Inspire® Post-Approval Study / Protocol Number 2014-001
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02413970|
Recruitment Status : Active, not recruiting
First Posted : April 10, 2015
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Inspire® UAS System||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||127 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Inspire UAS|
|Masking:||None (Open Label)|
|Official Title:||Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study Protocol Number 2014-001|
|Actual Study Start Date :||May 2015|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||June 2025|
Inspire® UAS System
This is a single-arm study; all participants will be implanted with the Inspire® UAS System.
Device: Inspire® UAS System
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.
Other Name: Inspire® therapy
- Long-term Device-Related SAEs [ Time Frame: 5 Years Post-Implant ]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.
- Therapy Specific AEs [ Time Frame: 12 Months Post-Implant ]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.
- Long-term Therapy-Related AEs [ Time Frame: 5 Years Post-Implant ]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.
- Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians [ Time Frame: 30 days post-implant ]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.
- Change in ESS From Baseline to 12 Months [ Time Frame: Baseline and 12 Months ]The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness. The ESS efficacy endpoint will be determined by the ESS score at the 12-month follow-up as compared to baseline.
- Change in FOSQ From Baseline to 12 Months [ Time Frame: Baseline and 12 Months ]The Functional Outcomes of Sleep Questionnaire (FOSQ) is a validated instrument to assess the effect of a subject's daytime sleepiness on activities of ordinary living. The FOSQ endpoint will be determined by the FOSQ score at the 12-month follow-up as compared to baseline.
- Change in ODI From Baseline to 3 Years [ Time Frame: Baseline and 3 Years ]Oxygen Desaturation Index (ODI) is a measure of OSA severity. The ODI will be determined by the ODI score at the 3-year follow-up compared with the pre-implant baseline score.
- Change in AHI From Baseline to 3 Years [ Time Frame: Baseline and 3 Years ]Apnea Hypopnea Index (AHI) is a measure of OSA severity. The AHI in this study will be determined by the AHI score at the 3-year follow-up compared with the pre-implant baseline score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413970
|United States, Alabama|
|The University of Alabama at Birmingham Medical Center|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|South Miami Hospital|
|Miami, Florida, United States, 33183|
|Tampa General Hospital|
|Tampa, Florida, United States, 33606|
|United States, Kansas|
|The University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Kentucky|
|Kentucky Research Group|
|Louisville, Kentucky, United States, 40218|
|United States, New York|
|Weill Cornell Medicine|
|New York, New York, United States, 10021|
|United States, Ohio|
|The Christ Hospital|
|Cincinnati, Ohio, United States, 45219|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania, Division of Sleep Medicine|
|Philadelphia, Pennsylvania, United States, 19104|
|Thomas Jefferson University and Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15219|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Study Director:||Gwen Gimmestad||Inspire Medical Systems, Inc.|