NCT07090395

Severe Label Expansion for EVO Products Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: ProSomnus Sleep Technologies · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	EVO Sleep and Snore Device	ProSomnus EVO Sleep and Snore Device mandibular advancement device

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2025-07-29
• Last updated: 2026-03-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study