eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea (ELMO)

Signifier Medical Technologies

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Device: eXciteOSA

Study type: Interventional

Funder types: Industry

Identifiers

NCT05252156

SMT_EOSA_SZT_0003

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Use of any overnight therapy that cannot be withdrawn during study enrollment;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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 3 patient groups

Therapy Dose-A

Experimental group

Description:

Neuromuscular electrical stimulation; two 20-minute sessions per day.

Treatment:

Device: eXciteOSA

Therapy Dose-B

Experimental group

Description:

Neuromuscular electrical stimulation; one 30-minute session per day.

Treatment:

Device: eXciteOSA

No Therapy

No Intervention group

Description:

Under the care of the referring physician, with no therapy applied