Status:
COMPLETED
Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study
Lead Sponsor:
Inspire Medical Systems, Inc.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to obtain additional safety and efficacy data on the use of Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep Apnea.
Detailed Description
This is a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. Each subject will serve as their own control. The study will collect pre-operative two-n...
Eligibility Criteria
Inclusion
- Likely suffer moderate-to-severe OSA based on history and physical, or have an established diagnosis of OSA (≥ 15 AHI\<65) based on a prior sleep test
- Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
- Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
- Willing and capable of providing informed consent
Exclusion
- Contraindications
- Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
- Have any condition or procedure that has compromised neurological control of the upper airway
- Unable or do not have the necessary assistance to operate the patient programmer
- Pregnant or plan to become pregnant
- Require magnetic resonance imaging (MRI)
- Have an implantable device that may be susceptible to unintended interaction with the Inspire system.
- Additional exclusions for study purposes only:
- Body Mass Index (BMI) of \> 35
- Central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI)
- Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
- Has a terminal illness with life expectancy \< 12 months
- Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
- Any other reason the investigator deems subject is unfit for participation in the study
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02293746
Start Date
June 1 2014
End Date
January 9 2017
Last Update
July 2 2020
Active Locations (3)
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1
Klinik für HNO-Heilkunde/HNO-Schlaflabor
Lübeck, Germany, 23538
2
Universitäts-HNO-Klinik Mannheim
Mannheim, Germany, D-68135
3
Klinikum rechts der Isar der Technischen Universität München
München, Germany, D-81675