eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea (ELMO)

• ClinicalTrials.gov Identifier: NCT05252156
• Recruitment Status: Completed
• First Posted: February 23, 2022
• Last Update Posted: December 2, 2022
• Sponsor: Signifier Medical Technologies
• Information provided by (Responsible Party): Signifier Medical Technologies

Tracking Information

• First Submitted Date: February 12, 2022
• First Posted Date: February 23, 2022
• Last Update Posted Date: December 2, 2022
• Actual Study Start Date: March 21, 2022
• Actual Primary Completion Date: October 26, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 12, 2022): The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy [ Time Frame: Six weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sleep Apnea, Obstructive

Intervention

Device: eXciteOSA

eXciteOSA

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 12, 2022): 62
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 31, 2022
• Actual Primary Completion Date: October 26, 2022 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05252156
• Other Study ID Numbers: SMT_EOSA_SZT_0003
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Signifier Medical Technologies
• Original Responsible Party: Same as current
• Current Study Sponsor: Signifier Medical Technologies
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Yasser Zayni; yasser.z@signifiermedical.com

• PRS Account: Signifier Medical Technologies
• Verification Date: December 2022