Severe Label Expansion for EVO Products Trial

Part of paid clinical trials in New York, New York.

Sponsor
ProSomnus Sleep Technologies
Study ID
NCT07090395
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • EVO Sleep and Snore Device — DEVICE
    ProSomnus EVO Sleep and Snore Device mandibular advancement device

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EVO Sleep and Snore Device

Primary Outcome Measure

Sher responder rate endpoint [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mount Sinai Integrative Sleep CenterNew YorkNew York10010
Research Manager
[email protected]
646-988-6927
David Rapoport, MD (PRINCIPAL_INVESTIGATOR)
Star Sleep and WellnessDallasTexas75251
Xzavier Ozuna, MBA
[email protected]
Kent Smith, DDS (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai Integrative Sleep Center· New York, NYStar Sleep and Wellness· Dallas, TX

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