Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study)
NCT ID: NCT04974515
Last Updated: 2023-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-08-17
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Low intensity application of eXciteOSA
Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks.
eXciteOSA
eXciteOSA is a device for improving genioglossus endurance through electrical stimulation
High intensity application of eXciteOSA
Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks.
eXciteOSA
eXciteOSA is a device for improving genioglossus endurance through electrical stimulation
Interventions
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eXciteOSA
eXciteOSA is a device for improving genioglossus endurance through electrical stimulation
Eligibility Criteria
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Inclusion Criteria
2. Ability to consent
3. Home sleep apnea test demonstrating mild obstructive sleep apnea.
4. Smartphone or tablet
Exclusion Criteria
2. No prior oropharyngeal surgery for sleep apnea
3. No implants, metal prostheses, dental braces, or soft tissue/bony ulcerations in the oral cavity
4. No prior use of mandibular advancement device (MAD) or continuous positive airway pressure (CPAP)
5. Heart failure (New York Heart Association Class 3 or 4; or ejection fraction \< 45%)
6. Active coronary disease defined as an intervention (e.g., angioplasty, coronary artery bypass surgery) in the prior 6 months
7. Uncontrolled hypertension (BP \> 160/100)
8. Clinician diagnosis of any chronic lung disease except asthma
9. Chronic fatigue syndrome or fibromyalgia
10. Self-reported current illicit drug use in the past 30 days
11. Self-reported use of marijuana or opiates in the past 30 days
12. Use of supplemental oxygen
13. Self-reported use of prescribed or over the counter sleeping medications in the past 30 days
14. Current pregnancy or intention of becoming pregnant
15. Oropharyngeal abnormalities (class 2 or class 3 malocclusion)
16. Periodic breathing (Cheyne Stoke respiration)
17. Central sleep apnea (central apnea index (CAI) \> 5/h)
18. Investigator discretion
19. Prisoners
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Naresh Punjabi
Professor of Clinical
Principal Investigators
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Naresh Punjabi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20210068
Identifier Type: -
Identifier Source: org_study_id
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