NCT07074288 · Washington University School of Medicine
Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives
(OSANOVA)
What this study is about
OSANOVA is a non-randomly assigned clinical trial which aims to compare outcomes of mandibular advancement device (MAD) and hypoglossal nerve stimulation (HGNS) therapies in moderate-to-severe OSA patients who fail, decline, or are intolerant to positive airway pressure (PAP) therapy (referred to as PAP-failing patients).
View original scientific description
OSANOVA is a non-randomized clinical trial which aims to compare outcomes of mandibular advancement device (MAD) and hypoglossal nerve stimulation (HGNS) therapies in moderate-to-severe OSA patients who fail, decline, or are intolerant to positive airway pressure (PAP) therapy (referred to as PAP-failing patients). The primary aim of the study is to compare the outcomes between PAP-failing moderate-to-severe OSA patients receiving MAD and those receiving HGNS therapy. Primary Outcome measures include changes in Pittsburgh Sleep Quality Index (PSQI) scores. Secondary aims will help us describe the outcomes between PAP-failing moderate-to-severe OSA patients receiving MAD and those receiving HGNS therapy. Secondary outcome measures include: * adverse events, * Epworth Sleepiness Scale (ESS), * Symptoms of Nocturnal Obstruction and Related Events (SNORE-25), * patient-reported satisfaction, * CGI-Improvement, * the rate of subjects re-selecting the treatment, and * the rate of subjects recommending the treatment. and * changes in sleep study metrics (i.e.
Interventions
DEVICE
MAD
MAD intervention involves the use of a mandibular advancement device, which is designed to reposition the lower jaw and tongue to keep the airway open during sleep.
DEVICE
HGNS
HGNS intervention involves a surgical procedure to implant a device that stimulates the hypoglossal nerve to prevent airway collapse during sleep.
Primary outcome measures
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations