Obstructive Sleep ApneaHGNS+TNCT07724938
Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse
A study testing Tonsillectomy and HGNS in people with Obstructive Sleep Apnea and Sleep Disordered Breathing, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Disordered Breathing
- What is being tested?
- Tonsillectomy and HGNS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of obstructive sleep apnea with apnea-hypopnea index (AHI) ≥ 15 events/hour
- Complete oropharyngeal lateral wall (OPLW) collapse identified on DISE
- Candidate for HGNS implantation based on standard clinical criteria
- Presence of small (1-2+) tonsils and eligibility for tonsillectomy
- Untreated OSA at the time of enrollment
- Willing and able to provide written informed consent
Who cannot join
- Absence of tonsils
- Presence of large tonsils (3-4+; not eligible for HGNS)
- Predominant central or mixed sleep apnea (>25% central or mixed events)
- Any unstable or serious medical condition that, in the opinion of the investigator, would increase risk or interfere with study participation
- Ineligibility for HGNS implantation based on standard clinical or surgical criteria
- Inability to comply with study procedures or follow-up assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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:
- Does hypoglossal nerve stimulation combined with tonsillectomy reduce the severity of obstructive sleep apnea more than hypoglossal nerve stimulation alone?
- Does tonsillectomy improve how effectively hypoglossal nerve stimulation opens and stabilizes the upper airway?
Read more
Researchers will compare participants who receive hypoglossal nerve stimulation with tonsillectomy to participants who receive hypoglossal nerve stimulation alone.
Participants will:
- Complete sleep studies, questionnaires, and other assessments before and after treatment
- Be randomly assigned to receive hypoglossal nerve stimulation either with or without tonsillectomy
- Return for follow-up visits and sleep testing to evaluate treatment effectiveness
- In a subset of participants, complete additional overnight testing to measure how treatment changes upper-airway collapsibility
Read the detailed description
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.
- Being tested
- Tonsillectomy, HGNS
- Keywords
- Obstructive sleep apnea, Hypoglossal nerve stimulation, Tonsillectomy
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonsillectomyProcedure or surgery
Tonsillectomy
HGNSDevice
HGNS alone (without concomitant tonsillectomy)
| Study group | Role | What they receive |
|---|---|---|
| HGNS plus tonsillectomy | Experimental | HGNS plus concomitant tonsillectomy Receives: Procedure: Tonsillectomy; Device: HGNS |
| HGNS | Active comparator | HGNS alone (without concomitant tonsillectomy) Receives: Device: HGNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month of optimized therapy.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1 month of optimized therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Sep 2026
- Primary completionAug 2030 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, parallel-group, randomized controlled trial evaluating whether concurrent tonsillectomy enhances the effectiveness of hypoglossal nerve stimulation (HGNS) in adults with obstructive sleep apnea and complete oropharyngeal lateral wall collapse. Participants will be randomized in a 1:1 ratio to receive either HGNS implantation with concurrent tonsillectomy (HGNS+T) or HGNS implantation alone. The primary analysis will compare clinical outcomes between the two randomized groups after approximately one month of optimized HGNS therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary
- Responsible party
- Principal investigator, Daniel Vena, PhD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724938
- Sponsor's protocol ID
- 2026P000343
- Acronym
- HGNS+T
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Vena D, Op de Beeck S, Yang H, Sumner J, Mann D, Wang TY, Aishah A, Azarbarzin A, Messineo L, Calianese N, Alex R, Esmaeili N, Vanderveken OM, White DP, Wellman A, Huyett P, Sands SA. Lateral wall collapse from sleep endoscopy and airflow shape predicts hypoglossal nerve stimulation efficacy in obstructive sleep apnoea. Eur Respir J. 2025 Oct 7;66(4):2500236. doi: 10.1183/13993003.00236-2025. Print 2025 Oct.
PubMed 40774807Huyett P, Kent DT, D'Agostino MA, Green KK, Soose RJ, Kaffenberger TM, Woodson BT, Huntley C, Boon MS, Heiser C, Birk A, Suurna MV, Lin HS, Waxman JA, Kezirian EJ. Drug-Induced Sleep Endoscopy and Hypoglossal Nerve Stimulation Outcomes: A Multicenter Cohort Study. Laryngoscope. 2021 Jul;131(7):1676-1682. doi: 10.1002/lary.29396. Epub 2021 Jan 14.
PubMed 33443811Huyett P, Wellman A, Caruso V, Sumner J, Aishah A, Azarbarzin A, Sands S, Vena D. Combination Tonsillectomy and Hypoglossal Nerve Stimulation for Sleep Apnea Patients With Oropharyngeal Lateral Wall Collapse. Otolaryngol Head Neck Surg. 2024 Dec;171(6):1904-1910. doi: 10.1002/ohn.950. Epub 2024 Aug 27.
PubMed 39189155
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse
- ClinicalTrials.gov ID
- NCT07724938
- Acronym / sponsor ID
- HGNS+T / 2026P000343
- Keywords
- Obstructive sleep apnea, Hypoglossal nerve stimulation, Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does hypoglossal nerve stimulation combined with tonsillectomy reduce the severity of obstructive sleep apnea more than hypoglossal nerve stimulation alone?
- Does tonsillectomy improve how effectively hypoglossal nerve stimulation opens and stabilizes the upper airway?
Researchers will compare participants who receive hypoglossal nerve stimulation with tonsillectomy to participants who receive hypoglossal nerve stimulation alone.
Participants will:
- Complete sleep studies, questionnaires, and other assessments before and after treatment
- Be randomly assigned to receive hypoglossal nerve stimulation either with or without tonsillectomy
- Return for follow-up visits and sleep testing to evaluate treatment effectiveness
- In a subset of participants, complete additional overnight testing to measure how treatment changes upper-airway collapsibility
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, parallel-group, randomized controlled trial evaluating whether concurrent tonsillectomy enhances the effectiveness of hypoglossal nerve stimulation (HGNS) in adults with obstructive sleep apnea and complete oropharyngeal lateral wall collapse. Participants will be randomized in a 1:1 ratio to receive either HGNS implantation with concurrent tonsillectomy (HGNS+T) or HGNS implantation alone. The primary analysis will compare clinical outcomes between the two randomized groups after approximately one month of optimized HGNS therapy.
| Arm | Type | Receives |
|---|---|---|
| HGNS plus tonsillectomy | Experimental | Procedure: Tonsillectomy, Device: HGNSHGNS plus concomitant tonsillectomy |
| HGNS | Active comparator | Device: HGNSHGNS alone (without concomitant tonsillectomy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Diagnosis of obstructive sleep apnea with apnea-hypopnea index (AHI) ≥ 15 events/hour
- Complete oropharyngeal lateral wall (OPLW) collapse identified on DISE
- Candidate for HGNS implantation based on standard clinical criteria
- Presence of small (1-2+) tonsils and eligibility for tonsillectomy
Key exclusion criteria (6 listed)
- Absence of tonsils
- Presence of large tonsils (3-4+; not eligible for HGNS)
- Predominant central or mixed sleep apnea (>25% central or mixed events)
- Any unstable or serious medical condition that, in the opinion of the investigator, would increase risk or interfere with study participation
- Ineligibility for HGNS implantation based on standard clinical or surgical criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TonsillectomyTonsillectomy | Procedure or surgery | HGNS plus tonsillectomy |
| HGNSHGNS alone (without concomitant tonsillectomy) | Device | HGNS, HGNS plus tonsillectomy |
Primary outcome
Percent reduction in apnea-hypopnea index (AHI)
Time frame: 1 month of optimized therapy.
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.
3 secondary outcomes
Absolute change in apnea-hypopnea index
Time frame: 1 month of optimized therapy.
Treatment success
Time frame: 1 month of optimized therapy
Change in Sleep Apnea Hypoxic Burden from Baseline
Time frame: 1 month of optimized therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 40774807Vena D, Op de Beeck S, Yang H, Sumner J, Mann D, Wang TY, Aishah A, Azarbarzin A, Messineo L, Calianese N, Alex R, Esmaeili N, Vanderveken OM, White DP, Wellman A, Huyett P, Sands SA. Lateral wall collapse from sleep endoscopy and airflow shape predicts hypoglossal nerve stimulation efficacy in obstructive sleep apnoea. Eur Respir J. 2025 Oct 7;66(4):2500236. doi: 10.1183/13993003.00236-2025. Print 2025 Oct.
- Background: PubMed 33443811Huyett P, Kent DT, D'Agostino MA, Green KK, Soose RJ, Kaffenberger TM, Woodson BT, Huntley C, Boon MS, Heiser C, Birk A, Suurna MV, Lin HS, Waxman JA, Kezirian EJ. Drug-Induced Sleep Endoscopy and Hypoglossal Nerve Stimulation Outcomes: A Multicenter Cohort Study. Laryngoscope. 2021 Jul;131(7):1676-1682. doi: 10.1002/lary.29396. Epub 2021 Jan 14.
- Background: PubMed 39189155Huyett P, Wellman A, Caruso V, Sumner J, Aishah A, Azarbarzin A, Sands S, Vena D. Combination Tonsillectomy and Hypoglossal Nerve Stimulation for Sleep Apnea Patients With Oropharyngeal Lateral Wall Collapse. Otolaryngol Head Neck Surg. 2024 Dec;171(6):1904-1910. doi: 10.1002/ohn.950. Epub 2024 Aug 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonsillectomy and HGNS in people with Obstructive Sleep Apnea and Sleep Disordered Breathing, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Vena, PhD (16178520719, dvena@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in apnea-hypopnea index (AHI) (time frame: 1 month of optimized therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07724938, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.