eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT05252156
• Lead Sponsor: Signifier Medical Technologies

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-12
• Study First Submitted QC: 2022-02-12
• Study First Posted: 2022-02-23
• Study Start: 2022-03-21
• Primary Completion: 2022-10-26
• Study Completion: 2022-10-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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• Use of any overnight therapy that cannot be withdrawn during study enrollment;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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy	Six weeks

Trial Locations

Locations (7)

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; 🇺🇸 Saint Louis, Missouri, United States

Ohio Sleep Medicine Institute; 🇺🇸 Dublin, Ohio, United States

Bogan Sleep Consultants; 🇺🇸 Columbia, South Carolina, United States