eXciteOSA for Treatment of Mild Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

— OREM  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05183009
• Other study ID #: SMT_EOSA_SZT_0002
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2022
• Source: Signifier Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Use of any overnight therapy that cannot be withdrawn during study enrollment;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).

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• eXciteOSA
eXciteOSA

Locations

Country	Name	City	State
United States	Pulmonary and Critical Care Associates of Baltimore	Baltimore	Maryland
United States	Sleep Disorders Center of Alabama	Birmingham	Alabama
United States	Delta Waves	Colorado Springs	Colorado
United States	Bogan Sleep Consultants	Columbia	South Carolina
United States	Ohio Sleep Medicine Institute	Dublin	Ohio
United States	Florida Lung & Sleep Associates	Lehigh Acres	Florida
United States	Clayton Sleep Institute	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Signifier Medical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory event index	The difference in the delta-REI (baseline to follow-up) between arms	Six weeks