eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2022-10-31

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.

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Detailed Description

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therapy Dose-A

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

Group Type EXPERIMENTAL

eXciteOSA

Intervention Type DEVICE

eXciteOSA

Therapy Dose-B

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

Group Type EXPERIMENTAL

eXciteOSA

Intervention Type DEVICE

eXciteOSA

No Therapy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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eXciteOSA

Intervention Type DEVICE

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No