How intermittent hypoxia affects loop gain in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Healthy adults aged 18 to 45 will undergo periods of intermittent hypoxia and normoxia to see if the breathing control system becomes more unstable. The trial aims to understand whether intermittent low oxygen exposure can increase loop gain and contribute to breathing irregularities. Researchers will monitor safety and study breathing responses in a controlled setting at Poitiers University Hospital. The study does not involve a disease condition and uses healthy volunteers to explore fundamental mechanisms. No treatment or long-term therapy is being tested at this time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Healthy subjects aged 18 to 45
* BMI between \[18-25\] kg/m2
* No known sleep disorders
* Free subjects, not under guardianship or curatorship or subordination
* Persons affiliated with or beneficiaries of a Social Security scheme
* Signature of informed consent after clear and honest information about the study

Non-inclusion Criteria:

* Active smoking or cessation within the last 3 months and total consumption \> 10 pack-years
* Alcohol or drug addiction
* Excessive coffee consumption (\> 3 espressos/day)
* History of acute mountain sickness (presence of symptoms such as dizziness, headaches, nausea/vomiting, and incapacitating fatigue during or after a stay at high altitude)
* Living at high altitude (above 3,000 meters, continuously for more than 6 months during the last 10 years)
* History of respiratory and/or cardiovascular and/or renal and/or neurological disease (migraines, epilepsy)
* Diabetes
* Anemia, sickle cell anemia
* Any medication associated with oxygen metabolism and any psychotropic medication (anxiolytics, sedatives, antidepressants, neuroleptics, muscle relaxants, etc.) that may interfere with motor and respiratory control, muscle strength, or sleep quality
* Women of childbearing age who do not use effective contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy)
* Concurrent participation in another clinical research study affecting respiratory control or respiratory muscles
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by judicial or administrative decision, persons staying in a healthcare facility

Post-inclusion exclusion criteria:

* SpO2 \< 97% in ambient air at rest.
* Detection of pregnancy in women of childbearing age.
* Detection of acute mountain sickness (Lake Louise score \> 0).
* Abnormalities in spirometry, ventilatory polygraphy, electrocardiogram, and/or hemoglobinometry prior to randomization.
* Ventilation minute signal, PETCO2 or PETO2 unusable.
* Irreversible deterioration in the volunteer's health during the study period, likely to affect the experimental conditions.

Where it's running

• Poitiers University Hospital
  Poitiers, France Recruiting

Study contacts

• Study coordinator: Vanessa BIRONNEAU, MD
• Email: vanessa.bironneau@chu-poitiers.fr
• Phone: 05 49 44 34 49

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.