Acute Intermittent Hypoxia Therapy for Depression
NCT07921654, Not applicable, Withdrawn, Capital Medical University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Acute Intermittent Hypoxia Therapy for Depression | ClinicalTrials.gov |
| NCT number | NCT07921654 | ClinicalTrials.gov |
| Status | Withdrawn | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 0 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Capital Medical University | ClinicalTrials.gov |
| Conditions | Major Depressive Disorder (MDD) | ClinicalTrials.gov |
| Interventions | Acute Intermittent Hypoxia (AIH), Normoxic Sham Intervention, Acute Intermittent Hypoxia Delivery Device, Acute Intermittent Hypoxia Delivery Device | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 2 (After 10 Treatment Sessions) | 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. | ClinicalTrials.gov |
| Secondary | Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | 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. | ClinicalTrials.gov |
| Secondary | 17-Item Hamilton Depression Rating Scale (HAMD-17) Response Rate | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | 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. | ClinicalTrials.gov |
| Secondary | Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | Proportion of participants achieving remission, defined as a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 10 or lower. | ClinicalTrials.gov |
| Secondary | 17-Item Hamilton Depression Rating Scale (HAMD-17) Remission Rate | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | Proportion of participants achieving remission, defined as a 17-item Hamilton Depression Rating Scale (HAMD-17) total score of 7 or lower. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Other Assessment Time Points | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in 14-Item Hamilton Anxiety Rating Scale (HAMA-14) Total Score | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score and Clinical Global Impressions-Improvement (CGI-I) Score | Baseline ; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in 16-Item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) Total Score | 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 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score | 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 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Immediate Mood Scale (IMS) Total Score | 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 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Lake Louise Score (LLS) Total Score | 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 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in 10-Item Perceived Stress Scale (PSS-10) Total Score | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Total Score | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in The Digit Symbol Substitution Test (DSST) Score | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | 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 | ClinicalTrials.gov |
| Secondary | Change From Baseline in Digit Span Test (DST) Score | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Insomnia Severity Index (ISI) Total Score | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8) | 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. | ClinicalTrials.gov |
| Secondary | Incidence of Adverse Events and Serious Adverse Events | Baseline; after each treatment session and Week 8. | 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. | ClinicalTrials.gov |
| Other | Change From Baseline in Chinese Version of the Stanford Expectations of Treatment Scale (C-SETS) Subscale Scores | Baseline; after 5 treatment sessions (Week 1); after 10 treatment sessions (Week 2); and at the end of follow-up (Week 8). | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)