Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyng… (NCT07724938) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse
United States72 participantsStarted 2026-08
Plain-language 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. Does hypoglossal nerve stimulation combined with tonsillectomy reduce the severity of obstructive sleep apnea more than hypoglossal nerve stimulation alone?
2. 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.