eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label Randomized Controlled Trial Assessing the Efficacy of Two Levels of Intraoral Neuromuscular Electrical Stimulation for Moderate Obstructive Sleep Apnea: The ELMO Trial

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: eXciteOSA


Participation Criteria
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Eligibility Criteria
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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or PAP for sleep-disordered breathing within the previous four weeks; Use of any overnight therapy that cannot be withdrawn during study enrollment; Diagnosed with any sleep disorder other than OSA; Chronic use of central nervous system depressants; Driver in a sleepiness-related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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy Dose-A<br>Neuromuscular electrical stimulation; two 20-minute sessions per day. | Device: eXciteOSA<br>* eXciteOSA<br>|
| Experimental: Therapy Dose-B<br>Neuromuscular electrical stimulation; one 30-minute session per day. | Device: eXciteOSA<br>* eXciteOSA<br>|
| No Intervention: No Therapy<br>Under the care of the referring physician, with no therapy applied | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |