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eXciteOSA for Treatment of Mild Obstructive Sleep Apnea (OREM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05183009
Recruitment Status : Active, not recruiting
First Posted : January 10, 2022
Last Update Posted : December 2, 2022
Information provided by (Responsible Party):
Signifier Medical Technologies

Tracking Information
First Submitted Date  ICMJE December 20, 2021
First Posted Date  ICMJE January 10, 2022
Last Update Posted Date December 2, 2022
Actual Study Start Date  ICMJE January 17, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE eXciteOSA for Treatment of Mild Obstructive Sleep Apnea
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sleep Apnea, Obstructive
Intervention  ICMJE Device: eXciteOSA
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 18, 2022)
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2021)
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT05183009
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Signifier Medical Technologies
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Signifier Medical Technologies
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yasser Zayni Signifier Medical Technologies
PRS Account Signifier Medical Technologies
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP