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Tonsillectomy and Hypoglossal Nerve Stimulation for Sleep Apnea

This study is looking at adults with obstructive sleep apnea (OSA) where the side walls of their throat collapse during sleep. Researchers want to see if removing the tonsils at the same time as getting a hypoglossal nerve stimulation (HGNS) device helps more than just getting the HGNS device alone. HGNS is a device that helps open your airway by moving your tongue forward. The study aims to find out if combining tonsillectomy with HGNS reduces sleep apnea more effectively and improves how well HGNS works. You might be able to join if you are 18 or older, have moderate to severe OSA, and are a candidate for both HGNS and tonsillectomy. The main goal is to see how much your apnea-hypopnea index (AHI) improves after about one month of treatment.

Study design
This is a randomized controlled trial involving 72 participants. You would be randomly assigned to receive either HGNS with tonsillectomy or HGNS alone.
What's involved
You would undergo either HGNS implantation with tonsillectomy or HGNS implantation alone. After surgery, you would have standard device activation and adjustments, with an assessment after about one month of optimized therapy.
Compensation
Not stated in the trial record.
Follow-up
Your primary outcome will be measured after approximately one month of optimized therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07724938

Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Brigham and Women's Hospital
~72 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:TonsillectomyHGNS

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent reduction in apnea-hypopnea index (AHI)
Measured over 1 month of optimized therapy.

Conditions

Obstructive Sleep Apnea
Sleep Disordered Breathing

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Daniel Vena, PhD
[email protected]
16178520719
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Percent reduction in apnea-hypopnea index (AHI)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.