Effect of Intermittent Hypoxia on Ventilatory Endurance in Healthy Volunteers

NCT06714435 | Completed DMC

• 1 other identifier: ENDUR-HYPOX
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep apnoea syndrome is a common disorder responsible for poor sleep quality and repeated oxygen depletion in the blood. Patients suffering from this disease experience a reduction in their endurance, i.e. their ability to make prolonged efforts. This loss of muscular endurance affects breathing in particular. It is known that poor sleep reduces endurance, but it is not knwon whether the repeated lack of oxygen for several hours at night also has this effect. This information could help improve the management of certain acute respiratory illnesses (asthma attacks, respiratory infections, etc.). This project therefore seeks to establish a link between repeated oxygen deprivation and a reduction in the human brain's ability to train respiratory muscles. To this end, the healthy volunteers in this study will perform the same breathing exercise (breathing for as long as possible through a mask that makes inspiration difficult) twice: once after 6 hours' exposure to repeated oxygen deprivation, and once under conditions of normal oxygenation. The order of these exercises will be randomized. These exercises will take place in a special room, a hypoxia chamber, where it is possible to deplete the air breathed in oxygen.

Conditions

Intermittent Hypoxia; Respiratory Endurance

Outcome Measures

Primary Outcomes (1)

• To compare the inspiratory endurance of healthy volunteers after 6h of continuous breathing in room air and after 6h of continuous exposure to intermittent hypoxia in a hypoxic chamber.

  through study completion, an average of 2 years

Secondary Outcomes (8)

• After 6 h of continuous breathing in room air and after 6 h of continuous exposure to intermittent hypoxia in a hypoxic chamber, compare Maximum Inspiratory Pressure (PImax) before and after the inspiratory endurance test.

  through study completion, an average of 2 years

• Compare inspiratory cortical control measured by EEG over the first 15 and last 15 minutes of the inspiratory endurance test after 6 h of continuous breathing in room air and after 6 h of continuous exposure to intermittent hypoxia in a hypoxic chamber.

  through study completion, an average of 2 years

• Compare respiratory discomfort with a visual analog scale at the start of the endurance test after 6 h of continuous breathing in room air and after 6 h of continuous exposure to intermittent hypoxia in a hypoxic chamber.

  through study completion, an average of 2 years

• Compare the time to onset of respiratory discomfort in the inspiratory endurance test with a visual analog scale after 6 h of continuous breathing in room air and after 6 h of continuous exposure to intermittent hypoxia in a hypoxic chamber.

  through study completion, an average of 2 years

• Compare sensory perception of inspiratory effort after 6 h of continuous breathing in room air and after 6 h of continuous exposure to intermittent hypoxia in a hypoxic chamber.

  through study completion, an average of 2 years

Other Outcomes (1)

• To compare the somnolence of healthy volunteers after 6h of continuous breathing in room air and after 6h of continuous exposure to intermittent hypoxia in a hypoxic chamber.

  through study completion, an average of 2 years

Study Arms (2)

Groupe 1

EXPERIMENTAL

Control visit in normoxia at V1 and then test visit in intermittent hypoxia at V2

Other: Intermittent hypoxia; Other: Normoxia

Groupe 2

EXPERIMENTAL

Test visit in intermittent hypoxia at V1 and then control visit in normoxia at V2

Other: Intermittent hypoxia; Other: Normoxia

Interventions

Intermittent hypoxia OTHER

Intermittent hypoxia during 6 hours in daytime

Groupe 1; Groupe 2

Normoxia OTHER

Normoxia during 6 hours in daytime

Groupe 1; Groupe 2

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-excessive coffee drinker (\< 3 espressos / day)
• Non-smoker or weaned for 3 months and total consumption \< 10 packs/year
• With a BMI within \]18 - 25\[ kg/m².
• Benefiting from a Social Security plan or benefiting from one through a third party
• Giving free, informed and signed consent, after receiving clear and fair information about the study.
• History of respiratory or ENT disease (asthma, chronic bronchitis, COPD, respiratory allergy, swallowing disorders, oropharyngeal malformation, obstructive or central sleep apnea-hypopnea syndrome, alveolar hypoventilation syndrome)
• Respiratory, cardiovascular, muscular, neurological or diabetic pathology or disorders
• Raynaud's disease/syndrome
• History of epilepsy or history of malaise suggestive of epilepsy
• Psychiatric history requiring hospitalization
• Liver failure
• Renal insufficiency
• History of acute mountain sickness (presence during or after a stay at altitude of symptoms of vertigo, headache, nausea/vomiting and incapacitating fatigue: Lake Louise score \> 0)
• History of migraines
• Taking medications that interfere with respiratory function or cardiovascular function, or psychotropic drugs ( anxiolytic, sedative, antidepressant, neuroleptic, muscle relaxant, etc.).

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers

Poitiers, France, 86000, France

Location

Study Officials

• Céline ABONNEAU

  CHU Poitiers

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 3, 2024
• Study Start: January 16, 2025
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)