ApneaAPNEXNCT03095677
Acute and Chronic Effects of Dynamic Apnea in Healthy Untrained Subjects
A study testing Program of training with exercises including apnea and Program of training with exercises without apnea in people with Apnea, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Apnea
- What is being tested?
- Program of training with exercises including apnea and Program of training with exercises without apnea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2016to 20 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Apnea
- Being tested
- Program of training with exercises including apnea, Program of training with exercises without apnea
- Keywords
- dynamic apnea, muscle oxygenation, physical performance
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program of training with exercises including apneaOther
16 training session on cycle ergometry with exercises including apneas.
Program of training with exercises without apneaOther
16 training session on cycle ergometry with exercises without apnea
| Study group | Role | What they receive |
|---|---|---|
| Apnea Group (GApn) | Experimental | Program of training with exercises including apneas Receives: Other: Program of training with exercises including apnea |
| Control Group (GC) | Other | Program of training with exercises without apnea Receives: Other: Program of training with exercises without apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectometry to measure hemoglobin rate
Measurement of oxygenation
Measured: 3 weeks
Wingate test to measure maximum consumption of dioxygen
Measurement of aerobic performance
Measured: 3 weeks
Measurement of hormonal markers
Measurement of Dehydroepiandrostenedione (DHEA)
Measured: 3 weeks
Jaeger debimeter system to measure of peak oxygen
Measurement of oxygen consumptiom
Measured: 3 weeks
Measurement of arterial saturation in dioxygen
Measurement by ear blood micro-sample
Measured: 3 weeks
Spectometry to measure hemoglobin
Measurement of oxygenation
Measured: 12 weeks
Measurement of hormonal markers
Measurement of Dehydroepiandrostenedione (DHEA)
Measured: 12 weeks
Jaeger debimeter system to measure of peak oxygen
Measurement of oxygen consumption,
Measured: 12 weeks
Measurement of arterial saturation in dioxygen
Measurement by ear blood micro-sample
Measured: 12 weeks
Secondary outcomes (4)
Cardiac frequency
measurement with a 12 lead - Electrocardiogamm
Measured: 3 weeks
Cardiac frequency
measurement with a 12 lead - Electrocardiogramm
Measured: 12 weeks
Borg scale to measure penibility of the effort
Measured: week 3
Borg scale to measure penibility of the effort
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start8 Apr 2016
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Complexité, Innovation et Activités Motrices et Sportives
- Responsible party
- Sponsor
- Investigators
- Virgile AMIOT, Ph, Principal investigator, CHR ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095677
- Sponsor's protocol ID
- CHRO-2015-01
- Acronym
- APNEX
- Status last verified
- May 2018
- First submitted
- 27 Sep 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12183481Caquelard 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.
PubMed 10677392de 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.
PubMed 18097682Dufour 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.
PubMed 16540709
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effects of Dynamic Apnea in Healthy Untrained Subjects
- ClinicalTrials.gov ID
- NCT03095677
- Acronym / sponsor ID
- APNEX / CHRO-2015-01
- Conditions
- Apnea
- Keywords
- dynamic apnea, muscle oxygenation, physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Collaborators
- Laboratoire de Complexité, Innovation et Activités Motrices et Sportives
- Study start
- 8 Apr 2016 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apnea Group (GApn) | Experimental | Other: Program of training with exercises including apneaProgram of training with exercises including apneas |
| Control Group (GC) | Other | Other: Program of training with exercises without apneaProgram of training with exercises without apnea |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program of training with exercises including apnea16 training session on cycle ergometry with exercises including apneas. | Other | Apnea Group (GApn) |
| Program of training with exercises without apnea16 training session on cycle ergometry with exercises without apnea | Other | Control Group (GC) |
Primary outcome
Spectometry to measure hemoglobin rate
Time frame: 3 weeks
Measurement of oxygenation
Wingate test to measure maximum consumption of dioxygen
Time frame: 3 weeks
Measurement of aerobic performance
Measurement of hormonal markers
Time frame: 3 weeks
Measurement of Dehydroepiandrostenedione (DHEA)
Jaeger debimeter system to measure of peak oxygen
Time frame: 3 weeks
Measurement of oxygen consumptiom
Measurement of arterial saturation in dioxygen
Time frame: 3 weeks
Measurement by ear blood micro-sample
Spectometry to measure hemoglobin
Time frame: 12 weeks
Measurement of oxygenation
Measurement of hormonal markers
Time frame: 12 weeks
Measurement of Dehydroepiandrostenedione (DHEA)
Jaeger debimeter system to measure of peak oxygen
Time frame: 12 weeks
Measurement of oxygen consumption,
Measurement of arterial saturation in dioxygen
Time frame: 12 weeks
Measurement by ear blood micro-sample
4 secondary outcomes
Cardiac frequency
Time frame: 3 weeks
Cardiac frequency
Time frame: 12 weeks
Borg scale to measure penibility of the effort
Time frame: week 3
Borg scale to measure penibility of the effort
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Background: PubMed 12183481Andersson 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.
- Background: PubMed 10677392Caquelard 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.
- Background: PubMed 18097682de 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.
- Background: PubMed 16540709Dufour 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virgile AMIOT, Ph principal investigator
CHR ORLEANS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program of training with exercises including apnea and Program of training with exercises without apnea in people with Apnea, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectometry to measure hemoglobin rate (time frame: 3 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03095677, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.