Severe Label Expansion for EVO Products Trial

{ "Study of EVO Sleep and Snore Device for Severe Obstructive Sleep Apnea", "This study is looking at the safety and effectiveness of the EVO Sleep and Snore Device for people with severe obstructive sleep apnea (OSA). OSA is a condition where breathing repeatedly stops and starts during sleep. The EVO Sleep and Snore Device is a type of oral appliance that helps keep your airway open. To join, you must be between 18 and 80 years old and have been diagnosed with severe OSA. The study will measure how well the device reduces your apnea-hypopnea index (AHI), which is a measure of how many times your breathing stops or gets very shallow each hour. Success in this study means your AHI is reduced by at least 50% and is less than 20 events per hour after 6 months of using the device. The current status of this study is unclear, and it plans to enroll 49 participants.", "design": "This is a single-arm study, meaning all participants will receive the EVO Sleep and Snore Device. It aims to enroll 49 participants.", "commitments": "You would use the EVO Sleep and Snore Device, and your AHI would be measured at the beginning and again after 6 months using a home sleep apnea test (HSAT).", "compensation": "Not stated in the trial record.", "follow_up": "Your progress will be followed for 6 months after you start using the device.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07090395

Severe Label Expansion for EVO Products Trial

Recruiting
NAAges 18–80InterventionalTreatment
ProSomnus Sleep Technologies
~49 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:EVO Sleep and Snore Device

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sher responder rate endpoint
Measured over 6 months
+1 more outcome measured
Obstructive Sleep Apnea
2 sites across 2 states
New York1
Texas1
  • Erin Mosca, PhD · STUDY_DIRECTOR · ProSomnus Sleep Technologies

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  • Sher responder rate endpoint6 months

    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.

  • Incidence of adverse events6 months

    Evaluation of safety by summarizing all reported device- and/or procedure-related adverse events from the time the EVO device is introduced through 6 months.