the University’s reputation and how this risk will be mitigated.
C21. Will your results be available in the public arena? (e.g. publication in journals, books, shown or performed in a public space, presented at a conference, internet publication and placing a dissertation in the library. See section 8 of the REP.
Answer: NO
If yes, please provide brief details:
NB: Have you considered the date by which it would be impractical for participants to withdraw their data from your study? Once you have begun to analyse the data or prepare it for publication it is reasonable for you to state that it will not be possib le for a participant to request that their data is removed from the study. You need to make this clear on the information sheet.
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C22. Are there any additional comments or information you consider relevant, or any additional information that you require from the Committee?
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Appendix D- Information Sheet
Information Sheet
[Adventure Education] Academic Department
PLEASE READ THE FOLLOWING CAREFULLY
Study titles:
The influence of acute simulated high altitude on cognitive abilities and neurobiological functions
We would like to invite you to take part in a research study. Before you decide you need to
understand why the research is being done and what it would involve for you. Please take time to
read the following information carefully.
What is the purpose of the research and how will the research be carried out?
This study is important as it can be related to many aspects in the adventure environment. The ability
for humans to adapt physically and mentally to their surrounding environments is essent ial for them
to succeed. The effects of hypoxia, on human physiology are complex, involving the respiratory,
cardiovascular and cerebrovascular systems and their associated autonomic control. This study will
help to uncover key changes that take place within the human body due to hypoxia.
What will you be asked to do?
- You will need to be in an altitude chamber for up to 1 hour 15 minutes, four times.
- You will be required to complete three short cognitive tasks up to 6 times.
The level of detail will be study specific and will depend on the complexity of each research
project.
- You will be given a time slot that you will be required to turn up to.
- There will be no follow up experiments, videoing or interviews.
- Please be aware that if you are a smoker or have recently (1 month) returned from
altitude (3000m <) then you are unable to participate in this study.
- You must not suffer from any cardiac or respiratory diseases
- This is a male only experiment.
- You must be right-handed.
What are the anticipated benefits of participating in the research?
There will be no physical or mental benefits; however you will be contributing to the further
understanding of hypoxia at simulated altitudes and may learn something about your own responses
to hypoxic conditions. The research gathered will be used to further study the effect of altitude.
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Are there any risks associated with participating in the research?
Hypobaric Hypoxia is defined as a reduction in the partial pressure of oxygen, therefore participants
may experience light headedness and/or dizziness. These effects are normally experienced at more
extreme altitudes than this study involves. All participants have the right to leave the chamber if they
begin to experience these effects. Furthermore all participants will be monitored during the entire
time the experiment is taking place.
Do you have to take part?
You are voluntarily agreeing to participate in this study therefore you have the right to leave the
study at any time without reason.
Who can you contact if you have any questions about the project?