Severe Label Expansion for EVO Products Trial
ProSomnus Sleep Technologies
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18-80 years (inclusive) 4. Diagnosed with uncomplicated severe OSA (AHI \> 30 h-1); where uncomplicated is defined by the absence of: 1. Conditions that place the patient at increased risk of non-obstructive sleep-disordered breathing (e.g., central sleep apnea, hypoventilation, and sleep-related hypoxemia \[e.g., resulting from severe chronic obstructive, interstitial lung disease, or pu…
Interventions
- DeviceEVO Sleep and Snore Device
ProSomnus EVO Sleep and Snore Device mandibular advancement device
Locations (2)
- Mount Sinai Integrative Sleep CenterNew York, New York
- Star Sleep and WellnessDallas, Texas