Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives

NCT07074288 | Recruiting FDA Device

• 1 other identifier: 202502149
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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., AHI, ODI, mean arterial saturation, and Time\<90%),

Conditions

Obstructive Sleep Apnea

Keywords

Otolaryngology; Mandibular Advancement Device therapy; Hypoglossal Nerve Stimulation therapy

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  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.

  baseline(pre-treatment) and through study completion on average 8 weeks

Secondary Outcomes (11)

• Clinical Global Impressions-Improvement (CGI-I)

  through study completion on average 8 weeks

• Epworth Sleepiness Scale (ESS) scores.

  baseline (pre-treatment) and through study completion on average 8 weeks

• Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) scores.

  baseline (pre-treatment) and through study completion on average 8 weeks

• Measure of satisfaction with treatment

  and through study completion on average 8 weeks

• The rate of subject re-selecting the treatment

  and through study completion on average 8 weeks

Study Arms (2)

Mandibular Advancement Device (MAD) therapy

EXPERIMENTAL

This arm includes patients who will receive treatment with a mandibular advancement device, which is an accepted therapy for moderate obstructive sleep apnea (OSA) patients following intolerance, refusal, or failure of positive airway pressure (PAP) therapy.

Device: MAD

Hypoglossal Nerve Stimulation (HGNS) therapy

ACTIVE COMPARATOR

This arm consists of patients who will receive hypoglossal nerve stimulation therapy, another accepted treatment option for moderate obstructive sleep apnea (OSA) patients following intolerance, refusal, or failure of positive airway pressure (PAP) therapy.

Device: HGNS

Interventions

MAD DEVICE

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.

Mandibular Advancement Device (MAD) therapy

HGNS DEVICE

HGNS intervention involves a surgical procedure to implant a device that stimulates the hypoglossal nerve to prevent airway collapse during sleep.

Hypoglossal Nerve Stimulation (HGNS) therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (35)

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MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jay F Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Kukuljan

CONTACT

314-362-7563; kukuljas@wustl.edu

Mohamed Jama

CONTACT

314-362-9475; mjama@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 20, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)