Recruiting

MAD & HGNS

Sponsor:

Washington University School of Medicine

Code:

NCT07074288

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MAD

HGNS

Study Details

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

Study ID

NCT07074288

Start date

Jun 30, 2025

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mandibular Advancement Device (MAD) therapy

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.

active comparator: Hypoglossal Nerve Stimulation (HGNS) therapy

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.

Interventions

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.

HGNS

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sara Kukuljan

314-362-7563kukuljas@wustl.edu

Mohamed Jama

314-362-9475mjama@wustl.edu

Locations

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Sara Kukuljan

314-362-7563kukuljas@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • Otolaryngology
  • Mandibular Advancement Device therapy
  • Hypoglossal Nerve Stimulation therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-04-14.