An interventional study of Acute Intermittent Hypoxia (AIH) and Normoxic Sham Intervention in Major Depressive Disorder (MDD), sponsored by Capital Medical University. Withdrawn. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Capital Medical University · Not applicable, Interventional, and Treatment
The study was withdrawn before enrollment of the first participant due to changes in the research plan.
The goal of this clinical trial is to evaluate the efficacy of acute intermittent hypoxia for the treatment of patients with major depressive disorder. The study will also assess the safety and tolerability of acute intermittent hypoxia and explore its potential mechanisms underlying its antidepressant effects.
This multicenter, randomized, parallel-group, sham-controlled trial aims to evaluate the efficacy and safety of acute intermittent hypoxia (aIH) in patients with depressive disorders and to investigate its potential mechanisms of action.
A total of 156 participants will be recruited from one lead center (Beijing Anding Hospital) and three participating centers. Participants will be randomly assigned in a 1:1 ratio to aIH or sham intervention using block randomization stratified by study center. Both groups will complete 10 treatment sessions over 2 weeks, followed by a 6-week follow-up period. The aIH intervention will consist of alternating periods of hypoxia and normoxia. An individualized oxygen concentration for hypoxic exposure will be established before treatment based on tolerability and will remain fixed throughout the 10-session treatment course. The sham intervention will be administered under normoxic conditions.
Clinical assessments will be conducted at baseline and at weeks 1, 2, and 8. The primary outcome is the between-group difference in change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 2 (After 10 Treatment Sessions). Exploratory assessments will include hypoxia tolerance testing and functional near-infrared spectroscopy (fNIRS). A subset of participants will undergo additional neurophysiological assessments, brain imaging, magnetoencephalography (MEG), and peripheral blood sampling at selected time points, including baseline, the end of the intervention, and the end of follow-up, to explore potential neurobiological mechanisms underlying the effects of aIH.
One interim analysis of efficacy and safety is planned after approximately half of the participants have completed the primary endpoint assessment. An independent Data Monitoring Committee will review unblinded interim data according to prespecified procedures.
3,046 studies on the registry are indexed under Depressive Disorder, Major; 592 are open to participants now.
Browse Depressive Disorder, Major studies →Capital Medical University is the lead sponsor of 296 studies on the registry; 90 are open to participants now.
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Inclusion Criteria:*
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the acute intermittent hypoxia (aIH) group will receive 10 sessions of acute intermittent hypoxia intervention within 2 weeks. Each session will include intermittent hypoxia-reoxygenation cycles, with a cumulative hypoxic exposure time of 40 minutes per session.The inspired oxygen fraction (FiO₂) used in the hypoxia group will be set according to the tolerated level determined at baseline and kept constant throughout the 10 treatment sessions.
Other: Acute Intermittent Hypoxia (AIH) · Device: Acute Intermittent Hypoxia Delivery Device
Participants in the normoxic sham intervention group will complete a sham oxygen concentration exploration session at baseline, followed by 10 sessions of sham normoxic intervention within 2 weeks. Each session will use the same device, intervention environment, cycle settings, treatment frequency, and session duration as the acute intermittent hypoxia group. Participants will receive normobaric normoxic air throughout the formal intervention, with the inspired oxygen fraction (FiO₂) kept constant at 0.21.
Other: Normoxic Sham Intervention · Device: Acute Intermittent Hypoxia Delivery Device
Participants will receive acute intermittent hypoxia using a study device with built-in safety protections. A brief FIO₂ exploration session will be conducted at baseline to determine an individualized tolerated oxygen level for each participant. This individualized FIO₂ will then be used and kept constant throughout all 10 formal treatment sessions.The 10 sessions will be completed within 2 weeks, with each session including eight hypoxia-reoxygenation cycles totaling 40 minutes of hypoxic exposure.
Participants in the normoxic sham intervention group will complete a brief sham oxygen concentration exploration session at baseline, followed by 10 sessions of sham normoxic intervention within 2 weeks. Each session will use the same device, intervention environment, cycle settings, treatment frequency, and session duration as the acute intermittent hypoxia group. Participants will receive normobaric normoxic air throughout the formal intervention, with the inspired oxygen fraction (FiO₂) kept constant at 0.21.
A computerized device used to deliver acute intermittent hypoxia by precisely controlling inspired oxygen concentration (FiO₂), hypoxia-reoxygenation cycles, treatment duration, and physiological safety monitoring. The device includes built-in safety protections and continuous monitoring throughout treatment.
The same computerized device will be used to deliver normobaric normoxic air (FiO₂ = 0.21) during sham intervention while maintaining identical operating procedures, treatment schedule, cycle settings, physiological monitoring, and safety protections as used in the experimental group
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 2 (After 10 Treatment Sessions)
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to the end of 10 treatment sessions (Week 2) will be compared between the aIH and sham-control groups. The MADRS is a clinician-rated measure of depressive symptom severity, with total scores ranging from 0 to 60. Higher scores indicate more severe depressive symptoms, and a greater reduction from baseline indicates greater improvement.
Time frame: Baseline to the end of 10 treatment sessions (Week 2).
Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate
Proportion of participants with a clinical response, defined as a 50% or greater reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
17-Item Hamilton Depression Rating Scale (HAMD-17) Response Rate
Proportion of participants with a clinical response, defined as a 50% or greater reduction in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score from baseline.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate
Proportion of participants achieving remission, defined as a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 10 or lower.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
17-Item Hamilton Depression Rating Scale (HAMD-17) Remission Rate
Proportion of participants achieving remission, defined as a 17-item Hamilton Depression Rating Scale (HAMD-17) total score of 7 or lower.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Other Assessment Time Points
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to each specified assessment time point. The MADRS total score ranges from 0 to 60, with higher scores indicating more severe depressive symptoms. A greater reduction from baseline indicates greater improvement.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score
Change in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score from baseline to each specified assessment time point. The HAMD-17 is a clinician-rated measure of depressive symptom severity, with total scores ranging from 0 to 52. Higher scores indicate more severe depressive symptoms, and a greater reduction from baseline indicates greater improvement.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in 14-Item Hamilton Anxiety Rating Scale (HAMA-14) Total Score
Change in the 14-item Hamilton Anxiety Rating Scale (HAMA-14) total score from baseline to each specified assessment time point. The HAMA-14 is a clinician-rated measure of anxiety symptom severity, with total scores ranging from 0 to 56. Higher scores indicate more severe anxiety symptoms, and a greater reduction from baseline indicates greater improvement.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score and Clinical Global Impressions-Improvement (CGI-I) Score
The Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I) scales are clinician-rated scales used to assess illness severity and change over time. CGI-S scores range from 1 to 7 (higher scores indicate greater severity), and CGI-I scores range from 1 to 7 (lower scores indicate greater improvement). CGI-S change from baseline will be calculated as baseline minus post-baseline scores, while CGI-I will be assessed at each post-baseline time point.
Time frame: Baseline ; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in 16-Item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) Total Score
Change in the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) total score from baseline to each specified assessment time point. The QIDS-SR16 is a self-report measure of depressive symptom severity, with total scores ranging from 0 to 27. Higher scores indicate more severe depressive symptoms, and a greater reduction from baseline indicates greater improvement.
Time frame: Baseline; after 1 treatment session (Day 1); after 3 treatment sessions (Day 3); after 5 treatment sessions (Week 1); after 7 treatment sessions (Day 9); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score
Change in the Generalized Anxiety Disorder-7 (GAD-7) total score from baseline to each specified assessment time point. The GAD-7 is a 7-item self-report measure of anxiety symptom severity, with total scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms, and a greater reduction from baseline indicates greater improvement.
Time frame: Baseline; after 1 treatment session (Day 1); after 3 treatment sessions (Day 3); after 5 treatment sessions (Week 1); after 7 treatment sessions (Day 9); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Immediate Mood Scale (IMS) Total Score
Change in the Immediate Mood Scale (IMS) total score from baseline to each specified assessment time point. The IMS is a 22-item self-report measure of current mood state, with total scores ranging from -66 to +66. Higher scores indicate better mood, and a greater increase from baseline indicates greater improvement.
Time frame: Baseline; after 1 treatment session (Day 1); after 3 treatment sessions (Day 3); after 5 treatment sessions (Week 1); after 7 treatment sessions (Day 9); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Lake Louise Score (LLS) Total Score
Change in the Lake Louise Score (LLS) total score from baseline to each specified assessment time point. The LLS is a 4-item self-report measure covering headache, gastrointestinal symptoms, fatigue/weakness, and dizziness/lightheadedness. Total scores range from 0 to 12, with higher scores indicating greater symptom severity. An increase from baseline indicates worsening symptoms.
Time frame: Baseline; after 1 treatment session (Day 1); after 3 treatment sessions (Day 3); after 5 treatment sessions (Week 1); after 7 treatment sessions (Day 9); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in 10-Item Perceived Stress Scale (PSS-10) Total Score
Change in the 10-item Perceived Stress Scale (PSS-10) total score from baseline to each specified assessment time point. The PSS-10 is a self-report measure of perceived stress, with total scores ranging from 0 to 40. Higher scores indicate greater perceived stress, and a greater reduction from baseline indicates greater improvement.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Sheehan Disability Scale (SDS) Total Score
Change in the Sheehan Disability Scale (SDS) total score from baseline to each specified assessment time point. The SDS is a self-report measure of functional impairment in three domains: work/school, social life, and family life/home responsibilities. Total scores range from 0 to 30, with higher scores indicating greater functional impairment. A greater reduction from baseline indicates greater improvement.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in The Digit Symbol Substitution Test (DSST) Score
The Digit Symbol Substitution Test (DSST) is an assessor-administered neuropsychological test used to assess cognitive processing speed, attention, and visuomotor coordination. The DSST score is defined as the number of correctly completed digit-symbol substitutions within 90 seconds. Change from baseline will be calculated as the DSST score at each post-baseline assessment minus the baseline DSST score. A positive change from baseline indicates improvement in cognitive processing speed, attention, and visuomotor performance Unit of Measure: Points
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Digit Span Test (DST) Score
Change in the Digit Span Test (DST) score from baseline to each specified assessment time point. The DST assesses attention and working memory through forward and backward digit recall tasks. Higher scores indicate better performance, and an increase from baseline indicates improvement.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Insomnia Severity Index (ISI) Total Score
Change in the Insomnia Severity Index (ISI) total score from baseline to each specified assessment time point. The ISI is a 7-item self-report measure of insomnia severity, with total scores ranging from 0 to 28. Higher scores indicate more severe insomnia, and a greater reduction from baseline indicates greater improvement.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8)
Incidence of Adverse Events and Serious Adverse Events
All adverse events (AEs) and serious adverse event (SAE) occurring during the study will be collected and recorded, including their type, severity, duration, and relationship to acute intermittent hypoxia treatment.
Time frame: Baseline; after each treatment session and Week 8.
Change From Baseline in Chinese Version of the Stanford Expectations of Treatment Scale (C-SETS) Subscale Scores
Change in the Positive Expectancy and Negative Expectancy subscale scores of the Chinese version of the Stanford Expectations of Treatment Scale (C-SETS) from baseline to each specified assessment time point. The C-SETS is a 6-item self-report measure of treatment expectations. Each subscale comprises three items and has a summed score ranging from 3 to 21. Higher Positive Expectancy scores indicate greater positive treatment expectations, whereas higher Negative Expectancy scores indicate greater negative treatment expectations. Changes in the two subscales will be evaluated separately.
Time frame: Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) Total Score
Change in the Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) total score from baseline to each specified assessment time point. The BRIAN is a clinician-administered measure of biological rhythm disturbances covering sleep, activity, social rhythms, and eating patterns. The 18-item total score ranges from 18 to 72. Higher scores indicate greater biological rhythm disturbances, and a greater reduction from baseline indicates greater improvement.
Time frame: Baseline; after 5 treatment sessions (Week 1) and after 10 treatment sessions (Week 2).
Life Events Scale (LES) Score at Baseline
The Life Events Scale (LES) will be administered at baseline to assess exposure to stressful life events and their perceived impact. Higher scores indicate a greater burden of life event-related stress.
Time frame: Baseline (before treatment).
Change in Resting-State electroencephalography (EEG) Spectral Power
Resting-state electroencephalography (EEG) will be used to assess spectral power in predefined frequency bands, including delta (\<4 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (14-25 Hz), and low-gamma (25-50 Hz). The theta/beta power ratio will also be calculated. Changes from baseline in these EEG measures will be assessed at each post-baseline assessment.
Time frame: Baseline; after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Resting-State Electroencephalography (EEG) Functional Connectivity
Change in resting-state electroencephalography (EEG)-derived functional connectivity from baseline to the end of the intervention. Functional connectivity measures across prespecified frequency bands will be evaluated to explore treatment-related changes in brain functional networks.
Time frame: Baseline; after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Cerebral Hemodynamic Parameters Assessed by Functional Near-Infrared Spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) will be used to assess oxyhemoglobin (HbO), deoxyhemoglobin (HbR), and total hemoglobin (HbT) concentration changes in prespecified cortical regions. HbT will be calculated as the sum of HbO and HbR. Changes from baseline in these parameters and prespecified derived hemodynamic measures will be evaluated at each post-baseline assessment.
Time frame: Baseline; after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Brain Activation and Functional Connectivity Assessed by Functional Near-Infrared Spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) will be used to assess task-related brain activation and resting-state functional connectivity. Task-related activation will be quantified using beta coefficients or activation amplitudes in prespecified channels or regions of interest. Resting-state functional connectivity will be quantified using Pearson correlation coefficients between channel pairs. Changes from baseline in these measures will be evaluated at each post-baseline assessment to explore the neurofunctional effects of aIH.
Time frame: Baseline; after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8).
Change From Baseline in Salivary Cortisol Levels
Salivary cortisol will be assessed at baseline and after 10 treatment sessions. At each assessment, saliva samples will be collected at five time points: 4:00 PM, before bedtime, upon awakening, 30 minutes after awakening, and 60 minutes after awakening. Cortisol concentrations in the saliva samples will be analyzed. The outcome is the change in salivary cortisol levels from baseline to after 10 treatment sessions at each sampling time point.
Time frame: Baseline and after 10 treatment sessions (Week 2).
Change From Baseline in Peripheral Blood Adenosine-Related Metabolite Profile
Peripheral blood samples will be analyzed to quantify a prespecified panel of metabolites involved in adenosine synthesis, metabolism, and degradation, including adenosine and related upstream and downstream metabolites in the purine metabolic pathway. Changes from baseline in these metabolites will be evaluated to characterize treatment-related alterations in peripheral adenosine metabolism.
Time frame: Baseline and after 10 treatment sessions (Week 2).
Change From Baseline in Peripheral Blood Multi-Omics Profiles
Peripheral blood samples will be analyzed to explore treatment-related molecular changes in biological pathways potentially involved in the effects of acute intermittent hypoxia therapy. Exploratory analyses may include metabolomic, proteomic, transcriptomic, and epigenomic profiling, including DNA methylation analysis, with particular attention to pathways related to adenosine and purine metabolism, neuroplasticity, inflammation, stress regulation, and other relevant biological processes. The primary molecular comparison will evaluate changes from baseline to the end of treatment after completion of 10 treatment sessions.
Time frame: Baseline and after 10 treatment sessions (Week 2).
Change From Baseline in Resting-State Magnetoencephalography (MEG) Measures
Resting-state MEG data will be collected at baseline and after 10 treatment sessions using a 128-channel optically pumped magnetometer (OPM)-based MEG system (Marvel MEG 128; Unimagtech, Beijing, China) at a sampling rate of 1,000 Hz. Participants will lie supine with their heads positioned within the OPM sensor array and will be instructed to remain as still as possible and not fall asleep. Resting-state recordings will include two conditions: eyes closed and eyes open while fixating on a cross. Each condition will last 5 minutes. The total OPM-MEG acquisition time will be approximately 35 minutes, including resting-state and task-based recordings. The outcome is the change in the prespecified resting-state MEG measure(s) from baseline to after 10 treatment sessions.
Time frame: Baseline and after 10 treatment sessions (Week 2).
Change From Baseline in Brain Function Assessed by Functional Magnetic Resonance Imaging (fMRI)
Functional magnetic resonance imaging (fMRI) will be used to assess treatment-related changes in resting-state brain function and task-evoked brain activation. Resting-state measures may include the amplitude or fractional amplitude of low-frequency fluctuations, regional homogeneity, and functional connectivity within and between predefined brain regions and functional networks. Task-evoked activation will be assessed during the \[exact task name\] and quantified using changes in blood oxygen level-dependent (BOLD) signals in predefined brain regions. Changes from baseline to the end of treatment will be evaluated to characterize alterations in spontaneous brain activity, functional network organization, and task-related cortical activation associated with acute intermittent hypoxia therapy.
Time frame: Baseline and after 10 treatment sessions (Week 2).
Change From Baseline in Brain Structure Assessed by Structural Magnetic Resonance Imaging (MRI)
High-resolution structural magnetic resonance imaging will be used to assess treatment-related changes in brain structure. Prespecified measures may include cortical thickness, regional gray matter volume, and subcortical volume in predefined brain regions. Changes from baseline to the end of treatment will be evaluated to characterize structural brain alterations associated with acute intermittent hypoxia therapy.
Time frame: Baseline and after 10 treatment sessions (Week 2).
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2028, 17 months later.
How these figures are worked out, and which studies are left out of them.
The study was withdrawn before enrollment of the first participant due to changes in the research plan.
The study was withdrawn before enrollment of the first participant due to changes in the research plan.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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