NCT07516028

Brief Summary

Hypoxia, defined as a reduction in the availability of oxygen, induces significant physiological adaptations. While the deleterious effects of severe and chronic hypoxia are well documented, several studies indicate that moderate hypoxia - particularly when administered intermittently - may produce beneficial effects on cardiometabolic health (e.g., improved regulation of blood pressure and better glycaemic control). However, its impact on the dynamics of brain circuits in humans remains relatively underexplored. The present project aims to characterise the effects of continuous and intermittent moderate hypoxia on resting-state brain dynamics in healthy adults. To this end, simultaneous electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) recordings will be conducted in order to extract functional and haemodynamic markers of brain activity. This project will contribute to a better understanding of the neurophysiological mechanisms associated with hypoxic conditioning and to the assessment of its potential application in innovative therapeutic approaches.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress73%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

March 5, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

March 5, 2026

Last Update Submit

September 16, 2026

Conditions

Keywords

hypoxiaeegfnirsmotor-evoked potentialstms

Outcome Measures

Primary Outcomes (2)

  • Electrical brain activity

    Electroencephalography (EEG) data will be recorded using a SAGA system (TMSi, Einsteinweg, The Netherlands). This system includes 64 Ag/AgCl pin-type electrodes. An additional electrode will be positioned on either the left or right mastoid. The primary outcome will be the variation in spectral power within the alpha frequency band.

    Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.

  • Haemodynamic activity

    A Brite system (Artinis, Einsteinweg, The Netherlands) will be used to collect functional near-infrared spectroscopy (fNIRS) data. The equipment comprises four LED emitters and four photodiode receivers. A nine-channel montage will be designed to cover the regions of interest, namely the dorsolateral prefrontal cortex, the ventromedial prefrontal cortex, and the anterior prefrontal cortex. The primary outcome will be the variation in deoxyhaemoglobin (HbR).

    Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.

Secondary Outcomes (3)

  • Corticospinal excitability

    Assessed at baseline and immediately post-intervention during each of the three experimental sessions (i.e., intermittent moderate hypoxia, continuous moderate hypoxia, normoxia).

  • EEG brain connectivity

    Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.

  • fNIRS brain connectivity

    Assessed throughout the intervention, at Day 2, 3, and 4 of the protocol.

Study Arms (3)

Normoxia

SHAM COMPARATOR

The sham condition will consist of 30 minutes of continuous exposure to ambient air, inhaled through the same mask as that used during the hypoxia conditions.

Device: NormoxiaDevice: Transcranial Magnetic Stimulation

Continuous moderate hypoxia

EXPERIMENTAL

The duration of exposure to continuous hypoxia will be 30 minutes. A peripheral oxygen saturation (SpO₂) between 85% and 90% will be targeted. Hypoxic exposure will take place at rest, with the participant comfortably seated. In addition, the hypoxic device used in the study is equipped with a safety system allowing a minimum fraction of inspired oxygen (FiO₂) to be defined. This threshold will be set at 10%, ensuring that the FiO₂ cannot fall below this value.

Device: Moderate hypoxiaDevice: Transcranial Magnetic Stimulation

Intermittent moderate hypoxia

EXPERIMENTAL

The intermittent hypoxia condition will consist of six periods of 5 minutes of hypoxia interspersed with 5-minute periods of normoxia. During the hypoxic periods, a SpO₂ between 85% and 90% will be targeted. As in the continuous condition, hypoxic exposure will take place at rest, with the participant comfortably seated. The hypoxic device also includes a safety system allowing a minimum FiO₂ to be defined; this threshold will be set at 10%, ensuring that the FiO₂ cannot fall below this value.

Device: Moderate hypoxiaDevice: Transcranial Magnetic Stimulation

Interventions

Altitude conditions (normobaric hypoxia) will be reproduced using the OnePlus VA device (GO2Altitude, Biomedtech, Melbourne, Australia). This device modulates the fraction of inspired oxygen (FiO₂) through a patented semi-permeable membrane system developed by the company. It thereby produces a gas mixture that is inhaled by the participant through a mask. This device included an oxygen-reduction algorithm, that adjusts the FiO₂ in real time according to a target peripheral oxygen saturation (SpO₂ = 85-90%).

Continuous moderate hypoxiaIntermittent moderate hypoxia
NormoxiaDEVICE

Ambient air will be delivered through the same mask as that used during the hypoxia conditions.

Normoxia

Single- and paired-pulse TMS will be applied over the primary motor cortex (M1) to assess corticospinal excitability, along with intracortical inhibitory and facilitatory mechanisms. Motor-evoked potentials will be recorded from the abductor pollicis brevis (APB) muscle of the dominant hand.

Also known as: TMS
Continuous moderate hypoxiaIntermittent moderate hypoxiaNormoxia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18 to 65 years
  • Healthy right- or left-handed individuals with no self-reported neurological disorders or history of neurological conditions (e.g., epilepsy, stroke, brain or spinal surgery, or neurological diseases affecting motor or sensory function such as multiple sclerosis, or neurodegenerative diseases such as Parkinson's or Alzheimer's)
  • Individuals who have provided informed consent and have sufficient proficiency in French
  • Participants affiliated with, or beneficiaries of, a social security scheme

You may not qualify if:

  • Body mass index (BMI) greater than 30 kg/m²
  • Diagnosed and untreated obstructive sleep apnoea syndrome
  • Inability to provide informed consent
  • History of cardiac (e.g., ischaemic heart disease, heart failure) and/or respiratory disorders (e.g., COPD, chronic respiratory insufficiency, persistent or uncontrolled asthma)
  • Current smokers
  • Contraindications to TMS (e.g., uncontrolled epilepsy, intracranial metallic foreign body, hearing aid or cochlear implant, implanted stimulator or pump, scalp lesions, elevated intracranial pressure, cerebrospinal fluid shunt)
  • Use of psychotropic medication
  • Individuals under legal guardianship or curatorship
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurasport

Loos, Hauts-de-France, 59120, France

RECRUITING

MeSH Terms

Conditions

Hypoxia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Ségolène M. R. Guérin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2026

First Posted

April 7, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations