Clinical trial NCT05252156: eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Signifier Medical Technologies
Sponsor class: INDUSTRY
First posted: 2022-02-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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* Use of any overnight therapy that cannot be withdrawn during study enrollment;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).

Primary outcomes:
measure: The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy
timeFrame: Six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Colorado Springs
country: United States
facility: Delta Waves
state: Colorado
city: Lehigh Acres
country: United States
facility: Florida Lung & Sleep Associates
state: Florida
city: Baltimore
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Columbia
country: United States
facility: Bogan Sleep Consultants
state: South Carolina
Study officials:
affiliation: yasser.z@signifiermedical.com
name: Yasser Zayni
role: STUDY_DIRECTOR
References: