Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives

NCT ID: NCT07074288

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-05-31

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%),

Detailed Description

The study will enroll and follow a cohort of PAP-failing patients receiving MAD therapy and a second cohort receiving HGNS therapy. Baseline and post-intervention patient-reported outcome measures (PROMs) and standard sleep study parameters to evaluate and compare treatment efficacy will be captured.

Both MAD and HGNS are accepted treatments for moderate OSA patients following PAP intolerance, refusal, or failure. Current decision-making is based heavily on patient preference rather than well-defined evidence-based recommendations. Choosing the right therapy is a crucial aspect of treatment for OSA, a chronic and lifelong condition.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MAD

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

HGNS

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

HGNS

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jay F. Piccirillo, MD

Professor of Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jay F Piccirillo, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sara Kukuljan

Role: CONTACT

kukuljas@wustl.edu

314-362-7563

Mohamed Jama

Role: CONTACT

mjama@wustl.edu

314-362-9475

Facility Contacts

Sara Kukuljan

Role: primary

kukuljas@wustl.edu

314-362-7563

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Other Identifiers

202502149

Identifier Type: -

Identifier Source: org_study_id