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Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives

NCT07074288 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-03-31
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07074288 on ClinicalTrials.gov