Inspire® Post-Approval Study / Protocol Number 2014-001
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: Inspire® UAS System
- Registration Number
- NCT02413970
- Lead Sponsor
- Inspire Medical Systems, Inc.
- Brief Summary
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 127
- Likely suffer moderate-to-severe OSA based on history and physical or have an established diagnosis of OSA (AHI >= 15) based on a prior sleep study
- Documentation the subject not effectively treated with CPAP therapy. (Examples include non-compliance, discomfort, undesirable side effects, symptoms persist despite use). Subjects who have been prescribed, but refuse to try CPAP would be considered intolerant.
- Age 22 or above
- Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote 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
Contraindications:
- Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
- Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
- Any condition or procedure that has compromised neurological control of the upper airway
- Patients who are unable or do not have the necessary assistance to operate the patient remote
- Patients who are pregnant or plan to become pregnant
- Patients who will require magnetic resonance imaging (MRI)
- Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system.
Additional exclusions for study purposes only:
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Inspire® UAS System Inspire® UAS System This is a single-arm study; all participants will be implanted with the Inspire® UAS System.
- Primary Outcome Measures
Name Time Method Long-term Device-Related SAEs 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 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 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.
- Secondary Outcome Measures
Name Time Method Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians 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.
Trial Locations
- Locations (14)
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Pennsylvania, Division of Sleep Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University and Hospital
🇺🇸Philadelphia, Pennsylvania, United States
The University of Alabama at Birmingham Medical Center
🇺🇸Birmingham, Alabama, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
South Miami Hospital
🇺🇸Miami, Florida, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University Hospitals
🇺🇸Cleveland, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Kentucky Research Group
🇺🇸Louisville, Kentucky, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States