The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.
This is a multi-center, prospective, single-arm study conducted under a common protocol. Each subject will serve as their own control. Each subject will be followed for 5 years from date of implant. Potential study subjects will be considered for study participation and consented once pre-implant screening and implant qualification process have been completed. This includes an in-lab PSG, surgical consultation, and a drug-induced sleep endoscopy procedure. This study will collect pre-operative baseline data including, verification of ineffective CPAP treatment, PSG information, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected. Post-implant, procedure- and device-related adverse events, QoL questionnaires, Functional Tongue Exam, therapy usage and device adjustment data will be collected. In-lab PSG sleep study data will be collected during the 2-month and 1 \& 3 year follow-up visits, home sleep tests will be conducted and data collected at the 6-month and 2, 4, \& 5 year follow-up visits. The subject population will consist of otherwise healthy men and women that are at least 22 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with the study requirements for the specified follow-up duration, and 3) Met all inclusion and exclusion criteria of this protocol. Up to 127 subjects will be implanted at a minimum of 10 and a maximum of 20 qualified sites in the United States.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
127
This is a single-arm study; all participants will be implanted with the Inspire® UAS System, which is a permanent, implantable therapy that consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the study subject receives a remote control to activate the therapy.
The University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
Long-term Device-Related SAEs
This safety endpoint is to assess long-term (5 years) safety via comparison of device-related SAEs with a performance goal of 24%. The objective at 5 years is to demonstrate the device-related SAE rate is no worse than the performance goal.
Time frame: 5 Years Post-Implant
Therapy Specific AEs
This safety endpoint is to evaluate the safety of the Inspire system in the treatment of sleep apnea by evaluating procedure- and device-related AEs occurring immediately post-implant through 12 months post-implant.
Time frame: 12 Months Post-Implant
Long-term Therapy-Related AEs
This safety endpoint is to assess long-term (5 years) safety via the description of all reported AEs, including all therapy- and procedure-related events.
Time frame: 5 Years Post-Implant
Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians
This endpoint is to assess the performance of newly trained physicians, the post-approval study will collect surgical times, post-operative pain recovery, procedure related AEs, and post-operative comments.
Time frame: 30 days post-implant
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South Miami Hospital
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Kentucky Research Group
Louisville, Kentucky, United States
Weill Cornell Medicine
New York, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
University Hospitals
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
...and 4 more locations