Sleep Apnea, Obstructive
Conditions
Brief summary
The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA (administered at two doses) versus no-therapy for six weeks. Up to 120 participants will be enrolled, in order to randomized n=62.
Interventions
DEVICEeXciteOSA
eXciteOSA
Sponsors
Signifier Medical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged \>=18 years; * Diagnosed with moderate OSA; * Smartphone or tablet capable of running the eXciteOSA app; * Fluent in written and spoken English.
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or PAP for sleep-disordered breathing within the previous four weeks; * Use of any overnight therapy that cannot be withdrawn during study enrollment; * Diagnosed with any sleep disorder other than OSA; * Chronic use of central nervous system depressants; * Driver in a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 (including history of myocardial infarction, cardiac arrhythmia, heart failure, history of stroke, or transient ischemic attack), 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy | Six weeks |
Countries
United States
Outcome results
None listed