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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03095677
Other study ID # CHRO-2015-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 8, 2016
Est. completion date November 20, 2017

Study information

Verified date May 2018
Source Centre Hospitalier Régional d'Orléans
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date November 20, 2017
Est. primary completion date November 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Program of training with exercises including apnea
16 training session on cycle ergometry with exercises including apneas.
Program of training with exercises without apnea
16 training session on cycle ergometry with exercises without apnea

Locations

Country Name City State
France CHR d'Orléans Orléans

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Régional d'Orléans Laboratoire de Complexité, Innovation et Activités Motrices et Sportives

Country where clinical trial is conducted

France, 

References & Publications (4)

Andersson JP, Linér MH, Rünow 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. — View Citation

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. — View Citation

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. Epub 2007 Dec 19. — View Citation

Dufour SP, Ponsot E, Zoll J, Doutreleau S, Lonsdorfer-Wolf E, Geny B, Lampert E, Flück 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Spectometry to measure hemoglobin rate Measurement of oxygenation 3 weeks
Primary Wingate test to measure maximum consumption of dioxygen Measurement of aerobic performance 3 weeks
Primary Measurement of hormonal markers Measurement of Dehydroepiandrostenedione (DHEA) 3 weeks
Primary Jaeger debimeter system to measure of peak oxygen Measurement of oxygen consumptiom 3 weeks
Primary Measurement of arterial saturation in dioxygen Measurement by ear blood micro-sample 3 weeks
Primary Spectometry to measure hemoglobin Measurement of oxygenation 12 weeks
Primary Measurement of hormonal markers Measurement of Dehydroepiandrostenedione (DHEA) 12 weeks
Primary Jaeger debimeter system to measure of peak oxygen Measurement of oxygen consumption, 12 weeks
Primary Measurement of arterial saturation in dioxygen Measurement by ear blood micro-sample 12 weeks
Secondary Cardiac frequency measurement with a 12 lead - Electrocardiogamm 3 weeks
Secondary Cardiac frequency measurement with a 12 lead - Electrocardiogramm 12 weeks
Secondary Borg scale to measure penibility of the effort week 3
Secondary Borg scale to measure penibility of the effort week 12
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