- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03095677
Acute and Chronic Effects of Dynamic Apnea in Healthy Untrained Subjects (APNEX)
The inclusion of short periods of apnea (several seconds) during exercise (i.e. dynamic apnea) induces a significant decrease in blood oxygenation and muscle tissue. To date, the immediate effects ("acute apnea") of this decrease in the quantity of oxygen available at the muscle and brain level are poorly understood. Moreover, a physical training during which these short periods of apnea ("chronic apnea") would be included could lead to physiological adaptations and to improvement in physical performance similar to those obtained during altitude training.
The purpose of this study is to evaluate the effects of acute dynamic apnea on metabolism.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Orléans, France, 45067
- CHR d'Orléans
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The cutaneous thickness at the vastus lateralis level lower than 1.5 cm to obtain the reliable muscle oxygenation measurement
- Subjects will have to sign the inform consent before the beginning of the study
Exclusion Criteria:
- Contraindications to regular physical exercise practice
- To practice an endurance sport more than 1h/week
- Regular practice of apnea
- Chronic use of cannabis and/or alcohol
- Cardiac or metabolic pathology
- Asthma and/or bronchodilatator treatment
- ECG abnormality at rest
- Regular consumption of tobacco
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Apnea Group (GApn)
Program of training with exercises including apneas
|
16 training session on cycle ergometry with exercises including apneas.
|
|
Other: Control Group (GC)
Program of training with exercises without apnea
|
16 training session on cycle ergometry with exercises without apnea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spectometry to measure hemoglobin rate
Time Frame: 3 weeks
|
Measurement of oxygenation
|
3 weeks
|
|
Wingate test to measure maximum consumption of dioxygen
Time Frame: 3 weeks
|
Measurement of aerobic performance
|
3 weeks
|
|
Measurement of hormonal markers
Time Frame: 3 weeks
|
Measurement of Dehydroepiandrostenedione (DHEA)
|
3 weeks
|
|
Jaeger debimeter system to measure of peak oxygen
Time Frame: 3 weeks
|
Measurement of oxygen consumptiom
|
3 weeks
|
|
Measurement of arterial saturation in dioxygen
Time Frame: 3 weeks
|
Measurement by ear blood micro-sample
|
3 weeks
|
|
Spectometry to measure hemoglobin
Time Frame: 12 weeks
|
Measurement of oxygenation
|
12 weeks
|
|
Measurement of hormonal markers
Time Frame: 12 weeks
|
Measurement of Dehydroepiandrostenedione (DHEA)
|
12 weeks
|
|
Jaeger debimeter system to measure of peak oxygen
Time Frame: 12 weeks
|
Measurement of oxygen consumption,
|
12 weeks
|
|
Measurement of arterial saturation in dioxygen
Time Frame: 12 weeks
|
Measurement by ear blood micro-sample
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac frequency
Time Frame: 3 weeks
|
measurement with a 12 lead - Electrocardiogamm
|
3 weeks
|
|
Cardiac frequency
Time Frame: 12 weeks
|
measurement with a 12 lead - Electrocardiogramm
|
12 weeks
|
|
Borg scale to measure penibility of the effort
Time Frame: week 3
|
week 3
|
|
|
Borg scale to measure penibility of the effort
Time Frame: week 12
|
week 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: Virgile AMIOT, Ph, CHR Orléans
Publications and helpful links
General Publications
- de Bruijn R, Richardson M, Schagatay E. Increased erythropoietin concentration after repeated apneas in humans. Eur J Appl Physiol. 2008 Mar;102(5):609-13. doi: 10.1007/s00421-007-0639-9. Epub 2007 Dec 19.
- Andersson JP, Liner MH, Runow E, Schagatay EK. Diving response and arterial oxygen saturation during apnea and exercise in breath-hold divers. J Appl Physiol (1985). 2002 Sep;93(3):882-6. doi: 10.1152/japplphysiol.00863.2001.
- Caquelard F, Burnet H, Tagliarini F, Cauchy E, Richalet JP, Jammes Y. Effects of prolonged hypobaric hypoxia on human skeletal muscle function and electromyographic events. Clin Sci (Lond). 2000 Mar;98(3):329-37.
- Dufour SP, Ponsot E, Zoll J, Doutreleau S, Lonsdorfer-Wolf E, Geny B, Lampert E, Fluck M, Hoppeler H, Billat V, Mettauer B, Richard R, Lonsdorfer J. Exercise training in normobaric hypoxia in endurance runners. I. Improvement in aerobic performance capacity. J Appl Physiol (1985). 2006 Apr;100(4):1238-48. doi: 10.1152/japplphysiol.00742.2005.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRO-2015-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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