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Acute and Chronic Effects of Dynamic Apnea in Healthy Untrained Subjects (APNEX)

Primary Purpose

Apnea

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Program of training with exercises including apnea
Program of training with exercises without apnea
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Apnea focused on measuring dynamic apnea, muscle oxygenation, physical performance

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHR d'Orléans

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Apnea Group (GApn)

Control Group (GC)

Arm Description

Program of training with exercises including apneas

Program of training with exercises without apnea

Outcomes

Primary Outcome Measures

Spectometry to measure hemoglobin rate
Measurement of oxygenation
Wingate test to measure maximum consumption of dioxygen
Measurement of aerobic performance
Measurement of hormonal markers
Measurement of Dehydroepiandrostenedione (DHEA)
Jaeger debimeter system to measure of peak oxygen
Measurement of oxygen consumptiom
Measurement of arterial saturation in dioxygen
Measurement by ear blood micro-sample
Spectometry to measure hemoglobin
Measurement of oxygenation
Measurement of hormonal markers
Measurement of Dehydroepiandrostenedione (DHEA)
Jaeger debimeter system to measure of peak oxygen
Measurement of oxygen consumption,
Measurement of arterial saturation in dioxygen
Measurement by ear blood micro-sample

Secondary Outcome Measures

Cardiac frequency
measurement with a 12 lead - Electrocardiogamm
Cardiac frequency
measurement with a 12 lead - Electrocardiogramm
Borg scale to measure penibility of the effort
Borg scale to measure penibility of the effort

Full Information

First Posted
September 27, 2016
Last Updated
May 2, 2018
Sponsor
Centre Hospitalier Régional d'Orléans
Collaborators
Laboratoire de Complexité, Innovation et Activités Motrices et Sportives
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1. Study Identification

Unique Protocol Identification Number
NCT03095677
Brief Title
Acute and Chronic Effects of Dynamic Apnea in Healthy Untrained Subjects
Acronym
APNEX
Official Title
Acute and Chronic Effects of Dynamic Apnea in Healthy Untrained Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 8, 2016 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
Collaborators
Laboratoire de Complexité, Innovation et Activités Motrices et Sportives

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea
Keywords
dynamic apnea, muscle oxygenation, physical performance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apnea Group (GApn)
Arm Type
Experimental
Arm Description
Program of training with exercises including apneas
Arm Title
Control Group (GC)
Arm Type
Other
Arm Description
Program of training with exercises without apnea
Intervention Type
Other
Intervention Name(s)
Program of training with exercises including apnea
Intervention Description
16 training session on cycle ergometry with exercises including apneas.
Intervention Type
Other
Intervention Name(s)
Program of training with exercises without apnea
Intervention Description
16 training session on cycle ergometry with exercises without apnea
Primary Outcome Measure Information:
Title
Spectometry to measure hemoglobin rate
Description
Measurement of oxygenation
Time Frame
3 weeks
Title
Wingate test to measure maximum consumption of dioxygen
Description
Measurement of aerobic performance
Time Frame
3 weeks
Title
Measurement of hormonal markers
Description
Measurement of Dehydroepiandrostenedione (DHEA)
Time Frame
3 weeks
Title
Jaeger debimeter system to measure of peak oxygen
Description
Measurement of oxygen consumptiom
Time Frame
3 weeks
Title
Measurement of arterial saturation in dioxygen
Description
Measurement by ear blood micro-sample
Time Frame
3 weeks
Title
Spectometry to measure hemoglobin
Description
Measurement of oxygenation
Time Frame
12 weeks
Title
Measurement of hormonal markers
Description
Measurement of Dehydroepiandrostenedione (DHEA)
Time Frame
12 weeks
Title
Jaeger debimeter system to measure of peak oxygen
Description
Measurement of oxygen consumption,
Time Frame
12 weeks
Title
Measurement of arterial saturation in dioxygen
Description
Measurement by ear blood micro-sample
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cardiac frequency
Description
measurement with a 12 lead - Electrocardiogamm
Time Frame
3 weeks
Title
Cardiac frequency
Description
measurement with a 12 lead - Electrocardiogramm
Time Frame
12 weeks
Title
Borg scale to measure penibility of the effort
Time Frame
week 3
Title
Borg scale to measure penibility of the effort
Time Frame
week 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virgile AMIOT, Ph
Organizational Affiliation
CHR ORLEANS
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12183481
Citation
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.
Results Reference
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PubMed Identifier
10677392
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.
Results Reference
background
PubMed Identifier
18097682
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. doi: 10.1007/s00421-007-0639-9. Epub 2007 Dec 19.
Results Reference
background
PubMed Identifier
16540709
Citation
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.
Results Reference
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Acute and Chronic Effects of Dynamic Apnea in Healthy Untrained Subjects

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