EVO Sleep and Snore Device for severe obstructive sleep apnea

Severe Label Expansion for EVO Products Trial

This trial will test whether the EVO Sleep and Snore Device can cut apnea-hypopnea events by at least half and lower AHI below 20 in adults with severe obstructive sleep apnea.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 49 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: ProSomnus Sleep Technologies (industry)
• Locations: 2 sites (New York, New York and 1 other locations)
• Trial ID: NCT07090395 on ClinicalTrials.gov

What this trial studies

This is a single-arm study of the EVO Sleep and Snore oral appliance in adults with uncomplicated severe obstructive sleep apnea. Up to 49 participants aged 18–80 will receive the EVO mandibular advancement device and undergo device titration. Effectiveness is measured by home sleep apnea testing (HSAT) at baseline and 6 months using the Sher criteria (≥50% AHI reduction and post‑treatment AHI <20); safety is tracked by device- or procedure-related adverse events through 6 months. The study is sponsored by ProSomnus Sleep Technologies and conducted at Mount Sinai (New York) and Star Sleep and Wellness (Dallas).

Who should consider this trial

Good fit: Adults 18–80 with uncomplicated severe OSA (AHI >30) who can use and be titrated on an oral mandibular advancement device and have no significant cardiopulmonary disease or other non‑obstructive sleep disorders.

Not a fit: Patients with central sleep apnea, significant cardiopulmonary disease, neuromuscular weakness, chronic opioid use, or other non‑respiratory sleep disorders are unlikely to benefit or qualify.

Why it matters

Potential benefit: If successful, the EVO device could provide a non‑CPAP oral appliance option to reduce breathing events and improve sleep for some adults with severe OSA.

How similar studies have performed: Mandibular advancement devices are well established for mild–moderate OSA and have shown benefit in selected severe OSA patients in small studies, but use of the EVO device specifically for severe OSA is a label expansion with limited prior evidence.

Eligibility criteria

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 \[e.g., resulting from severe chronic obstructive, interstitial lung disease, or pulmonary hypertension\]). Examples of such conditions include significant cardiopulmonary disease (congestive heart failure, recurrent atrial fibrillation, coronary artery disease, resistant hypertension), potential respiratory muscle weakness due to neuromuscular conditions, history of stroke, and chronic opiate medication use.
   2. Concern for significant non-respiratory sleep disorder(s) that require evaluation (e.g., disorders of central hypersomnolence, parasomnias, sleep-related movement disorders) or interfere with accuracy of HSAT (e.g., severe insomnia).
   3. Environmental or personal factors that preclude the adequate acquisition and interpretation of data from HSAT.
5. Body mass index (BMI) \< 35 kg/m2
6. Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 \> 87%
7. Adequate mandibular range of motion
8. Adequate dentition

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Inability to breathe through the nose comfortably
2. Presence of \> 25% CSA
3. Presence of positional OSA per Amsterdam Positional OSA Classification I definition
4. History of surgery intended to alter anatomy for the correction of OSA

   1. E.g., uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), tongue/hyoid suspension, slow maxillary expansion
   2. History of surgery intended to restore normal anatomy, such as tonsillectomy, adenoidectomy, septoplasty, or polypectomy, is permitted.
5. Presence of hypoglossal nerve stimulation device (active or inactive)
6. Use of CPAP or OAT within the two weeks prior to the baseline sleep study
7. History of OAT that has been confirmed to provide effective therapy within the two years prior to the baseline sleep study
8. Anticipated change in medical therapy during the study protocol that could alter OSA severity (e.g., weight loss surgery, weight loss drug, UPPP, MMA, tongue/hyoid suspension, etc.)
9. Loose teeth or advanced periodontal disease
10. History of temporomandibular joint disorder
11. Resistant hypertension, defined as inadequately controlled blood pressure despite therapy with

    ≥ 3 oral hypertensive agents
12. Use of pacemaker or other life-supporting device
13. Participation in other studies that could interfere with the study protocol
14. Pregnancy or lactation
15. In the opinion of the investigator, unsuitable for inclusion in the study

Where this trial is running

New York, New York and 1 other locations

• Mount Sinai Integrative Sleep Center — New York, New York, United States (RECRUITING)
• Star Sleep and Wellness — Dallas, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Erin Mosca, PhD

Conditions: Obstructive Sleep Apnea, oral appliance therapy, mandibular advancement device, ProSomnus