eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea (ELMO)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: eXciteOSA

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Sleep Disorders Center of Alabama
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Delta Waves
  • Florida
    • Lehigh Acres, Florida, United States, 33971
      • Florida Lung & Sleep Associates
  • Maryland
    • Baltimore, Maryland, United States, 21286
      • Pulmonary and Critical Care Associates of Baltimore
  • Missouri
    • Saint Louis, Missouri, United States, 63143
      • Clayton Sleep Institute
  • Ohio
    • Dublin, Ohio, United States, 43017
      • Ohio Sleep Medicine Institute
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Signifier Medical Technologies
• Investigators: Study Director: Yasser Zayni, yasser.z@signifiermedical.com

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: February 12, 2022
• First Submitted That Met QC Criteria: February 12, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: SMT_EOSA_SZT_0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No