eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea
ELMO
An Open-label Randomized Controlled Trial Assessing the Efficacy of Two Levels of Intraoral Neuromuscular Electrical Stimulation for Moderate Obstructive Sleep Apnea: The ELMO Trial
1 other identifier
interventional
62
1 country
7
Brief Summary
The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA (administered at two doses) versus no-therapy for six weeks. Up to 120 participants will be enrolled, in order to randomized n=62.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedStudy Start
First participant enrolled
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedDecember 2, 2022
December 1, 2022
7 months
February 12, 2022
December 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy
Six weeks
Study Arms (3)
Therapy Dose-A
EXPERIMENTALNeuromuscular electrical stimulation; two 20-minute sessions per day.
Therapy Dose-B
EXPERIMENTALNeuromuscular electrical stimulation; one 30-minute session per day.
No Therapy
NO INTERVENTIONUnder the care of the referring physician, with no therapy applied
Interventions
Eligibility Criteria
You may qualify if:
- Aged \>=18 years;
- Diagnosed with moderate OSA;
- Smartphone or tablet capable of running the eXciteOSA app;
- Fluent in written and spoken English.
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;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213, United States
Delta Waves
Colorado Springs, Colorado, 80918, United States
Florida Lung & Sleep Associates
Lehigh Acres, Florida, 33971, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21286, United States
Clayton Sleep Institute
St Louis, Missouri, 63143, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017, United States
Bogan Sleep Consultants
Columbia, South Carolina, 29201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yasser Zayni
yasser.z@signifiermedical.com
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
February 12, 2022
First Posted
February 23, 2022
Study Start
March 21, 2022
Primary Completion
October 26, 2022
Study Completion
October 31, 2022
Last Updated
December 2, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share