NCT03095677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

September 27, 2016

Last Update Submit

May 2, 2018

Conditions

Keywords

dynamic apneamuscle oxygenationphysical performance

Outcome Measures

Primary Outcomes (9)

  • Spectometry to measure hemoglobin rate

    Measurement of oxygenation

    3 weeks

  • Wingate test to measure maximum consumption of dioxygen

    Measurement of aerobic performance

    3 weeks

  • Measurement of hormonal markers

    Measurement of Dehydroepiandrostenedione (DHEA)

    3 weeks

  • Jaeger debimeter system to measure of peak oxygen

    Measurement of oxygen consumptiom

    3 weeks

  • Measurement of arterial saturation in dioxygen

    Measurement by ear blood micro-sample

    3 weeks

  • Spectometry to measure hemoglobin

    Measurement of oxygenation

    12 weeks

  • Measurement of hormonal markers

    Measurement of Dehydroepiandrostenedione (DHEA)

    12 weeks

  • Jaeger debimeter system to measure of peak oxygen

    Measurement of oxygen consumption,

    12 weeks

  • Measurement of arterial saturation in dioxygen

    Measurement by ear blood micro-sample

    12 weeks

Secondary Outcomes (4)

  • Cardiac frequency

    3 weeks

  • Cardiac frequency

    12 weeks

  • Borg scale to measure penibility of the effort

    week 3

  • Borg scale to measure penibility of the effort

    week 12

Study Arms (2)

Apnea Group (GApn)

EXPERIMENTAL

Program of training with exercises including apneas

Other: Program of training with exercises including apnea

Control Group (GC)

OTHER

Program of training with exercises without apnea

Other: Program of training with exercises without apnea

Interventions

16 training session on cycle ergometry with exercises including apneas.

Apnea Group (GApn)

16 training session on cycle ergometry with exercises without apnea

Control Group (GC)

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR d'Orléans

Orléans, 45067, France

Location

Related Publications (4)

  • 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.

    PMID: 12183481BACKGROUND
  • 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.

    PMID: 10677392BACKGROUND
  • 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.

    PMID: 18097682BACKGROUND
  • 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.

    PMID: 16540709BACKGROUND

MeSH Terms

Conditions

Apnea

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Virgile AMIOT, Ph

    CHR ORLEANS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

March 30, 2017

Study Start

April 8, 2016

Primary Completion

November 20, 2017

Study Completion

November 20, 2017

Last Updated

May 7, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations