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Behavioural Intervention
eXciteOSA for Obstructive Sleep Apnea (ELMO Trial)
N/A
Waitlist Available
Research Sponsored by Signifier Medical Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks
Awards & highlights
ELMO Trial Summary
This trial will test a new device to treat moderate OSA. The device will be compared to no treatment and the trial will last for six weeks. Up to 120 participants will be enrolled.
Eligible Conditions
- Obstructive Sleep Apnea
ELMO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy
ELMO Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Therapy Dose-BExperimental Treatment1 Intervention
Neuromuscular electrical stimulation; one 30-minute session per day.
Group II: Therapy Dose-AExperimental Treatment1 Intervention
Neuromuscular electrical stimulation; two 20-minute sessions per day.
Group III: No TherapyActive Control1 Intervention
Under the care of the referring physician, with no therapy applied
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
eXciteOSA
2022
N/A
~110
Find a Location
Who is running the clinical trial?
Signifier Medical TechnologiesLead Sponsor
3 Previous Clinical Trials
417 Total Patients Enrolled
Jessie P Bakker, PhDStudy DirectorSignifier Medical Technologies
2 Previous Clinical Trials
302 Total Patients Enrolled
Yasser ZayniStudy Directoryasser.z@signifiermedical.com
2 Previous Clinical Trials
302 Total Patients Enrolled
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