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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05183009
Other study ID # SMT_EOSA_SZT_0002
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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or PAP for sleep-disordered breathing within the previous four weeks; - Use of any overnight therapy that cannot be withdrawn during study enrollment; - Diagnosed with any sleep disorder other than OSA; - Chronic use of central nervous system depressants; - Driver in a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).

Study Design


Related Conditions & MeSH terms


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
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