RECRUITING

Severe Label Expansion for EVO Products Trial

Conditions

Obstructive Sleep Apnea oral appliance therapy mandibular advancement device ProSomnus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Severe Label Expansion for EVO Products Trial

Quick Facts

Study Start:2025-08-01

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07090395

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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 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

Inclusion Criteria

Exclusion 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

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
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

Contacts and Locations

Study Contact

Erin Mosca, PhD

CONTACT

925-803-8643

emosca@prosomnus.com

Principal Investigator

Erin Mosca, PhD

STUDY_DIRECTOR

ProSomnus Sleep Technologies

Study Locations (Sites)

Star Sleep and Wellness

Dallas, Texas, 75251

United States

Collaborators and Investigators

Sponsor: ProSomnus Sleep Technologies

Erin Mosca, PhD, STUDY_DIRECTOR, ProSomnus Sleep Technologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-08-01

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

oral appliance therapy
mandibular advancement device
ProSomnus

Additional Relevant MeSH Terms

Obstructive Sleep Apnea