Major Depressive Disorder (MDD)NCT07921654
Acute Intermittent Hypoxia Therapy for Depression
A study testing Acute Intermittent Hypoxia (AIH) and Acute Intermittent Hypoxia Delivery Device in people with Major Depressive Disorder (MDD), run by Capital Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Acute Intermittent Hypoxia (AIH) and Acute Intermittent Hypoxia Delivery Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Outpatients or inpatients aged 18 to 45 years, inclusive, of any sex.
- Current episode meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for first-episode or recurrent major depressive disorder, without psychotic features during the current episode.
- Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥22 at both screening and baseline.
- No current use of antidepressants, antipsychotics, or mood stabilizers. Participants with prior use must have completed an adequate washout period before enrollment: at least 5 drug half-lives, or at least 28 days for fluoxetine.
- Long-term residence in a low-altitude plain area and no travel to areas above 1,500 meters in altitude within the past 30 days.
- Education level above primary school and ability to understand the contents of the study scales.
- Written informed consent provided by the participant.
Who cannot join
- Current or previous diagnosis, according to DSM-5 criteria, of neurodevelopmental disorders, neurocognitive disorders, bipolar disorder, schizophrenia spectrum and other psychotic disorders, or substance-related and addictive disorders.
- Score ≥4 on item 10 of the MADRS suicide item.
- Presence of neurological diseases, such as epilepsy, cerebrovascular disease, intracranial infectious disease, demyelinating disease, cerebral edema, or other severe neurological disorders.
- History of chest tightness or chest pain.
- Severe cardiovascular disease, such as severe hypertension, arrhythmia, coronary heart disease, mitral stenosis, atrial fibrillation, myocardial infarction, intracardiac mural thrombus or valvular vegetation, congestive heart failure, or endocarditis.
- Respiratory disease, such as sleep apnea, asthma, chronic obstructive pulmonary disease, or pulmonary edema.
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- Severe hepatic or renal insufficiency, malignant tumor, or other severe disease requiring medical intervention or surgery.
- Severe thyroid dysfunction.
- Significant coagulation abnormalities or severe hematologic disease.
- Current need for oxygen therapy or other treatment to improve systemic oxygenation.
- Participation in another clinical trial within the past 3 months.
- Subjects who have received neuromodulation treatment, MECT, or systematic psychotherapy within the past 3 months.
- Pregnant or breastfeeding women, or participants who are unable to use appropriate contraception during the study.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for this study.
About this study
Official title: Efficacy and Safety of Acute Intermittent Hypoxia Therapy for Major Depressive Disorder: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Acute Intermittent Hypoxia (AIH), Normoxic Sham Intervention, Acute Intermittent Hypoxia Delivery Device
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Intermittent Hypoxia (AIH)Other
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.
Normoxic Sham InterventionOther
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.
Acute Intermittent Hypoxia Delivery DeviceDevice
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.
Acute Intermittent Hypoxia Delivery DeviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Acute Intermittent Hypoxia Group | Experimental | 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. Receives: Other: Acute Intermittent Hypoxia (AIH); Device: Acute Intermittent Hypoxia Delivery Device |
| Normoxic Sham Intervention Group | Sham comparator | 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. Receives: Other: Normoxic Sham Intervention; Device: Acute Intermittent Hypoxia Delivery Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to the end of 10 treatment sessions (Week 2).
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; after each treatment session and Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Institute for Brain Research
- Responsible party
- Principal investigator, Gang Wang, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921654
- Sponsor's protocol ID
- 2026-22
- Status last verified
- Nov 2026
- First submitted
- 10 Jun 2026
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Acute Intermittent Hypoxia Therapy for Major Depressive Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07921654
- Acronym / sponsor ID
- 2026-22
- Conditions
- Major Depressive Disorder (MDD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese Institute for Brain Research
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Nov 2026 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Intermittent Hypoxia Group | Experimental | Other: Acute Intermittent Hypoxia (AIH), Device: Acute Intermittent Hypoxia Delivery DeviceParticipants 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. |
| Normoxic Sham Intervention Group | Sham comparator | Other: Normoxic Sham Intervention, Device: Acute Intermittent Hypoxia Delivery DeviceParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Outpatients or inpatients aged 18 to 45 years, inclusive, of any sex.
- Current episode meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for first-episode or recurrent major depressive disorder, without psychotic features during the current episode.
- Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥22 at both screening and baseline.
- No current use of antidepressants, antipsychotics, or mood stabilizers. Participants with prior use must have completed an adequate washout period before enrollment: at least 5 drug half-lives, or at least 28 days for fluoxetine.
- Long-term residence in a low-altitude plain area and no travel to areas above 1,500 meters in altitude within the past 30 days.
Key exclusion criteria (14 listed)
- Current or previous diagnosis, according to DSM-5 criteria, of neurodevelopmental disorders, neurocognitive disorders, bipolar disorder, schizophrenia spectrum and other psychotic disorders, or substance-related and addictive disorders.
- Score ≥4 on item 10 of the MADRS suicide item.
- Presence of neurological diseases, such as epilepsy, cerebrovascular disease, intracranial infectious disease, demyelinating disease, cerebral edema, or other severe neurological disorders.
- History of chest tightness or chest pain.
- Severe cardiovascular disease, such as severe hypertension, arrhythmia, coronary heart disease, mitral stenosis, atrial fibrillation, myocardial infarction, intracardiac mural thrombus or valvular vegetation, congestive heart failure, or endocarditis.
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 |
|---|---|---|
| Acute Intermittent Hypoxia (AIH)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. | Other | Acute Intermittent Hypoxia Group |
| Normoxic Sham InterventionParticipants 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. | Other | Normoxic Sham Intervention Group |
| Acute Intermittent Hypoxia Delivery DeviceA 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. | Device | Acute Intermittent Hypoxia Group |
| Acute Intermittent Hypoxia Delivery DeviceThe 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 | Device | Normoxic Sham Intervention Group |
Primary outcome
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 2 (After 10 Treatment Sessions)
Time frame: Baseline to the end of 10 treatment sessions (Week 2).
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.
18 secondary outcomes
Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Baseline; after each treatment session and Week 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
Active, not recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Depression, MDD
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Intermittent Hypoxia (AIH) and Acute Intermittent Hypoxia Delivery Device in people with Major Depressive Disorder (MDD), run by Capital Medical University.
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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 2 (After 10 Treatment Sessions) (time frame: Baseline to the end of 10 treatment sessions (Week 2).). 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 6 Nov 2026.