Severe OSA Study (SOS) (NCT05445869) | Clinical Trial Compass
TerminatedNot Applicable
Severe OSA Study (SOS)
Stopped: Study terminated by Sponsor.
United States35 participantsStarted 2022-09-12
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Inability to breathe through the nose comfortably
✕. Presence of \> 25% CSA
✕. Presence of positional obstructive sleep apnea per Cartwright's definition32
What they're measuring
1
Efficacy (apnea-hypopnea index)
Timeframe: 6 months
2
Efficacy (oxygen desaturation index)
Timeframe: 6 months
3
Evaluation of safety (adverse events, dental examinations, safety examinations)
✕. 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)