HypoxiaNCT07018817
Hypoxia Adaptation Promotes Cerebral Functional Connectivity With Neuromuscular Efficiency Decrement
An observational study of Hypoxia and Altitude Sickness, run by Peking Union Medical College at 1 site in China.
Trial summary
The study utilized a trimodal setup comprising EEG, EMG, and fNIRS modules. Participants wore a 64-channel dry EEG cap, while EMG electrodes were placed on the right biceps brachii, the flexor digitorum profundus of the forearm, and the gastrocnemius muscle. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Altitude Sickness
- What is being tested?
- motor execution motor imagery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2023to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Short-term migration from the highlands
Who may be able to join
- People who can withstand altitude sickness
Who cannot join
- Plateau Native
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Biomedical engineering，Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, 300000
About this study
Official title: A Trimodal Study on Hypoxia Adaptation: Promotion of Cerebral Functional Connectivity and Decrement of Neuromuscular Efficiency
The study utilized a trimodal setup comprising EEG, EMG, and fNIRS modules. Participants wore a 64-channel dry EEG cap, while EMG electrodes were placed on the right biceps brachii, the flexor digitorum profundus of the forearm, and the gastrocnemius muscle. fNIRS probes were positioned on the forehead to monitor cerebral hemodynamic responses.
The experimental paradigm included two tasks: motor execution (ME) and motor imagery (MI). During ME, participants performed 15 trials of actual movements. In MI, participants completed 60 trials of imagined movements. Each trial involved a randomly presented stimulus-left-hand clenching, right-hand clenching, or bilateral heel raising-with each movement type occurring an equal number of times across the session.
Read the detailed description
This study employed a multimodal acquisition system comprising EEG, EMG, and fNIRS modules. Participants were fitted with a 64-channel dry EEG cap for the measurement of cortical electrical activity. Surface EMG electrodes were attached to three muscle groups: the right biceps brachii, the flexor digitorum profundus of the forearm, and the gastrocnemius muscle, to record muscle activation signals. Simultaneously, fNIRS probes were positioned on the participants' foreheads to monitor cerebral hemodynamic responses.
The experimental paradigm was divided into two tasks: motor execution (ME) and motor imagery (MI). During the ME task, participants performed 15 trials of actual movements, whereas the MI task involved 60 trials of imagined movements. Each trial randomly presented one of three stimuli-left-hand clenching, right-hand clenching, or bilateral heel raising-with an equal distribution of the three movement types across the session. The order of stimuli was randomized to prevent prediction bias.
- Conditions
- Hypoxia, Altitude Sickness
- Being tested
- motor execution motor imagery
- Keywords
- Brain
- Medical subject headings
- Hypoxia, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor execution motor imageryBehavioural
Participants will perform motor execution tasks and motor imagery tasks following standardized instructions under controlled conditions.
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Power Spectrum in Motor Imagery and Motor Execution Tasks
Measured: up to 2 weeks
Secondary outcomes (2)
Surface EMG Amplitude of Upper Limb Muscles during Motor Tasks
Measured: up to 2 weeks
Cerebral Oxygenation Measured by Near-Infrared Spectroscopy (NIRS) in Prefrontal Cortex
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start15 Jul 2023
- Primary completion23 Aug 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, T.Li, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018817
- Sponsor's protocol ID
- Brain Adaptation to Hypoxia
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trimodal Study on Hypoxia Adaptation: Promotion of Cerebral Functional Connectivity and Decrement of Neuromuscular Efficiency
- ClinicalTrials.gov ID
- NCT07018817
- Acronym / sponsor ID
- Brain Adaptation to Hypoxia
- Conditions
- Hypoxia, Altitude Sickness
- Keywords
- Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study utilized a trimodal setup comprising EEG, EMG, and fNIRS modules. Participants wore a 64-channel dry EEG cap, while EMG electrodes were placed on the right biceps brachii, the flexor digitorum profundus of the forearm, and the gastrocnemius muscle. fNIRS probes were positioned on the forehead to monitor cerebral hemodynamic responses.
The experimental paradigm included two tasks: motor execution (ME) and motor imagery (MI). During ME, participants performed 15 trials of actual movements. In MI, participants completed 60 trials of imagined movements. Each trial involved a randomly presented stimulus-left-hand clenching, right-hand clenching, or bilateral heel raising-with each movement type occurring an equal number of times across the session.
Detailed description
This study employed a multimodal acquisition system comprising EEG, EMG, and fNIRS modules. Participants were fitted with a 64-channel dry EEG cap for the measurement of cortical electrical activity. Surface EMG electrodes were attached to three muscle groups: the right biceps brachii, the flexor digitorum profundus of the forearm, and the gastrocnemius muscle, to record muscle activation signals. Simultaneously, fNIRS probes were positioned on the participants' foreheads to monitor cerebral hemodynamic responses.
The experimental paradigm was divided into two tasks: motor execution (ME) and motor imagery (MI). During the ME task, participants performed 15 trials of actual movements, whereas the MI task involved 60 trials of imagined movements. Each trial randomly presented one of three stimuli-left-hand clenching, right-hand clenching, or bilateral heel raising-with an equal distribution of the three movement types across the session. The order of stimuli was randomized to prevent prediction bias.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Short-term migration from the highlands
Key inclusion criteria (1 listed)
- People who can withstand altitude sickness
Key exclusion criteria (1 listed)
- Plateau Native
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motor execution motor imageryParticipants will perform motor execution tasks and motor imagery tasks following standardized instructions under controlled conditions. | Behavioural | – |
Primary outcome
EEG Power Spectrum in Motor Imagery and Motor Execution Tasks
Time frame: up to 2 weeks
2 secondary outcomes
Surface EMG Amplitude of Upper Limb Muscles during Motor Tasks
Time frame: up to 2 weeks
Cerebral Oxygenation Measured by Near-Infrared Spectroscopy (NIRS) in Prefrontal Cortex
Time frame: up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Hypoxia
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia and Altitude Sickness, run by Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG Power Spectrum in Motor Imagery and Motor Execution Tasks (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.