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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: Recruiting NA study of Obstructive Sleep Apnea, sponsored by ProSomnus Sleep Technologies.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Proportion of participants who meet the Sher criteria at outcome, defined as a reduction of apnea-hypopnea index less than 20 events/hour and 50% or greater reduction from the baseline value.
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 |
What NCT07090395 shows while recruiting
NCT07090395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (78% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07090395's enrollment target sits among peer trials
49 108th of 155 higher than 48 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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