Status:
UNKNOWN
eXciteOSA for Treatment of Mild Obstructive Sleep Apnea
Lead Sponsor:
Signifier Medical Technologies
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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- Use of any overnight therapy that cannot be withdrawn during study enrollment;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).
Key Trial Info
Start Date :
January 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT05183009
Start Date
January 17 2022
End Date
December 31 2022
Last Update
December 2 2022
Active Locations (7)
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1
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States, 35213
2
Delta Waves
Colorado Springs, Colorado, United States, 80918
3
Florida Lung & Sleep Associates
Lehigh Acres, Florida, United States, 33971
4
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States, 21286