Trial · NCT04639193
Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea
NCT04639193, Phase 2, Completed, University of California, San Diego; results first posted 2024-05-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea. Trials, record NCT04639193. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04639193
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea
- NCT number
- NCT04639193
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- OSA, Obstructive Sleep Apnea
- Interventions
- Acetazolamide, Eszopiclone, Placebo, Venlafaxine
- First posted
- 2020-11-20
- Last updated
- 2024-05-29
- Results first posted
- 2024-05-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Apnea Hypopnea Index (AHI) | 3 nights | The AHI is a measure of sleep apnea severity and based on the American Academy of Sleep Medicine (AASM)-recommended criteria is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a \>=3% desaturation or cortical arousal) per hour of sleep. To avoid confounding by sleep stages and positions across study nights the primary focus was on the AHI during supine non rapid eye movement (NREM) sleep. For comparability with other studies, we also explored the AASM-acceptable "AHI4", which defines hypopneas as reduced breathing for 10+ seconds associated with a \>=4% desaturation. |
| Secondary | SpO2 Nadir | 3 nights | The lowest measured blood oxygen saturation during the overnight sleep study measured in percent. |
| Secondary | Pathophysiological Traits: Vpassive, Vactive, Arousal Threshold | 3 nights | Pathophysiological traits were quantified as %Veupnea from polysomnography data using a validated algorithm. |
| Secondary | Pathophysiological Trait: Loop Gain | 3 nights | Loop Gain 1 was quantified from polysomnography data using a validated algorithm. This metric measures the increase in respiratory drive relative to a preceding drop in ventilation and thus is dimensionless (typical range is approximately 0.2 to 1.5, with values \>0.7 being considered high loop gain, indicating ventilatory instability) |
| Secondary | Percent Responders | 3 nights | Full responders were defined as a drop in AHI\>50% to \<10/h. |
| Secondary | Blood Pressure | 3 nights | Systolic/Diastolic Blood Pressure (measured at rest in the morning following the overnight sleep study). |
| Secondary | Subjective Sleepiness: Stanford Sleepiness Scale (SSS) | 3 nights | Subjective sleepiness was assessed using the Stanford Sleepiness Scale (SSS) in the morning following the overnight sleep study. The score ranges from 1 to 7, with greater values indicating more sleepiness. |
| Secondary | Sleep Quality: PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance | 3 nights | Sleep quality was assessed based on a modified 8-question PROMIS Sleep Disturbance (SDA 8b) questionnaire in the morning following the overnight sleep study. The raw score ranges from 8 to 40 and is translated into a T-score, a standardized score with a mean of 50 and a standard deviation of 10. Greater T-scores indicate greater sleep disturbance. |
| Secondary | Psychomotor Vigilance: Response Speed | 3 nights | Vigilance was assessed using the 10-minute psychomotor vigilance test (PVT) in the morning following the overnight sleep study. Primary focus was on "response speed" 1/reaction time (1/RT) and lapses (reaction time \>500ms). |
| Secondary | Psychomotor Vigilance: Lapses | 3 nights | Vigilance was assessed using the 10-minute psychomotor vigilance test (PVT) in the morning following the overnight sleep study. Primary focus was on "response speed" 1/reaction time (1/RT) and lapses (reaction time \>500ms). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Apnea Hypopnea Index (AHI) | 3 nights | events/hour of sleep | MEDIAN | |
| SECONDARY | SpO2 Nadir | 3 nights | Percent Oxygen Saturation | MEDIAN | |
| SECONDARY | Pathophysiological Traits: Vpassive, Vactive, Arousal Threshold | 3 nights | % Veupnea | MEDIAN | |
| SECONDARY | Pathophysiological Trait: Loop Gain | 3 nights | dimensionless | MEDIAN | |
| SECONDARY | Percent Responders | 3 nights | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Blood Pressure | 3 nights | mmHg | MEDIAN | |
| SECONDARY | Subjective Sleepiness: Stanford Sleepiness Scale (SSS) | 3 nights | units on a scale | MEDIAN | |
| SECONDARY | Sleep Quality: PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance | 3 nights | t-score | MEDIAN | |
| SECONDARY | Psychomotor Vigilance: Response Speed | 3 nights | 1/seconds | MEDIAN | |
| SECONDARY | Psychomotor Vigilance: Lapses | 3 nights | Number of lapses | MEDIAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Apnea Hypopnea Index (AHI) | Dual-Therapy | AHI (supine, NREM) | 17.1 | Inter-Quartile Range 9.4 to 37.7 | events/hour of sleep |
| Apnea Hypopnea Index (AHI) | Placebo | AHI (supine, NREM) | 32.7 | Inter-Quartile Range 23.8 to 51.8 | events/hour of sleep |
| Apnea Hypopnea Index (AHI) | Triple-Therapy | AHI (supine, NREM) | 26 | Inter-Quartile Range 9.2 to 40 | events/hour of sleep |
| Apnea Hypopnea Index (AHI) | Dual-Therapy | AHI (overall) | 23.6 | Inter-Quartile Range 15.2 to 38.3 | events/hour of sleep |
| Apnea Hypopnea Index (AHI) | Placebo | AHI (overall) | 37.4 | Inter-Quartile Range 30.4 to 50 | events/hour of sleep |
| Apnea Hypopnea Index (AHI) | Triple-Therapy | AHI (overall) | 25.8 | Inter-Quartile Range 9.9 to 43.3 | events/hour of sleep |
| Apnea Hypopnea Index (AHI) | Dual-Therapy | AHI4 (overall) | 14.1 | Inter-Quartile Range 7.9 to 27.3 | events/hour of sleep |
| Apnea Hypopnea Index (AHI) | Placebo | AHI4 (overall) | 20.3 | Inter-Quartile Range 13.3 to 37.9 | events/hour of sleep |
| Apnea Hypopnea Index (AHI) | Triple-Therapy | AHI4 (overall) | 9 | Inter-Quartile Range 4.5 to 14.7 | events/hour of sleep |
| SpO2 Nadir | Dual-Therapy | 83.5 | Inter-Quartile Range 79.8 to 87.2 | Percent Oxygen Saturation |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Placebo, Then Dual-Therapy, Then Triple-Therapy | 10 | |
| First Intervention | STARTED | Dual-Therapy, Then Placebo, Then Triple-Therapy | 10 | |
| First Intervention | COMPLETED | Placebo, Then Dual-Therapy, Then Triple-Therapy | 10 | |
| First Intervention | COMPLETED | Dual-Therapy, Then Placebo, Then Triple-Therapy | 10 | |
| First Intervention | NOT COMPLETED | Placebo, Then Dual-Therapy, Then Triple-Therapy | 0 | |
| First Intervention | NOT COMPLETED | Dual-Therapy, Then Placebo, Then Triple-Therapy | 0 | |
| Second Intervention | STARTED | Placebo, Then Dual-Therapy, Then Triple-Therapy | 10 | |
| Second Intervention | STARTED | Dual-Therapy, Then Placebo, Then Triple-Therapy | 10 | |
| Second Intervention | COMPLETED | Placebo, Then Dual-Therapy, Then Triple-Therapy | 10 | |
| Second Intervention | COMPLETED | Dual-Therapy, Then Placebo, Then Triple-Therapy | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events57
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 | Bad Dreams | General disorders | Dual-Therapy | 1 | 20 | |
| other | Bad Dreams | General disorders | Placebo | 0 | 20 | |
| other | Bad Dreams | General disorders | Triple-Therapy | 0 | 18 | |
| other | Cloudy Urine | Renal and urinary disorders | Dual-Therapy | 1 | 20 | |
| other | Cloudy Urine | Renal and urinary disorders | Placebo | 0 | 20 | |
| other | Cloudy Urine | Renal and urinary disorders | Triple-Therapy | 0 | 18 | |
| other | Dizziness | Nervous system disorders | Dual-Therapy | 1 | 20 | |
| other | Dizziness | Nervous system disorders | Placebo | 1 | 20 | |
| other | Dizziness | Nervous system disorders | Triple-Therapy | 0 | 18 | |
| other | Abnormal Taste when Drinking Carbonated Beverages | General disorders | Dual-Therapy | 0 | 20 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dual-Therapy | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, all-cause mortality | Triple-Therapy | 0 | 18 |
| Total, other adverse events | Dual-Therapy | 11 | 20 |
| Total, other adverse events | Placebo | 10 | 20 |
| Total, other adverse events | Triple-Therapy | 16 | 18 |
| Total, serious adverse events | Dual-Therapy | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 20 |
| Total, serious adverse events | Triple-Therapy | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39514000 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
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 |
|---|---|
| Psychomotor Vigilance Task | Secondary outcome |
Source ConductCognition
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/NCT04639193
GET https://conductscience.org/api/trials/v1/NCT04639193/results?page=2