Clinical trial NCT05445869: Severe OSA Study (SOS)
Official title: A Prospective, Multi-Center, Single-Arm, Open-Label, Observational Study on the Safety and Effectiveness of the ProSomnus EVO Sleep and Snore Device in the Treatment of Severe Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Sleep Apnea
Keywords: oral appliance
mandibular advancement device
Lead sponsor: ProSomnus Sleep Technologies
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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 (OSA). Study participants will receive a custom ProSomnus EVO Sleep and Snore device and then be tested using a Type II home sleep apnea test (HSAT) to determine if they have achieved apnea-hypopnea index (AHI) \< 15 h-1 with the device in place. Home sleep apnea testing will be conducted at predetermined timepoints rather than based on subjective measures such as symptom alleviation. After completing a set device advancement and testing protocol, study participants will complete a final HSAT six months after therapy initiation. This value will be used to determine the therapeutic success rate of the appliance. Safety evaluations will be conducted at each study visit that takes place after therapy initiation. These evaluations, along with dental examinations and adverse event reports, will be used to determine if the safety endpoint is met. Participants will continue to be followed for an additional six months after collection of data for the primary endpoints.

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, of any race, aged 18-80 years (inclusive)
4. Diagnosed with uncomplicated severe OSA (i.e., 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). Examples of such conditions include significant cardiopulmonary disease, potential respiratory muscles 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) \< 40 kg/m2
6. Neck circumference \< 50 cm
7. Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 \> 87%
8. Mandibular range of motion \> 5 mm in protrusive direction
9. Adequate dentition, as determined by the site dentist

Exclusion Criteria:

1. Inability to breathe through the nose comfortably
2. Presence of \> 25% CSA
3. Presence of positional obstructive sleep apnea per Cartwright's definition32
4. 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
5. Presence of hypoglossal nerve stimulation device
6. Use of CPAP or OAT within the two weeks prior to the screening HSAT
7. History of OAT that has been demonstrated to provide effective therapy within the two years prior to the screening HSAT
8. Anticipated change in medical therapy during the study protocol that could alter OSA severity (e.g., weight loss surgeries; UPPP, MMA, tongue/hyoid suspension)
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. Presence of congestive heart failure, recurrent atrial fibrillation, or coronary artery disease
13. Presence of neuromuscular diseases, hypoventilation disorders, or cerebrovascular disease
14. 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
15. History of cerebrovascular incident within the last 12 months
16. Use of pacemaker or other life supporting device
17. Anticipated change in body weight \> 5% during the study period
18. Participation in other studies that could interfere with the study protocol
19. Pregnancy or lactation
20. In the opinion of the investigator, unsuitable for inclusion in the study

Primary outcomes:
measure: Efficacy (apnea-hypopnea index)
timeFrame: 6 months
measure: Efficacy (oxygen desaturation index)
timeFrame: 6 months
measure: Evaluation of safety (adverse events, dental examinations, safety examinations)
timeFrame: 6 months
Secondary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Sleep Medicine Clinic
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Fayetteville
country: United States
facility: Advanced ENT Physicians and Surgeons of CNY
state: New York
city: New York
country: United States
facility: Mount Sinai Integrative Sleep Center
state: New York
Study officials:
affiliation: ProSomnus Sleep Technologies
name: Erin Mosca, PhD
role: STUDY_DIRECTOR
References: