Severe OSA Study (SOS)

NCT05445869 | Terminated DMC FDA Device

• 1 other identifier: PST202101
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 5

Brief Summary

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 Snore Device in individuals with severe obstructive sleep apnea.

Conditions

Obstructive Sleep Apnea; Sleep Apnea

Keywords

oral appliance; mandibular advancement device

Outcome Measures

Primary Outcomes (3)

• Efficacy (apnea-hypopnea index)

  The AHI co-primary effectiveness endpoint is to demonstrate a responder rate significantly greater than 50%; responders will be defined as individuals who achieve an AHI \< 15 h-1 with the EVO Sleep and Snore Device 6 months after initiation of the therapy.

  6 months

• Efficacy (oxygen desaturation index)

  The ODI co-primary effectiveness endpoint is to demonstrate a responder rate significantly greater than 50%; responders will be defined as individuals who achieve decrease in ODI from baseline of 25% or more with the EVO Sleep and Snore Device 6 months after initiation of the therapy.

  6 months

• Evaluation of safety (adverse events, dental examinations, safety examinations)

  The primary safety endpoint is to demonstrate an acceptable safety profile of the EVO Sleep and Snore Device, determined through assessment of all reported adverse events, dental examinations, and safety evaluations. There will be no formal statistical analysis.

  6 months

Secondary Outcomes (1)

• Epworth Sleepiness Scale

  6 months

Study Arms (1)

EVO Sleep and Snore Device

EXPERIMENTAL

Participants will be provided with a custom EVO Sleep and Snore Device

Device: ProSomnus® EVO Sleep and Snore Device

Interventions

ProSomnus® EVO Sleep and Snore Device DEVICE

The ProSomnus® EVO Sleep and Snore Device is an intraoral device for snoring and obstructive sleep apnea. It works by repositioning the mandible during sleep, thereby improving the flow of air through the patient's pharyngeal space. The ProSomnus® EVO Sleep consists of maxillary and mandibular device arches that are CAD/CAM designed with twin-mated posts and digitally milled to be patient-specific according to physician prescription. Prescribed advancements can be achieved by simply removing the current upper or lower device arch and inserting the next upper or lower device arch in the mandibular advancement series. The device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps, or repositioning elastics. The device is supplied nonsterile.

EVO Sleep and Snore Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, of any race, aged 18-80 years (inclusive)
• Diagnosed with uncomplicated severe OSA (i.e., AHI \> 30 h-1); where uncomplicated is defined by the absence of:
• Conditions that place the patient at increased risk of non-obstructive sleep-disordered breathing (e.g., central sleep apnea, hypoventilation, and sleep-related hypoxemia). Examples of such conditions include significant cardiopulmonary disease, potential respiratory muscles weakness due to neuromuscular conditions, history of stroke, and chronic opiate medication use.
• 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).
• Environmental or personal factors that preclude the adequate acquisition and interpretation of data from HSAT.
• Body mass index (BMI) \< 40 kg/m2
• Neck circumference \< 50 cm
• Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 \> 87%
• Mandibular range of motion \> 5 mm in protrusive direction
• Adequate dentition, as determined by the site dentist

You may not qualify if:

• Inability to breathe through the nose comfortably
• Presence of \> 25% CSA
• Presence of positional obstructive sleep apnea per Cartwright's definition32
• History of surgery intended to alter anatomy for the correction of OSA, such as uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), or tongue/hyoid suspension. History of surgery intended to restore normal anatomy, such as tonsillectomy, adenoidectomy, septoplasty, or polypectomy, is permitted
• Presence of hypoglossal nerve stimulation device
• Use of CPAP or OAT within the two weeks prior to the screening HSAT
• History of OAT that has been demonstrated to provide effective therapy within the two years prior to the screening HSAT
• Anticipated change in medical therapy during the study protocol that could alter OSA severity (e.g., weight loss surgeries; UPPP, MMA, tongue/hyoid suspension)
• Loose teeth or advanced periodontal disease
• History of temporomandibular joint disorder
• Resistant hypertension, defined as inadequately controlled blood pressure despite therapy with ≥ 3 oral hypertensive agents
• Presence of congestive heart failure, recurrent atrial fibrillation, or coronary artery disease
• Presence of neuromuscular diseases, hypoventilation disorders, or cerebrovascular disease
• Presence of pulmonary disease resulting in significant desaturation, e.g., severe chronic obstructive pulmonary disease, interstitial lung disease (SaO2 nadir of 87%), or pulmonary hypertension
• History of cerebrovascular incident within the last 12 months

Sponsors & Collaborators

• ProSomnus Sleep Technologies: lead

Study Sites (5)

Stanford Sleep Medicine Clinic

Redwood City, California, 94063, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Advanced ENT Physicians and Surgeons of CNY

Fayetteville, New York, 13066, United States

Location

Mount Sinai Integrative Sleep Center

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Erin Mosca, PhD

  ProSomnus Sleep Technologies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: September 12, 2022
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

US (5)