eXciteOSA for Treatment of Mild Obstructive Sleep Apnea (NCT05183009) | Clinical Trial Compass
UnknownNot Applicable
eXciteOSA for Treatment of Mild Obstructive Sleep Apnea
United States102 participantsStarted 2022-01-17
Plain-language 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 trial of eXciteOSA versus no-therapy for six weeks. Up to 200 participants will be enrolled, in order to randomized n=102.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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* Use of any overnight therapy that cannot be withdrawn during study enrollment;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 enrollmen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.