An interventional study of Inspire Hypoglossal Nerve Stimulation System in Obstructive Sleep Apnea, sponsored by Brigham and Women's Hospital. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Basic science
This study examines how hypoglossal nerve stimulation affects breathing and sleep apnea in adults whose airway closes from all sides at the soft palate during sleep, a pattern called complete concentric collapse. Participants will receive an Inspire hypoglossal nerve stimulation implant and undergo sleep studies, questionnaires, and home monitoring. This use of the device is investigational. The study will measure changes in airway collapsibility, sleep apnea severity, device use, and safety through 12 months after implantation.
This prospective, single-center, open-label investigational cohort will enroll up to 20 adults with obstructive sleep apnea and complete concentric collapse of the soft palate on clinically obtained drug-induced sleep endoscopy. Research assessments occur at Brigham and Women's Hospital; implantation occurs at Massachusetts Eye and Ear. Investigational implantation is conducted under FDA IDE G260193. All enrolled participants receive the intervention; there is no randomization or separate treatment comparison arm.
Baseline eligibility requires attended laboratory polysomnography before implantation. A suitable recent clinical polysomnogram may be used; otherwise a research polysomnogram is obtained after consent. Activation is approximately four weeks after implantation and titration approximately three months after implantation. HGNS-on sleep testing and questionnaires occur approximately one month after titration, targeting completion by six months after implantation, and again at 12 months. Follow-up testing may use laboratory polysomnography or the Nox A1 home sleep testing system.
At 4-12 months after implantation, once device settings are stable, participants undergo a dedicated physiological sleep study following four nights without HGNS. Critical closing pressure is measured during brief CPAP pressure drops with HGNS off and on. During the second portion of the night, HGNS is off and airflow and intraesophageal diaphragm electromyography are used to characterize physiological traits. Participants also complete seven days of wearable ring monitoring; device downloads at the first in-laboratory visit 4-12 months after implantation quantify adherence.
The CCC cohort provides within-participant physiological and clinical response estimates. Prespecified pooled analyses combine these data with a separately enrolled standard-of-care non-CCC cohort. The primary pooled mechanistic comparison evaluates HGNS-induced changes in critical closing pressure between lateral collapse (CCC or complete oropharyngeal lateral wall collapse) and predominantly anteroposterior collapse. Companion-study participants are not included in this registration's enrollment. Exploratory analyses assess physiological traits, treatment response, adherence, and prediction of clinical success.
An independent Data and Safety Monitoring Board reviews safety and treatment response. New enrollment and implantation pause after the first ten implants pending the required response checkpoints and DSMB review. Safety follow-up continues through 12 months after implantation, with continued follow-up of unresolved events as needed.
2,266 studies on the registry are indexed under Sleep Apnea, Obstructive; 468 are open to participants now.
This study's planned enrollment of 20 is below the median of 53 across 1,492 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Brigham and Women's Hospital is the lead sponsor of 1,265 studies on the registry; 226 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
Adults with complete concentric collapse receive Inspire HGNS implantation, activation, titration, and follow-up, with physiological testing and safety assessments through 12 months after implantation.
Device: Inspire Hypoglossal Nerve Stimulation System
Implanted hypoglossal nerve stimulation for obstructive sleep apnea in participants with complete concentric collapse. The system is activated approximately four weeks after implantation and titrated approximately three months after implantation. Stimulation is briefly turned on and off during physiological measurements. Participants withhold HGNS for four nights before the physiological sleep study and resume usual treatment after testing.
Also known as: Inspire Upper Airway Stimulation
HGNS-induced change in pharyngeal critical closing pressure (Pcrit)
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.
Time frame: During one overnight physiological study 4-12 months after implantation, once HGNS settings are stable
Percentage reduction in apnea-hypopnea index (AHI)
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.
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Percentage of participants meeting HGNS treatment-response criteria
Response is defined as at least a 50% reduction in AHI from pre-implant baseline and a treated AHI below 15 events/hour.
Time frame: Approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
HGNS use relative to total sleep time
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.
Time frame: Prior month of device use, downloaded at the first in-laboratory study visit 4-12 months after implantation
Percentage of participants meeting HGNS adherence criteria
Adherence is defined as device use for at least 4 hours per night on at least 70% of nights, based on device downloads.
Time frame: Prior month of device use, downloaded at the first in-laboratory study visit 4-12 months after implantation
Epworth Sleepiness Scale
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.
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
PROMIS Sleep Disturbance Short Form 8b
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.
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
PROMIS Sleep-Related Impairment Short Form 8a
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.
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Sleep Apnea Quality of Life Index - Short Form
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.
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
PROMIS Fatigue Short Form 7a
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.
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Snoring severity visual analog scale
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.
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Treatment satisfaction visual analog scale
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.
Time frame: Approximately 1 month after titration and 12 months after implantation
Number of participants with device-related adverse events or surgical complications
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.
Time frame: From implantation through 12 months after implantation
Plan to share: Yes — De-identified individual participant data underlying published results may be shared with qualified researchers for scientific collaboration. These may include participant characteristics, sleep study outcomes, physiological measurements, HGNS usage, and questionnaire scores. Requests will be reviewed by the Principal Investigator for scientific merit and consistency with participant consent and institutional requirements. Sharing will be subject to any required data use agreement.
Access criteria: Qualified researchers may request de-identified participant data for scientific collaboration by contacting Daniel Vena at dvena@bwh.harvard.edu. Requests should describe the research question and proposed analyses. The Principal Investigator will review requests for scientific merit, consistency with participant consent, and institutional requirements. Approved researchers may receive the data needed for the agreed analyses, subject to any required data use agreement.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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