Status:
COMPLETED
Effect of Upper Airway Stimulation in Patients With Obstructive Sleep Apnea
Lead Sponsor:
Technical University of Munich
Collaborating Sponsors:
Universitätsmedizin Mannheim
University of Luebeck
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Upper Airway Stimulation is a new therapy, which is available for patients with obstructive sleep apnea, who are non-compliant to the standard treatment continuous positive airway pressure (CPAP) ther...
Detailed Description
Obstructive Sleep Apnea (OSA) is characterized by recurrent episodes of airflow obstruction in the upper airway that results in oxygen desaturations and arousal from sleep. The most common symptom of ...
Eligibility Criteria
Inclusion
- Otherwise healthy subjects that are at least 18 years old and:
- Have been implanted and using the Inspire Therapy for at least six months
- Willing and capable to undergo three in-lab PSGs in a one-month timeframe
- Willing and capable of having reduced Inspire stimulation for one week
- Willing and capable of providing informed consent
Exclusion
- Subjects who meet any of the following criteria will be excluded from this clinical investigation:
- Unwilling to complete three in-lab PSGs within a 1-month timeframe
- Any other reason the investigator deems subject is unfit for participation in the study
Key Trial Info
Start Date :
January 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03760328
Start Date
January 16 2019
End Date
December 30 2021
Last Update
November 27 2023
Active Locations (1)
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1
Department of Ear Nose Throat
Munich, Bavaria, Germany, 81675