eXciteOSA for Treatment of Mild Obstructive Sleep Apnea (OREM)

• ClinicalTrials.gov Identifier: NCT05183009
• Recruitment Status: Active, not recruiting
• First Posted: January 10, 2022
• Last Update Posted: December 2, 2022
• Sponsor: Signifier Medical Technologies
• Information provided by (Responsible Party): Signifier Medical Technologies

Tracking Information

• First Submitted Date: December 20, 2021
• First Posted Date: January 10, 2022
• Last Update Posted Date: December 2, 2022
• Actual Study Start Date: January 17, 2022
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 20, 2021)

Respiratory event index [ Time Frame: Six weeks ]

The difference in the delta-REI (baseline to follow-up) between arms

• 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 Mild Obstructive Sleep Apnea
• Official Title: An Open-label Randomized Controlled Trial Assessing the Efficacy of Intraoral Neuromuscular Electrical Stimulation for Treatment of Mild Obstructive Sleep Apnea: The OREM Trial
• Brief Summary: The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with mild OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA versus no-therapy for six weeks. Up to 200 participants will be enrolled, in order to randomized n=102.
• 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
  Neuromuscular electrical stimulation
  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: Active, not recruiting
• Actual Enrollment (submitted: January 18, 2022): 102
• Original Estimated Enrollment (submitted: December 20, 2021): 200
• Estimated Study Completion Date: December 31, 2022
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Aged >=18 years;
• Diagnosed with mild OSA;
• Smartphone or tablet capable of running the eXciteOSA app;
• Fluent in written and spoken English (all sites) or Spanish (one site only).

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, 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: NCT05183009
• Other Study ID Numbers: SMT_EOSA_SZT_0002
• 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; Signifier Medical Technologies

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