Actively Recruiting
Severe Label Expansion for EVO Products Trial
Led by ProSomnus Sleep Technologies · Updated on 2026-03-17
49
Participants Needed
2
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Title: Severe Label Expansion for EVO Positioner (SLEEP) Study Description: Single-arm study to determine the safety and effectiveness of treating severe obstructive sleep apnea using the EVO Sleep and Snore Device (ProSomnus Sleep Technologies, Pleasanton, CA). Objectives: To determine the safety and effectiveness of the EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea. Endpoints: The primary effectiveness endpoint is the Sher criteria defined as a reduction of Apnea-Hypopnea Index (AHI) of at least 50% from the baseline value and a post-treatment AHI of less than 20 events/hour at 6 months following initiation of Oral Appliance Therapy (OAT) titration. AHI will be collected using HSAT at baseline and 6 months. The primary safety objective is to evaluate safety by summarizing all reported device and/or procedure related adverse events from the time the EVO device is introduced through 6 months. Study Population: A maximum of 49 individuals over the age of 18 years with severe obstructive sleep apnea will be enrolled. Description of Sites/Facilities Enrolling Participants: The study will be conducted at up to four sites, up to two of which could be located outside of the US. Description of Study Device: The study device is the EVO Sleep and Snore Device (ProSomnus Sleep Technologies, Pleasanton, CA). The device is a mandibular repositioning device used to treat obstructive sleep apnea. The device is currently cleared for the treatment of mild and moderate OSA. Study Duration: The time from when the study opens to enrollment until completion of data analyses is estimated to be 15 months.
CONDITIONS
Official Title
Severe Label Expansion for EVO Products Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 18 to 80 years (inclusive)
- Diagnosed with uncomplicated severe obstructive sleep apnea (AHI > 30 events per hour)
- No conditions increasing risk of non-obstructive sleep-disordered breathing such as central sleep apnea, hypoventilation, severe lung or heart disease, neuromuscular conditions, stroke history, or chronic opiate use
- No significant non-respiratory sleep disorders that require evaluation or interfere with sleep apnea testing
- No environmental or personal factors that prevent accurate sleep apnea testing
- Body mass index (BMI) less than 35 kg/m2
- Mean nocturnal oxygen saturation (SpO2) greater than 87%
- Adequate mandibular range of motion
- Adequate dentition
You will not qualify if you...
- Inability to breathe comfortably through the nose
- Presence of more than 25% central sleep apnea
- Positional obstructive sleep apnea
- History of surgery to alter anatomy for OSA correction (e.g., uvulopalatopharyngoplasty, maxillomandibular advancement, tongue/hyoid suspension, slow maxillary expansion)
- Presence of hypoglossal nerve stimulation device (active or inactive)
- Use of CPAP or oral appliance therapy within two weeks prior to baseline sleep study
- History of effective oral appliance therapy within two years prior to baseline sleep study
- Anticipated medical therapy changes that could affect OSA severity during the study
- Loose teeth or advanced periodontal disease
- History of temporomandibular joint disorder
- Resistant hypertension uncontrolled despite three or more oral antihypertensive agents
- Use of pacemaker or other life-supporting device
- Participation in other interfering studies
- Pregnancy or lactation
- Investigator's judgment of unsuitability for inclusion
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Mount Sinai Integrative Sleep Center
New York, New York, United States, 10010
Actively Recruiting
2
Star Sleep and Wellness
Dallas, Texas, United States, 75251
Actively Recruiting
Research Team
E
Erin Mosca, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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