An interventional study of Tonsillectomy and HGNS in Obstructive Sleep Apnea and Sleep Disordered Breathing, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
Among 42 studies in Sleep Apnea, Obstructive by Brigham and Women's Hospital — 12 open to participants now, 12 under way, none of them phase 3. Sleep Apnea, Obstructive · Brigham and Women's Hospital.
Among the 42 studies in Sleep Apnea, Obstructive by Brigham and Women's Hospital, this one is the 8th largest by planned enrollment, is one of 4 that started in 2026, is one of 19 with no phase, reaches primary completion later than 10 of the 11 other live ones, and was the 41st registered.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
Browse Sleep Apnea, Obstructive studies →12 of the 42 studies in Sleep Apnea, Obstructive by Brigham and Women's Hospital are open now, in 1 country. Recruiting first, the newest first:
Brigham and Women's Hospital · Sites in United States
Brigham and Women's Hospital · Sites in United States
Brigham and Women's Hospital · Sites in United States
Brigham and Women's Hospital · Sites in United States
Brigham and Women's Hospital · Sites in United States
By country, each count listing its studies:
Of the 313 Sleep Apnea, Obstructive studies recruiting now, 145 (46%) set no upper age limit and 125 (40%) stop at 75 or younger; 53 take children under 18; 65 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 21
First in 2004; this study’s year is marked. 4 started in 2026.
This study's planned enrollment of 72 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Median enrollment 22 across the 42 interventional studies. Of the 28 that completed or were terminated, 18 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
3 of the studies in Sleep Apnea, Obstructive by Brigham and Women's Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05350215Brigham and Women's HospitalAtomoxetine and DAW2022 on OSA Severity | 2026-12-01 |
| NCT06854211Brigham and Women's HospitalImpacts of Opioids on Respiratory Drive During Sleep | 2027-01-01 |
| NCT06043440Brigham and Women's HospitalDown Syndrome Obstructive Sleep Apnea | 2027-11-30 |
Among the 42 studies in Sleep Apnea, Obstructive by Brigham and Women's Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to learn whether removing the tonsils at the time of hypoglossal nerve stimulation improves treatment of obstructive sleep apnea in adults whose airway collapses from the side of the upper airway during sleep. The main questions it aims to answer are:
Researchers will compare participants who receive hypoglossal nerve stimulation with tonsillectomy to participants who receive hypoglossal nerve stimulation alone.
Participants will:
Obstructive sleep apnea (OSA) is commonly treated with hypoglossal nerve stimulation (HGNS), but treatment efficacy is substantially reduced in patients with complete oropharyngeal lateral wall (OPLW) collapse. HGNS primarily enlarges the airway by protruding the tongue and is therefore most effective in patients with anteroposterior patterns of airway collapse. Tonsillectomy reduces tissue contributing to lateral pharyngeal narrowing and may complement the mechanism of HGNS by addressing residual lateral wall obstruction. Preliminary clinical data suggest that combining tonsillectomy with HGNS substantially improves treatment response compared with HGNS alone in patients with OPLW collapse, but this strategy has not been evaluated in a randomized clinical trial.
This prospective, randomized controlled trial will enroll 72 adults with moderate-to-severe OSA, complete OPLW collapse identified on drug-induced sleep endoscopy, and candidacy for both HGNS implantation and tonsillectomy. Participants will be randomized 1:1 to receive either concurrent HGNS implantation plus tonsillectomy or HGNS implantation alone. All participants will undergo standard postoperative device activation and titration. The primary efficacy endpoint will be assessed after approximately one month of optimized HGNS therapy using sleep studies and patient-reported outcomes. Participants in the HGNS-alone group with persistent OSA may subsequently undergo delayed tonsillectomy as part of standard clinical care, permitting additional within-subject mechanistic comparisons.
The primary objective is to determine whether concurrent tonsillectomy improves the effectiveness of HGNS in reducing OSA severity compared with HGNS alone. Secondary objectives are to determine whether tonsillectomy enhances HGNS-induced improvements in upper-airway collapsibility and to evaluate whether tonsillectomy modifies the physiological effects of HGNS beyond the effects of either treatment alone. In an optional mechanistic substudy, approximately 30 participants will undergo detailed physiological sleep studies to measure pharyngeal collapsibility using gold-standard techniques, providing insight into the mechanisms underlying any observed improvement in clinical outcomes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HGNS plus concomitant tonsillectomy
Procedure: Tonsillectomy · Device: HGNS
HGNS alone (without concomitant tonsillectomy)
Device: HGNS
Tonsillectomy
HGNS alone (without concomitant tonsillectomy)
Percent reduction in apnea-hypopnea index (AHI)
Percent reduction in the apnea-hypopnea index (AHI), measured by overnight polysomnography, from baseline to the primary follow-up sleep study. Higher values indicate greater improvement in obstructive sleep apnea.
Time frame: 1 month of optimized therapy.
Absolute change in apnea-hypopnea index
Absolute change in the apnea-hypopnea index (AHI), measured in events per hour by overnight polysomnography, from baseline to the primary follow-up sleep study. Negative values indicate improvement in obstructive sleep apnea.
Time frame: 1 month of optimized therapy.
Treatment success
Treatment success is defined as a ≥50% reduction in the apnea-hypopnea index (AHI) from baseline and a follow-up AHI \<15 events per hour. The outcome is reported as the proportion of participants meeting this definition (0-100%), with higher values indicating greater treatment success.
Time frame: 1 month of optimized therapy
Change in Sleep Apnea Hypoxic Burden from Baseline
Sleep apnea hypoxic burden will be calculated from overnight polysomnography using the validated Azarbarzin method (PMID: 30376054) as the cumulative area under the oxygen desaturation curve associated with apneas and hypopneas, normalized to total sleep time and expressed as %min/hour. Higher values indicate greater hypoxic burden.
Time frame: 1 month of optimized therapy
PROMIS Sleep Disturbance
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).
Time frame: 1 month of optimized therapy
PROMIS Sleep-Related Impairment
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).
Time frame: 1 month of optimized therapy
PROMIS Fatigue
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).
Time frame: 1 month of optimized therapy
Sleep apnea quality of life
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).
Time frame: 1 month of optimized therapy
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).
Time frame: 1 month of optimized therapy
VAS treatment satisfaction
Participants rate overall satisfaction with treatment on a 0-10 visual analog scale, where 0 indicates not at all satisfied and 10 indicates completely satisfied. Higher scores indicate greater treatment satisfaction (better outcome).
Time frame: 1 month of optimized therapy
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Sep 2026 (actual). Primary completion is estimated for Aug 2030, 47 months after the start.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 47 months is above that.
Counting every sponsor, half of 623 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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