Trial · NCT04799782
Role of Mirtazapine in Ameliorating Sleep Disordered Breathing
NCT04799782, Phase 2, Completed, Wayne State University; results first posted 2021-04-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Role of Mirtazapine in Ameliorating Sleep Disordered Breathing. Trials, record NCT04799782. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04799782
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Role of Mirtazapine in Ameliorating Sleep Disordered Breathing
- NCT number
- NCT04799782
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Wayne State University
- Conditions
- Spinal Cord Injuries, Sleep Disordered Breathing
- Interventions
- Mirtazapine, Placebo
- First posted
- 2021-03-16
- Last updated
- 2021-06-15
- Results first posted
- 2021-04-20
- Limitations and caveats
* The sample size is small and the majority are males, therefore findings from this study may not be applicable to the general population~* The study required heavy instrumentation which may have affected natural sleep
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CO2 Reserve (Delta-PETCO2-AT) | One Week | Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a physiological sleep study was performed to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold. (2) Cross over medication for one week was followed by a second physiological sleep study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold. |
| Secondary | AHI (Apnea/Hypopnea Index) | One Week | AHI is an index that measures the severity of sleep apnea and is calculated by dividing the total number of apneas and hypopneas by the number of hours of sleep. Randomized placebo-controlled cross-over study. Each subject was studied on two separate occasions: (1) Mirtazapine vs. placebo for one week; After the one-week treatment a polysomnogram (PSG) study was performed to determine the AHI. (2) Cross over medication for one week was followed by a second PSG to determine the AHI. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | CO2 Reserve (Delta-PETCO2-AT) | One Week | Only 10 of the 15 enrolled participants finished both medication arms (placebo, mirtazapine) and were used in the final analysis. | mmHg | MEAN |
| SECONDARY | AHI (Apnea/Hypopnea Index) | One Week | Only 10 of the 15 enrolled participants finished both medication arms (placebo, mirtazapine) and were used in the final analysis. | Events/Hour | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| CO2 Reserve (Delta-PETCO2-AT) | Mirtazapine | -3.8 | Standard Deviation 1.2 | mmHg | |
| CO2 Reserve (Delta-PETCO2-AT) | Placebo | -2.0 | Standard Deviation 1.5 | mmHg | |
| AHI (Apnea/Hypopnea Index) | Mirtazapine | 46.4 | Standard Deviation 22.5 | Events/Hour | |
| AHI (Apnea/Hypopnea Index) | Placebo | 47.8 | Standard Deviation 20.6 | Events/Hour |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Placebo->Mirtazapine | 8 | |
| First Intervention | STARTED | Mirtazapine->Placebo | 7 | |
| First Intervention | COMPLETED | Placebo->Mirtazapine | 8 | |
| First Intervention | COMPLETED | Mirtazapine->Placebo | 7 | |
| First Intervention | NOT COMPLETED | Placebo->Mirtazapine | 0 | |
| First Intervention | NOT COMPLETED | Mirtazapine->Placebo | 0 | |
| Washout | STARTED | Placebo->Mirtazapine | 8 | |
| Washout | STARTED | Mirtazapine->Placebo | 7 | |
| Washout | COMPLETED | Placebo->Mirtazapine | 6 | |
| Washout | COMPLETED | Mirtazapine->Placebo | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events4
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 |
|---|---|---|---|---|---|---|
| other | Muscle Weakness | Musculoskeletal and connective tissue disorders | Mirtazapine | 1 | 13 | 1 |
| other | Muscle Weakness | Musculoskeletal and connective tissue disorders | Placebo | 0 | 12 | 0 |
| serious | Suicidal Thoughts | Psychiatric disorders | Mirtazapine | 0 | 13 | 0 |
| serious | Suicidal Thoughts | Psychiatric disorders | Placebo | 1 | 12 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirtazapine | 0 | 13 |
| Total, all-cause mortality | Placebo | 0 | 12 |
| Total, other adverse events | Mirtazapine | 1 | 13 |
| Total, other adverse events | Placebo | 0 | 12 |
| Total, serious adverse events | Mirtazapine | 0 | 13 |
| Total, serious adverse events | Placebo | 1 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mirtazapine vs Placebo: deaths from any cause | Trial comparisons |
| Mirtazapine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04799782
GET https://conductscience.org/api/trials/v1/NCT04799782/registered