eXciteOSA for Treatment of Mild Obstructive Sleep Apnea

Exclusion Criteria

• •BMI \>=35 kg/m2;
• •Implanted medical device;
• •Dental braces and/or intraoral metal jewelry;
• •Any condition impacting the tissue of the oral cavity, including but not limited to ulceration or periodontitis;
• •Symptomatic nasal pathology such as septal deviation, nasal polyposis, or chronic rhinosinusitis;
• •Tonsillar hypertrophy (tonsil size grade 3 or greater);
• •Clinically significant facial or oropharyngeal abnormalities such as class 2 malocclusion;
• •Prior oropharyngeal surgery for sleep-disordered breathing;
• •At-home use of a mandibular advancement device or PAP for sleep-disordered breathing within the previous four weeks;
• •Use of any overnight therapy that cannot be withdrawn during study enrollment;
• •Diagnosed with any sleep disorder other than OSA;
• •Chronic use of central nervous system depressants;
• •Driver in a sleepiness-related vehicular accident or near-miss within the two years prior to enrolment (self-report);
• •Employed as a commercial driver, pilot, or other occupation that may be impacted by hypersomnolence;
• •Considered by the PI to be at risk of an AE resulting from hypersomnolence;
• •Any periods of non-connectivity (wifi or cellular data) exceeding 48 hours planned to take place, or likely to take place, during enrollment;
• •Current or planned pregnancy;
• •Member of a vulnerable population, including but not limited to prisoners and those lacking consent capacity;
• •Clinically-significant burden of comorbidities, and/or any other limitation or condition that may impact the patient's ability to complete the study protocol and use the device per the Instructions for Use (PI discretion);
• •Employee and/or residing household member who is an employee of a company that produces or distributes products designed to diagnose, treat, and/or monitor sleep or sleep-disordered breathing (including the Sponsor).