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

NCT04974515 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-10-16

Study results available
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Summary

The purpose of this research is to assess how well people with mild obstructive sleep apnea (OSA) adhere to the eXciteOSA device and specifically examine whether adherence of the device is different with low versus high electrical stimulation. In addition, this research study will assess how well the device affects mild sleep apnea and if it improves sleepiness and quality of life.

Conditions

Interventions

DEVICE

eXciteOSA

eXciteOSA is a device for improving genioglossus endurance through electrical stimulation

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Naresh Punjabi, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-17
Primary Completion
2022-10-31
Completion
2022-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04974515 on ClinicalTrials.gov