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Behavioural Intervention
eXciteOSA for 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 up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the eXciteOSA device on patients with moderate obstructive sleep apnea (OSA). The device sends gentle electrical pulses to the tongue muscles to help keep the airway open during sleep. The study will compare the effects of using the device at two different doses over a period of time. The eXciteOSA device, developed by Signifier Medical Technologies Ltd., is used for daytime neuromuscular electrical training of tongue muscles to improve snoring and mild obstructive sleep apnea.
Eligible Conditions
- Sleep Apnea
- Obstructive Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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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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