Comparing mandibular advancement devices and hypoglossal nerve stimulation for obstructive sleep apnea

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

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.