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NCT07090395 · ClinicalTrials.gov registry record · NA
Severe Label Expansion for EVO Products Trial
A NA study of Obstructive Sleep Apnea, sponsored by ProSomnus Sleep Technologies.
- Recruiting
- Registry status
- NA
- Development phase
- 49
- Enrollment target
- 2
- Study locations
NCT07090395 is a NA study of Obstructive Sleep Apnea that is actively recruiting participants, run by ProSomnus Sleep Technologies. The registered enrollment target is 49 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT07090395, a NA study of Obstructive Sleep Apnea, is actively recruiting participants, sponsored by ProSomnus Sleep Technologies.
- RECRUITING
- Registry status
- NA
- Development phase
- 49 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DEVICE EVO Sleep and Snore Device
Study Locations (2)
New York
- Mount Sinai Integrative Sleep Center - New York
Texas
- Star Sleep and Wellness - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07090395
The ClinicalTrials.gov registry entry for NCT07090395 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (78% lower). The listed sponsor is ProSomnus Sleep Technologies, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which EVO Sleep and Snore Device is the first listed.
NCT07090395 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Texas.
Frequently Asked Questions
What is clinical trial NCT07090395 about?
NCT07090395 is a clinical study titled "Severe Label Expansion for EVO Products Trial". 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 ...
What is the current status of trial NCT07090395?
This trial is currently recruiting. It is a NA study. The enrollment target is 49 participants. The study started on 2025-08-01. Estimated completion is 2026-12-31.
What conditions does trial NCT07090395 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT07090395?
The interventions under investigation include: EVO Sleep and Snore Device (DEVICE).
Who is sponsoring clinical trial NCT07090395?
This trial is sponsored by ProSomnus Sleep Technologies, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07090395 being conducted?
This trial has 2 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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