eXciteOSA for Treatment of Mild Obstructive Sleep Apnea (OREM)

An Open-label Randomized Controlled Trial Assessing the Efficacy of Intraoral Neuromuscular Electrical Stimulation for Treatment of Mild Obstructive Sleep Apnea: The OREM Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: eXciteOSA

• Study Type: Interventional
• Enrollment (Actual): 102
• 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 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).

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapy; Neuromuscular electrical stimulation	Device: eXciteOSA; eXciteOSA
No Intervention: No Therapy; Under the care of the referring physician, with no therapy applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory event index	The difference in the delta-REI (baseline to follow-up) between arms	Six weeks

Collaborators and Investigators

• Sponsor: Signifier Medical Technologies
• Investigators: Study Director: Yasser Zayni, Signifier Medical Technologies

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 10, 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_0002

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