Comparing mandibular advancement devices and hypoglossal nerve stimulation for obstructive sleep apnea
Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives (OSANOVA): Comparison of Mandibular Advancement Device and Hypoglossal Nerve Stimulation Outcomes
This study will test whether mandibular advancement devices or hypoglossal nerve stimulation work better for adults with moderate-to-severe obstructive sleep apnea who can't use or won't tolerate CPAP.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07074288 on ClinicalTrials.gov |
What this trial studies
OSANOVA follows two non-randomized cohorts of adults with moderate-to-severe OSA who have declined, failed, or are intolerant of positive airway pressure therapy: one cohort receiving mandibular advancement device (MAD) therapy and one receiving hypoglossal nerve stimulation (HGNS). Researchers will collect baseline and post-intervention patient-reported outcome measures and standard sleep study parameters, with the Pittsburgh Sleep Quality Index (PSQI) as the primary outcome. Secondary outcomes include adverse events, daytime sleepiness (ESS), snoring-related symptoms (SNORE-25), patient satisfaction, clinician-rated global improvement, and treatment re-selection rates. The goal is to directly compare real-world outcomes to inform treatment choice.
Who should consider this trial
Good fit: Adults (≥18 years) with moderate-to-severe OSA (AHI ≥15) who have declined, failed, or are intolerant of PAP, have BMI ≤40 kg/m², predominantly obstructive apneas (<25% central/mixed), can attend the Washington University site, and are planning to receive MAD or HGNS are ideal candidates.
Not a fit: Patients with mild OSA, predominantly central sleep apnea, BMI >40 kg/m², those comfortable using PAP, or those unwilling/unable to undergo the required interventions or follow-up visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help patients and clinicians choose the non‑PAP treatment that most improves sleep quality and daily symptoms.
How similar studies have performed: Both MAD and HGNS have demonstrated benefit for obstructive sleep apnea in prior studies, but direct head-to-head comparisons in PAP‑failing patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must consent to being a part of the study * Must be willing and able to physically present to the our office site on the Hospital campus whenever necessary over the course of the study * Able to read, write, speak, and understand English * Willing to complete study surveys over the course of the study. * Must have a diagnosis for moderate to severe OSA (AHI ≥15) with indications for PAP therapy OSA is stratified into mild (5 ≤ AHI ≤ 15), moderate (15 \< AHI ≤ 30), and severe (AHI\>30) * Must have declined PAP therapy (unwillingness to use), failed PAP therapy (AHI \> 15 on PAP), or are inadherent to PAP therapy (not using PAP ≥4 hours/night for ≥5 nights per week, also defined as intolerance to PAP) * Age ≥ 18 years * BMI ≤ 40 kg/m² * Central/Mixed apneas contribute \< 25% of AHI (Predominantly Obstructive Sleep Apnea) * Willing to complete pre-intervention and post-intervention sleep studies * Planning to obtain MAD or HGNS as part of clinical care Exclusion Criteria: * AHI \> 65 o The guidelines for HGNS usage were originally approved for an AHI upper limit of 65. We will not enroll anyone in the study with an AHI greater than 65. * Dental conditions such as temporomandibular joint disease, periodontal disease, dental disease, insufficient dentition (edentulism) to support appliance retention, and inadequate range of motion of the jaw. Similarly, patients undergoing dental realignment (e.g., braces or retaining device) are not suitable candidates. * Chronic nasal obstruction * Individuals without manual dexterity to place and remove the device such as those afflicted with severe arthritis, or neuromuscular disease that affects dexterity. * Prior intolerance to MAD * Rapid therapy required: patients in whom rapid initiation of treatment is desirable (e.g., patients with severe symptomatic OSA, sleepiness while driving) and they declined PAP without PAP failure. PAP therapy can be initiated quickly while MAD initiation requires incremental titration of the device over weeks to months to attain optimal efficacy. * Severe or prolonged Oxygen desaturation: patients with severe oxyhemoglobin desaturation during sleep (e.g., nadir peripheral oxygen saturation \[SpO2\] \<70 percent), caution is warranted as oral appliance therapy may not provide optimal improvement in oxygenation. * Alcohol or illicit substance use at least daily * Unstable psychiatric condition * Current use of a GLP-1 receptor agonist (e.g., Zepbound, Wegovy, Ozempic, Mounjaro) with ongoing, active weight loss at the time of enrollment, or recent dose escalation within the prior 8 weeks.
Where this trial is running
St Louis, Missouri
- Washington University — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Jay F Piccirillo, MD — Washington University School of Medicine
- Study coordinator: Sara Kukuljan
- Email: kukuljas@wustl.edu
- Phone: 314-362-7563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.