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Obstructive Sleep Apnea Treatments: MAD vs. HGNS

This study, called OSANOVA, is looking at two ways to treat obstructive sleep apnea (OSA) for people who can't use or don't want to use a CPAP machine. It compares a mandibular advancement device (MAD), which repositions your jaw to keep your airway open, with hypoglossal nerve stimulation (HGNS), a device implanted to stimulate a nerve and prevent airway collapse. The study aims to see how these treatments affect your sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI). It plans to include 60 participants who are at least 18 years old, can speak English, and are willing to come to the hospital for visits and complete surveys.

Study design
This is a non-randomized study comparing two groups of participants, one receiving MAD and another receiving HGNS therapy. It plans to enroll 60 participants.
What's involved
You would need to consent to the study, be able to physically come to the office site on the hospital campus when needed, and complete study surveys.
Compensation
Not stated in the trial record.
Follow-up
Your sleep quality will be measured at the beginning of the study and through study completion, which is on average 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07074288

Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives

Recruiting
NAAges 18+InterventionalTreatment
Washington University School of Medicine
~60 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:MADHGNS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pittsburgh Sleep Quality Index (PSQI)
Measured over baseline(pre-treatment) and through study completion on average 8 weeks

Conditions

Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Jay F Piccirillo, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Sara Kukuljan
[email protected]
314-362-7563
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

AHI \> 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.

What this trial measures

  • Pittsburgh Sleep Quality Index (PSQI)baseline(pre-treatment) and through study completion on average 8 weeks

    Pittsburgh Sleep Quality Index (PSQI) asks patients to reflect on their sleep experiences over the last month prior to assessment. The global PSQI score is calculated by summing all seven components scores (i.e., subjective sleep quality,sleep latency, sleep duration, habitual sleep efficiency,sleep disturbances, use of sleeping medication and daytime dysfunction). Each component is scored between 0 and 3, resulting in a total PSQI score ranging from 0 to 21. A higher score indicates poorer sleep quality, with a global sum greater than 5 signifying poor sleep quality. The change in PSQI is calculated as the difference in PSQI score post-treatment minus PSQI score pre-treatment.