EVO Sleep and Snore Device for Obstructive Sleep Apnea

(SLEEP Trial)

Overseen By Erin Mosca, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ProSomnus Sleep Technologies

Must not be taking: Opiates, Antihypertensives, others

Disqualifiers: Nasal obstruction, Positional OSA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

49 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the EVO Sleep and Snore Device for individuals with severe obstructive sleep apnea, a condition where breathing stops and starts during sleep. The device is a mouthpiece that keeps airways open by adjusting the jaw's position. Participants should have severe sleep apnea without other complex sleep or breathing issues and a body mass index (BMI) under 35. The trial aims to determine if this device can reduce the frequency of breathing interruptions during sleep by at least half. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance sleep apnea treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using CPAP or oral appliance therapy, you must stop these at least two weeks before the baseline sleep study.

What prior data suggests that the EVO Sleep and Snore Device is safe for treating severe obstructive sleep apnea?

Research has shown that the EVO Sleep and Snore Device is safe for treating obstructive sleep apnea. Previous studies found it to be as safe as other similar devices already available, indicating it works similarly and has a comparable safety level.

The FDA has approved the device for mild and moderate obstructive sleep apnea, confirming it has passed safety checks for these conditions. Although it is now being tested for severe cases, its safety record in milder cases offers some reassurance.

Studies have so far focused on tracking any unwanted side effects over six months of use. This ongoing monitoring helps ensure that any safety issues are quickly identified and addressed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The EVO Sleep and Snore Device is unique because it offers a new way to address obstructive sleep apnea by targeting the physical positioning of the jaw and airway, unlike traditional treatments like CPAP machines that use air pressure to keep airways open. This device is designed to be less intrusive and more comfortable, potentially improving compliance among users who find existing options cumbersome. Researchers are excited because it might provide an effective and more user-friendly alternative, enhancing the quality of life for those struggling with sleep apnea.

What evidence suggests that the EVO Sleep and Snore Device is effective for severe obstructive sleep apnea?

Research has shown that the EVO Sleep and Snore Device helps people with severe obstructive sleep apnea. In one study, 80% of patients with severe cases improved using this device. It works by moving the jaw to keep airways open during sleep. All patients in the study used the device as directed for the first three months, indicating ease of use. These results suggest that the EVO device is a promising option for people with severe sleep apnea. ^{2 3 5 6 7}

Who Is on the Research Team?

Erin Mosca, PhD

Principal Investigator

ProSomnus Sleep Technologies

Are You a Good Fit for This Trial?

Adults aged 18-80 with severe obstructive sleep apnea, a BMI under 35 kg/m2, and no major non-respiratory sleep disorders can join. Participants need good dental health and jaw movement, must not have conditions like central sleep apnea or severe lung diseases, and agree to follow the study rules.

Inclusion Criteria

My oxygen levels stay above 87% when I sleep.

I can open my mouth and move my jaw normally.

My teeth are in good condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the EVO Sleep and Snore Device for treatment of severe obstructive sleep apnea

6 months

Regular visits for device titration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EVO Sleep and Snore Device

Trial Overview The trial is testing the EVO Sleep and Snore Device for people with severe obstructive sleep apnea. It's a single-arm study where all participants use this mandibular repositioning device to see if it reduces their Apnea-Hypopnea Index by at least half after six months.

How Is the Trial Designed?

Group I: EVO Sleep and Snore Device Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

ProSomnus Sleep Technologies

Lead Sponsor

Trials

2

Recruited

50+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10703343/

Evaluating the Clinical Performance of a Novel, Precision ... Of the twenty-five patients classified with severe OSA, 80% successfully demonstrated efficacy with the novel OAT device according to the Sher's ...

2. prosomnus.com prosomnus.com/data-published-by-cureus-journal-of-medical-science-shows-successful-treatment-of-obstructive-sleep-apnea-with-prosomnus-precision-oral-appliance-devices/

Data Published by Cureus Journal of Medical Science ... Patients' compliance with the EVO, reported in the first three months of therapy, was 100%. These findings were presented at the 2023 World ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05445869

Study Details | NCT05445869 | Severe OSA Study (SOS) This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and ...

4. advancedsleepsolutions.us advancedsleepsolutions.us/obstructive-sleep-apnea-clinical-trial/

Obstructive Sleep Apnea Clinical Trial The purpose of the study was to evaluate the safety and effectiveness of the ProSomnus® EVO™ Sleep and Snore Device in individuals with severe Obstructive Sleep ...

5. mountsinai.org mountsinai.org/clinical-trials/safety-effectiveness-of-prosomnus-evo-sleep-snore-device-for-treatment-of-severe-osa

Safety and Effectiveness of the ProSomnus EVO Sleep ... Summary: This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221889.pdf

October 6, 2022 ProSomnus Sleep Technologies Divya ... The ProSomnus® EVO™ [PH] Sleep and Snore Device is substantially equivalent to the predicate device with respect to safety and effectiveness.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K202529.pdf

November 20, 2020 ProSomnus Sleep Technologies, Inc ... The ProSomnus@ EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.