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Behavioural Intervention

Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study) (AEGIS Trial)

N/A
Waitlist Available
Led By Alexandre Abreu, MD
Research Sponsored by University of Miami
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 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the eXciteOSA device, which uses electrical pulses to help people with mild obstructive sleep apnea (OSA). The device aims to treat snoring and mild OSA by toning the tongue muscles through electrical stimulation while awake. The study aims to see if people use the device consistently and if different levels of electrical stimulation are more effective. Researchers also want to know if it improves sleepiness and quality of life.

Eligible Conditions
  • Obstructive Sleep Apnea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Number of Days Device Was Used
Secondary study objectives
Epworth Sleepiness Scale (ESS) Scores
Mean Respiratory Event Index (REI)
Number of Participants Accepting Long Term Treatment
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Low intensity application of eXciteOSAExperimental Treatment1 Intervention
Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks.
Group II: High intensity application of eXciteOSAActive Control1 Intervention
Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks.
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?

University of MiamiLead Sponsor
950 Previous Clinical Trials
428,353 Total Patients Enrolled
Alexandre Abreu, MDPrincipal InvestigatorUniversity of Miami
Naresh Punjabi, MDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
277 Total Patients Enrolled
~9 spots leftby Dec 2025
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