Trial · NCT07577661
Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea
NCT07577661, Phase 1, Phase 2, Recruiting, Brigham and Women's Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea. Trials, record NCT07577661. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07577661
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea
- NCT number
- NCT07577661
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Obstructive Sleep Apnea, Sleep-disordered Breathing
- Interventions
Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy), Unilateral hypoglossal nerve stimulation (HGNS), active comparator condition, Atomoxetine-plus-oxybutynin (80/5 mg) (AtoOxy), active comparator condition, Placebo; placebo comparator condition
- First posted
- 2026-05-11
- Last updated
- 2026-09-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Apnea-Hypopnea Index | 2 Weeks | Apnea-hypopnea index (AHI), defined as the number of apneas and hypopneas per hour of sleep, measured by overnight polysomnography at the end of each treatment period. Quantitative outcome variable: percent change (symmetrized) from baseline. |
| Secondary | Hypoxic Burden | 2 Weeks | Hypoxic burden, defined as the area under the oxygen desaturation curve associated with respiratory events multiplied by event frequency, measured during overnight polysomnography. Quantitative outcome variable: percent change (symmetrized) from baseline. |
| Secondary | Visual Analog Scale for Sleep Quality | 2 Weeks | Self-reported sleep quality measured using a visual analog scale. Quantitative outcome variable: absolute change from baseline. Range: 0-10 (higher values indicate greater sleep quality). |
| Other | Epworth Sleepiness Scale (ESS) | 2 Weeks | Daytime sleepiness assessed using the Epworth Sleepiness Scale (range 0-24, higher scores indicate greater sleepiness). Quantitative outcome variable: absolute change from baseline. |
| Other | Visual Analog Scale for Treatment Satisfaction | 2 Weeks | Self-reported treatment satisfaction measured using a visual analog scale. Quantitative outcome variable: absolute value on treatment. Range: 0-10 (higher values indicate greater treatment satisfaction). |
| Other | Sleep Apnea Quality of Life Index (SAQLI) | 2 Weeks | Disease-specific quality of life assessed using the Sleep Apnea Quality of Life Index. Quantitative outcome variable: absolute change from baseline. Range: 1-7 (higher values indicate greater sleep apnea-related quality of life). |
| Other | PROMIS Sleep-Related Impairment | 2 Weeks | Patient-reported outcomes assessing sleep-related impairment: Quantitative outcome variable: absolute change from baseline. Range: 0-100 (mean 50, SD 10; higher T-scores indicate greater impairment). |
| Other | PROMIS Fatigue | 2 Weeks | Patient-reported outcomes assessing fatigue: Quantitative outcome variable: absolute change from baseline. Range: 0-100 (mean 50, SD 10; higher T-scores indicate greater fatigue). |
| Other | PROMIS Sleep Disturbance | 2 Weeks | Patient-reported outcomes assessing sleep disturbance: Quantitative outcome variable: absolute change from baseline. Range: 0-100 (mean 50, SD 10; higher T-scores indicate greater sleep disturbance). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers14
The papers the trial lists on ClinicalTrials.gov.
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.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07577661
GET https://conductscience.org/api/trials/v1/NCT07577661/registered