Status:
RECRUITING
Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
American Academy of Sleep Medicine
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Brief Summary
Obstructive sleep apnea (OSA) is a highly prevalent disease resulting from dynamic upper airway collapse during sleep. Continuous positive airway pressure (CPAP) is highly efficacious but high rates o...
Eligibility Criteria
Inclusion
- Male and female participants with moderate or severe sleep apnea (defined by \> 15 apneas and hypopneas per hour of sleep), who are undergoing DISE as part of routine evaluation for Inspire hypoglossal nerve stimulation therapy or for ineffective HGNS therapy.
Exclusion
- Significant cardiac disease, unstable or recent cardiac events
- Active pulmonary, liver or renal disease
- Uncontrolled hypertension (BP\>160/100)
- Neuromuscular disease
- Major psychiatric disease
- Pregnancy
- Anticoagulation therapy (e.g. Coumadin, Dabigatran)
Key Trial Info
Start Date :
November 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 29 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05429983
Start Date
November 29 2022
End Date
November 29 2028
Last Update
December 24 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287