NCT07409649

Brief Summary

Sleep apnoea-hypopnoea syndrome (SAHOS), which causes numerous comorbidities, particularly cardiovascular ones, is widespread worldwide today and incurs significant healthcare costs. Current research in this field focuses on identifying different phenotypes in affected patients in order to provide more personalised treatment. One of these phenotypes appears to be linked to instability in ventilatory control due to an increase in loop gain (LG) in these subjects. However, the pathophysiology of this ventilatory control instability due to increased LG is not fully understood. It is still difficult to determine whether subjects have an intrinsically high LG or if exposure to intermittent hypoxia during OSA promotes an increase in LG. It has also been demonstrated that OSA causes vascular hyperreactivity by increasing oxidative stress through elevated ROS production. This leads to endothelial dysfunction in response to intermittent hypoxia associated with apnoea. Extracellular vesicles (microvesicles and exosomes) have been shown to play a role in this endothelial response. These extracellular vesicles are essential for intercellular communication in both physiological and pathological situations, such as SAHOS. Therefore, the objective of this research is to determine whether exposure to intermittent hypoxia and changes in microvesicle phenotype could influence LG, which could lead to new therapeutic advances in the context of SAHOS.

Trial Health

63
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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Mar 2026May 2027

First Submitted

Initial submission to the registry

February 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

February 6, 2026

Last Update Submit

February 12, 2026

Conditions

Intermittent HypoxiaHealthy Volunteers

Keywords

loop gain

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effect of intermittent hypoxia for 6 hours on the evolution of Loop Gain

    Loop gain is the product of 'controller gain' (ventilatory responsiveness to CO₂ above eupnoea) and 'plant gain' (the ventilatory increase required for a given reduction in PaCO₂). Loop gain will be measured before (30 minutes of rest following the participant's arrival) and after (20 minutes before the end of the hypoxia chamber session) the test or control condition (intermittent hypoxia or ambient air). The following ventilatory parameters will be measured using a gas exchange measuring device to calculate loop gain, plant gain and controller gain: * PETCO₂ in mmHg * PETO₂ in mmHg * Minute ventilation (VE), measured in mL/min (tidal volume x respiratory rate). The focus will be on the average loop gain value measured over spontaneous breathing cycles of five to ten minutes. The evaluation criterion will be the difference in the average loop gain value before and after the experimental conditioning (i.e. observation of the change).

    through study completion (visit 1 and visit 2), an average of 14 months

Secondary Outcomes (4)

  • To compare the evolution of controller gain and plant gain between experimental conditions in hypoxia and ambient air

    through study completion (visit 1 and visit 2), an average of 14 months

  • To compare the change in the quantity of extracellular vesicles between experimental conditions in hypoxia and ambient air.

    through study completion (visit 1 and visit 2), an average of 14 months

  • To assess whether changes in the quantity of extracellular vesicles (and microvesicles) correlate with changes in loop gain, both under experimental conditions in hypoxia and under experimental conditions in ambient air.

    through study completion (visit 1 and visit 2), an average of 14 months

  • To compare changes in loop gain between experimental conditions in hypoxia and ambient air, on the one hand in the subgroup of patients with hyperventilation syndrome and on the other hand in the subgroup of patients without hyperventilation syndrome.

    through study completion (visit 1 and visit 2), an average of 14 months

Study Arms (2)

Arm A : ambient air then intermittent hypoxia

EXPERIMENTAL

T1 : Conduct the experiment in ambient air (without hypoxia) for six hours. T2 : Then, after a washout period of at least seven days, conduct the experiment in intermittent hypoxia via the hypoxia chamber for six hours.

Procedure: Intermittent hypoxiaProcedure: Normoxia

Arm B : intermittent hypoxia then ambient air

EXPERIMENTAL

T1 : Conduct an experiment involving intermittent hypoxia in the hypoxia chamber for six hours. T2 : Then, after a washout period of at least seven days, conduct an experiment involving ambient air (without hypoxia).

Procedure: Intermittent hypoxiaProcedure: Normoxia

Interventions

Intermittent hypoxiaPROCEDURE

The volunteer will remain at rest in the hypoxic chamber, experiencing intermittent hypoxic conditions cyclically every 6 minutes. During one third of the cycle, they will be exposed to hypoxia in order to reduce SpO₂ to between 85% and 90%. Then, during two thirds of the cycle, they will receive oxygenation at a rate of 1 L/min (with possible subject-dependent modulations), with the aim of achieving an SpO₂ of greater than 95%. To make the hypoxia intermittent, the volunteer will also be given a medium-concentration oxygen mask that provides intermittent airflow, controlled by the D-6341 mass flow controller.

Arm A : ambient air then intermittent hypoxiaArm B : intermittent hypoxia then ambient air
NormoxiaPROCEDURE

The participant will remain at rest in the hypoxic chamber under normoxic conditions. To prevent the volunteer from becoming aware of the conditions to which they are exposed, an air flow rate of 1 L/min will be used to simulate intermittent oxygenation.

Arm A : ambient air then intermittent hypoxiaArm B : intermittent hypoxia then ambient air

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poitiers University Hospital

Poitiers, 86000, France

Location

Central Study Contacts

Vanessa BIRONNEAU, MD

CONTACT

05 49 44 34 49vanessa.bironneau@chu-poitiers.fr

Celine ABONNEAU, Project manager

CONTACT

05 16 60 42 33celine.abonneau@chu-poitiers.fr

Study Design

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

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 13, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

FR(1)