eXciteOSA for Treatment of Mild Obstructive Sleep Apnea

NCT05183009 | Unknown FDA Device

• 1 other identifier: SMT_EOSA_SZT_0002
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 7

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• Respiratory event index

  The difference in the delta-REI (baseline to follow-up) between arms

  Six weeks

Study Arms (2)

Therapy

EXPERIMENTAL

Neuromuscular electrical stimulation

Device: eXciteOSA

No Therapy

NO INTERVENTION

Under the care of the referring physician, with no therapy applied

Interventions

eXciteOSA DEVICE

eXciteOSA

Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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• Use of any overnight therapy that cannot be withdrawn during study enrollment;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

Sponsors & Collaborators

• Signifier Medical Technologies: lead

Study Sites (7)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Delta Waves

Colorado Springs, Colorado, 80918, United States

Location

Florida Lung & Sleep Associates

Lehigh Acres, Florida, 33971, United States

Location

Pulmonary and Critical Care Associates of Baltimore

Baltimore, Maryland, 21286, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

Bogan Sleep Consultants

Columbia, South Carolina, 29201, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Yasser Zayni

  Signifier Medical Technologies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: January 17, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)