Tonsillectomy Added to Hypoglossal Nerve Stimulation for OSA with Lateral Wall Collapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares two approaches for adults with moderate-to-severe obstructive sleep apnea and lateral wall collapse identified during sleep. Participants receive hypoglossal nerve stimulation either with concurrent tonsillectomy or without tonsillectomy. The study assesses airway opening and sleep outcomes after initial optimization of HGNS therapy, with follow-up sleep tests and patient-reported measures. It builds on preliminary data suggesting combined therapy may improve response in patients with lateral wall obstruction. The goal is to determine if adding tonsillectomy provides added benefit over HGNS alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Daniel Vena, PhD
• Email: dvena@bwh.harvard.edu
• Phone: 16178520719

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.