Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tonsillectomy
Procedure/SurgeryTonsillectomy
HGNS
DeviceHGNS alone (without concomitant tonsillectomy)
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: HGNS plus tonsillectomyExperimental treatment 2 interventions
Group B: HGNSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 month of optimized therapy.Secondary outcomes
1
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.
Time frame
1 month of optimized therapy.2
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.
Time frame
1 month of optimized therapy3
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.
Time frame
1 month of optimized therapyOther outcomes
1
PROMIS Sleep Disturbance
The PROMIS Sleep Disturbance Short Form 8b assesses perceptions of sleep quality, sleep depth, and difficulties with sleep. Scores are reported as standardized T-scores (mean = 50 and SD = 10), with higher scores indicating greater sleep disturbance (worse outcome).
Time frame
1 month of optimized therapy2
PROMIS Sleep-Related Impairment
The PROMIS Sleep-Related Impairment Short Form 8a assesses daytime impairment associated with poor sleep, including sleepiness, fatigue, and reduced alertness. Scores are reported as standardized T-scores (mean = 50 and SD = 10), with higher scores indicating greater sleep-related impairment (worse outcome).
Time frame
1 month of optimized therapy3
PROMIS Fatigue
The PROMIS Fatigue Short Form 7a assesses the experience and impact of fatigue on daily functioning. Scores are reported as standardized T-scores (mean = 50 and SD = 10), with higher scores indicating greater fatigue (worse outcome).
Time frame
1 month of optimized therapy4
Sleep apnea quality of life
The Sleep Apnea Quality of Life Index (SAQLI) assesses disease-specific quality of life in obstructive sleep apnea. Total scores range from 1 to 7, with higher scores indicating better sleep-related quality of life (better outcome).
Time frame
1 month of optimized therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Massachusetts Eye and Ear Infirmary
Collaborator
Source ClinicalTrials.gov