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

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Orléans, France, 45067
        • CHR d'Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Virgile AMIOT, Ph, CHR Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2016

Primary Completion (Actual)

November 20, 2017

Study Completion (Actual)

November 20, 2017

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

March 24, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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