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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.
ClinicalTrials.gov 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

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: eXciteOSA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 17, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Therapy
Neuromuscular electrical stimulation
Device: eXciteOSA

No Intervention: No Therapy
Under the care of the referring physician, with no therapy applied

Primary Outcome Measures :
  1. Respiratory event index [ Time Frame: Six weeks ]
    The difference in the delta-REI (baseline to follow-up) between arms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05183009

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United States, Alabama
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States, 35213
United States, Colorado
Delta Waves
Colorado Springs, Colorado, United States, 80918
United States, Florida
Florida Lung & Sleep Associates
Lehigh Acres, Florida, United States, 33971
United States, Maryland
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States, 21286
United States, Missouri
Clayton Sleep Institute
Saint Louis, Missouri, United States, 63143
United States, Ohio
Ohio Sleep Medicine Institute
Dublin, Ohio, United States, 43017
United States, South Carolina
Bogan Sleep Consultants
Columbia, South Carolina, United States, 29201
Sponsors and Collaborators
Signifier Medical Technologies
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Study Director: Yasser Zayni Signifier Medical Technologies
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Responsible Party: Signifier Medical Technologies
ClinicalTrials.gov Identifier: NCT05183009    
Other Study ID Numbers: SMT_EOSA_SZT_0002
First Posted: January 10, 2022    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases