Obstructive Sleep Apnea study: Tonsillectomy vs HGNS
Official title Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse
ClinicalTrials.gov ID: NCT07724938
What this study is testing
- What it's testing
- The study wants to see if adding tonsil removal to hypoglossal nerve stimulation lowers sleep‑apnea severity more than the device alone, and if it makes the device work better at keeping the airway open.
- Who it's for
- Adults with obstructive sleep apnea whose airway collapses from the side of the upper airway during sleep.
- What's involved
- Participants will have sleep studies, questionnaires, and other tests before and after treatment. They will be randomly assigned to receive the nerve‑stimulation device with or without tonsil removal, and will return for follow‑up visits and sleep testing. Some may do extra overnight tests to see how the treatment changes airway collapsibility.
- Time commitment
- The study lasts several months, with multiple visits for sleep studies and follow‑up assessments.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.