Brain Connectivity and Corticospinal Excitability in Response to Moderate Hypoxia
NEUROXIE
1 other identifier
interventional
36
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
March 5, 2026
CompletedStudy Start
First participant enrolled
March 15, 2026
CompletedFirst Posted
Study publicly available on registry
April 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 20, 2026
September 21, 2026
September 1, 2026
9 months
March 5, 2026
September 16, 2026
Conditions
Keywords
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 COMPARATORThe 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.
Continuous moderate hypoxia
EXPERIMENTALThe 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.
Intermittent moderate hypoxia
EXPERIMENTALThe 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.
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%).
Ambient air will be delivered through the same mask as that used during the hypoxia conditions.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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