Actively Recruiting
Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives
Led by Washington University School of Medicine · Updated on 2026-04-14
60
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 �3E�3D15) with indications for PAP therapy
- Must have declined PAP therapy (unwillingness to use), failed PAP therapy (AHI �3E 15 on PAP), or are inadherent to PAP therapy (not using PAP �3E4 hours/night for �3E5 nights per week, also defined as intolerance to PAP)
- Age �3E�3D 18 years
- BMI �3C= 40 kg/m�b2
- Central/Mixed apneas contribute �3C 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 will not qualify if you...
- AHI �3E 65
- Dental conditions such as temporomandibular joint disease, periodontal disease, dental disease, insufficient dentition to support appliance retention, and inadequate jaw motion
- Patients undergoing dental realignment like braces or retaining devices
- Chronic nasal obstruction
- Lack of manual dexterity to place and remove the device due to conditions like severe arthritis or neuromuscular disease
- Prior intolerance to MAD
- Need for rapid therapy initiation (e.g., severe symptoms or sleepiness while driving) who declined PAP without PAP failure
- Severe or prolonged oxygen desaturation during sleep (nadir SpO2 �3C 70%)
- Daily alcohol or illicit substance use
- Unstable psychiatric conditions
- Current use of GLP-1 receptor agonists with active weight loss or recent dose increase within 8 weeks
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
S
Sara Kukuljan
CONTACT
M
Mohamed Jama
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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