Status:
COMPLETED
Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing)
Lead Sponsor:
Inspire Medical Systems, Inc.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two randomization arms, at 6 months post-activation
Detailed Description
This study is a prospective, randomized, non-blinded, multi-center study of therapy optimization related to the Inspire UAS System (implanted in a commercial setting under current labeling). Comparis...
Eligibility Criteria
Inclusion
- Patient is ≥ 22 years of age;
- Patient has been diagnosed with moderate to severe OSA, with a baseline (pre-implant) AHI ≥ 15 based on a qualified sleep study;
- Patient has been implanted with the Inspire UAS System but not yet activated, or has been scheduled for implant of the Inspire UAS System;
- Patient currently owns a SmartPhone and is willing and able to install and use SmartPhone apps (at no cost to patient);
- Patient is willing to utilize study equipment at home including Home Sleep Test (HST) equipment, pulse oximetry equipment, and sleep tracking equipment in accordance with the study protocol;
- Patient is willing and able to return for all follow-up study visits;
- Patient is willing to be randomized and adhere to randomization allocation;
- Patient is willing to and capable of providing informed consent.
Exclusion
- Patient has central + mixed apneas more than \> 25% of the total AHI;
- Patient currently uses adjunctive sleep therapy (eg. CPAP, oral appliance, positional therapy) and will not discontinue use of adjunctive therapy upon implant of the Inspire UAS System;
- Patient is pregnant or plans to become pregnant;
- Patient has a terminal illness with life expectancy \< 12 months;
- Any other reason the investigator deems that the patient is unfit for participation in the study.
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04416542
Start Date
July 28 2020
End Date
June 10 2022
Last Update
June 21 2022
Active Locations (5)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
2
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02115
3
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44104
4
Ohio Sleep Medicine Institute
Dublin, Ohio, United States, 43107