Trial · NCT07898618
Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse
NCT07898618, Not applicable, Not yet recruiting, Brigham and Women's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse. Trials, record NCT07898618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07898618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse
- NCT number
- NCT07898618
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Inspire Hypoglossal Nerve Stimulation System
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | HGNS-induced change in pharyngeal critical closing pressure (Pcrit) | During one overnight physiological study 4-12 months after implantation, once HGNS settings are stable | Difference in critical closing pressure (cm H2O), calculated as Pcrit with HGNS off minus Pcrit with HGNS on during the same physiological study. Larger positive values indicate greater improvement. Pcrit is measured using brief CPAP pressure drops. CCC-specific results will be characterized, and CCC data will contribute to the prespecified pooled comparison of lateral versus predominantly anteroposterior collapse using a separately enrolled companion cohort. |
| Secondary | Percentage reduction in apnea-hypopnea index (AHI) | Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation | Percentage reduction from the participant's own pre-implant baseline AHI to HGNS-on follow-up AHI: 100 × (baseline AHI minus treated AHI) / baseline AHI. AHI is the number of apneas and hypopneas per hour of sleep. Larger positive percentages indicate greater improvement. |
| Secondary | Percentage of participants meeting HGNS treatment-response criteria | Approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation | Response is defined as at least a 50% reduction in AHI from pre-implant baseline and a treated AHI below 15 events/hour. |
| Secondary | HGNS use relative to total sleep time | Prior month of device use, downloaded at the first in-laboratory study visit 4-12 months after implantation | Average nightly HGNS use over the preceding month divided by average nightly total sleep time estimated from seven nights of wearable ring monitoring. HGNS use is obtained from the device download at the first in-laboratory study visit 4-12 months after implantation. |
| Secondary | Percentage of participants meeting HGNS adherence criteria | Prior month of device use, downloaded at the first in-laboratory study visit 4-12 months after implantation | Adherence is defined as device use for at least 4 hours per night on at least 70% of nights, based on device downloads. |
| Secondary | Epworth Sleepiness Scale | Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation | The Epworth Sleepiness Scale assesses subjective daytime sleepiness. Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness (worse outcome). Assessed at baseline, the early post-titration visit, and 12 months after implantation. |
| Secondary | PROMIS Sleep Disturbance Short Form 8b | Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation | The PROMIS Sleep Disturbance Short Form 8b assesses perceptions of sleep quality, sleep depth, and difficulties with sleep. Scores are reported as standardized T-scores (mean = 50 and SD = 10), with higher scores indicating greater sleep disturbance (worse outcome). Assessed at baseline, the early post-titration visit, and 12 months after implantation. |
| Secondary | PROMIS Sleep-Related Impairment Short Form 8a | Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation | The PROMIS Sleep-Related Impairment Short Form 8a assesses daytime impairment associated with poor sleep, including sleepiness, fatigue, and reduced alertness. Scores are reported as standardized T-scores (mean = 50 and SD = 10), with higher scores indicating greater sleep-related impairment (worse outcome). Assessed at baseline, the early post-titration visit, and 12 months after implantation. |
| Secondary | Sleep Apnea Quality of Life Index - Short Form | Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation | The Sleep Apnea Quality of Life Index (SAQLI) assesses disease-specific quality of life in obstructive sleep apnea. Total scores range from 1 to 7, with higher scores indicating better sleep-related quality of life (better outcome). Assessed at baseline, the early post-titration visit, and 12 months after implantation. |
| Secondary | PROMIS Fatigue Short Form 7a | Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation | The PROMIS Fatigue Short Form 7a assesses the experience and impact of fatigue on daily functioning. Scores are reported as standardized T-scores (mean = 50 and SD = 10), with higher scores indicating greater fatigue (worse outcome). Assessed at baseline, the early post-titration visit, and 12 months after implantation. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
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.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
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 |
|---|---|---|---|---|---|
| R01HL180582 | Recognizing and resolving laterally directed pharyngeal collapse for successful hypoglossal nerve stimulation therapy in OSA | Vena, Daniel | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL HEART LUNG AND BLOOD INSTITUTE | 2026 |
Source NIH RePORTER
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.
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/NCT07898618
GET https://conductscience.org/api/trials/v1/NCT07898618/registered