Inspire® Post-Approval Study / Protocol Number 2014-001
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|ClinicalTrials.gov Identifier: NCT02413970|
Recruitment Status : Recruiting
First Posted : April 10, 2015
Last Update Posted : March 1, 2018
|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|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413970
|Contact: Amy Geisfirstname.lastname@example.org|
|United States, Alabama|
|The University of Alabama at Birmingham Medical Center||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Lisa Clemons, MSN, RN, OCN 205-934-9714 email@example.com|
|Principal Investigator: Kirk Withrow, MD|
|Sub-Investigator: David Calhoun, MD|
|United States, California|
|University of Southern California||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Yeini C. Guardia firstname.lastname@example.org|
|Principal Investigator: Eric Kezirian, MD|
|Sub-Investigator: Terese Hammond, MD|
|Sub-Investigator: Baljinder Sidhu, MD|
|United States, Florida|
|Baptist Hospital of Miami||Recruiting|
|Miami, Florida, United States, 33183|
|Principal Investigator: Jeremy Tabak, MD|
|Sub-Investigator: Rolando Molina, MD|
|Tampa General Hospital||Recruiting|
|Tampa, Florida, United States, 33606|
|Contact: Laurie Joughin, RN 813-844-8153 email@example.com|
|Principal Investigator: Tapan Padhya, MD|
|Sub-Investigator: Karel Calero, MD|
|United States, Georgia|
|Emory University Hospital||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Everett Seay 404-778-3015 firstname.lastname@example.org|
|Principal Investigator: Raj C Dedhia, MD|
|United States, Kentucky|
|Kentucky Research Group||Terminated|
|Louisville, Kentucky, United States, 40218|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10021|
|Contact: Teresa Valderrama, MPH 646-962-5399 email@example.com|
|Principal Investigator: Maria Suurna, MD|
|Sub-Investigator: Ana Krieger, MD|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45219|
|Contact: Linda Martin 513-585-1777 firstname.lastname@example.org|
|Principal Investigator: Joseph Hellman, MD|
|Cleveland, Ohio, United States, 44106|
|Contact: Mary Andrews, RN 216-844-2386 Mary.Andrews@UHhospitals.org|
|Principal Investigator: Kingman Strohl, MD|
|Sub-Investigator: Mark Weidnbecher, MD|
|Sub-Investigator: John Andrefsky, MD|
|Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Joan Aylor 216-445-1698 email@example.com|
|Principal Investigator: Tina Waters, MD|
|Principal Investigator: Douglas Trask, MD|
|Sub-Investigator: Alan Kominskey, MD|
|Sub-Investigator: Harneet Walia, MD|
|Sub-Investigator: Reena Mehra, MD|
|United States, Pennsylvania|
|University of Pennsylvania, Division of Sleep Medicine||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Nadia Azad 734-709-3747 Nadia.Azad@uphs.upenn.edu|
|Principal Investigator: Richard J Schwab, MD|
|Sub-Investigator: Erica Thaler, MD|
|Sub-Investigator: Ronald Kotler, MD|
|Sub-Investigator: James Kearney, MD|
|Thomas Jefferson University and Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Elizabeth Duddy 215-503-6828 firstname.lastname@example.org|
|Principal Investigator: Maurtis Boone, MD|
|Sub-Investigator: Karl Doghramji, MD|
|University of Pittsburgh Medical Center||Terminated|
|Pittsburgh, Pennsylvania, United States, 15219|
|United States, South Carolina|
|Medical University of South Carolina||Terminated|
|Charleston, South Carolina, United States, 29425|
|Study Director:||Quan Ni, PhD||Inspire Medical Systems, Inc.|