eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea
Completed · Not applicable
Conditions studied: Sleep Apnea, Obstructive
In brief
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.
Key facts
- Study ID
- NCT05252156
- Run by
- Signifier Medical Technologies
- People needed
- 62
- Starts
- 2022-03-21
- Expected to finish
- 2022-10-31
- Last updated by the study team
- 2022-12-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged >=18 years;
- Diagnosed with moderate OSA;
- Smartphone or tablet capable of running the eXciteOSA app;
- Fluent in written and spoken English.
You may not qualify if…
- 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- Use of any overnight therapy that cannot be withdrawn during study enrollment;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).
Where it is running
- Sleep Disorders Center of Alabama — Birmingham, Alabama, United States
- Delta Waves — Colorado Springs, Colorado, United States
- Florida Lung & Sleep Associates — Lehigh Acres, Florida, United States
- Pulmonary and Critical Care Associates of Baltimore — Baltimore, Maryland, United States
- Clayton Sleep Institute — St Louis, Missouri, United States
- Ohio Sleep Medicine Institute — Dublin, Ohio, United States
- Bogan Sleep Consultants — Columbia, South Carolina, United States
Full record on ClinicalTrials.gov
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