eXciteOSA for Treatment of Mild Obstructive Sleep Apnea (OREM)

Signifier Medical Technologies

Status

Active, not recruiting

Conditions

Sleep Apnea, Obstructive

Treatments

Device: eXciteOSA

Study type

Interventional

Funder types

Industry

Identifiers

NCT05183009

SMT_EOSA_SZT_0002

Details and patient eligibility

About

The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with mild OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA versus no-therapy for six weeks. Up to 200 participants will be enrolled, in order to randomized n=102.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged >=18 years;
Diagnosed with mild OSA;
Smartphone or tablet capable of running the eXciteOSA app;
Fluent in written and spoken English (all sites) or Spanish (one site only).

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Use of any overnight therapy that cannot be withdrawn during study enrollment;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).