Trial · NCT07898618
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Snoring severity visual analog scale | Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation | Participants rate snoring severity on a 0-10 visual analog scale, where 0 indicates no snoring and 10 indicates extremely loud, frequent, and bothersome snoring. Higher scores indicate worse snoring. Assessed at baseline, the early post-titration visit, and 12 months after implantation. |
| Secondary | Treatment satisfaction visual analog scale | Approximately 1 month after titration and 12 months after implantation | Participants rate satisfaction with their sleep apnea treatment on a 0-10 visual analog scale, where 0 indicates extremely dissatisfied, 5 indicates neutral / no benefit, and 10 indicates extremely satisfied. Higher scores indicate greater treatment satisfaction. Assessed at the early post-titration visit and 12 months after implantation. |
| Secondary | Number of participants with device-related adverse events or surgical complications | From implantation through 12 months after implantation | Participants with device-related adverse events or surgical complications, including explantation or revision and stimulation intolerance requiring discontinuation or major programming changes. Inadequate therapeutic response requiring reassessment is also monitored. Unresolved events are followed beyond 12 months when needed. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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