- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413970
Inspire® Post-Approval Study / Protocol Number 2014-001
Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study Protocol Number 2014-001
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- The University of Alabama at Birmingham Medical Center
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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Florida
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Miami, Florida, United States, 33183
- South Miami Hospital
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Tampa, Florida, United States, 33606
- Tampa General Hospital
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Kansas
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Kansas City, Kansas, United States, 66160
- The University of Kansas Medical Center
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Kentucky
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Louisville, Kentucky, United States, 40218
- Kentucky Research Group
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New York
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New York, New York, United States, 10021
- Weill Cornell Medicine
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Ohio
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Cincinnati, Ohio, United States, 45219
- The Christ Hospital
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, United States, 44106
- University Hospitals
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania, Division of Sleep Medicine
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University and Hospital
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Pittsburgh, Pennsylvania, United States, 15219
- University of Pittsburgh Medical Center
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Inspire® UAS System
This is a single-arm study; all participants will be implanted with the Inspire® UAS System.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long-term Device-Related SAEs
Time Frame: 5 Years Post-Implant
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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.
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5 Years Post-Implant
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Therapy Specific AEs
Time Frame: 12 Months Post-Implant
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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.
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12 Months Post-Implant
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Long-term Therapy-Related AEs
Time Frame: 5 Years Post-Implant
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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.
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5 Years Post-Implant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians
Time Frame: 30 days post-implant
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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.
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30 days post-implant
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ESS From Baseline to 12 Months
Time Frame: Baseline and 12 Months
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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.
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Baseline and 12 Months
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Change in FOSQ From Baseline to 12 Months
Time Frame: Baseline and 12 Months
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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.
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Baseline and 12 Months
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Change in ODI From Baseline to 3 Years
Time Frame: Baseline and 3 Years
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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.
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Baseline and 3 Years
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Change in AHI From Baseline to 3 Years
Time Frame: Baseline and 3 Years
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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.
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Baseline and 3 Years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gwen Gimmestad, Inspire Medical Systems, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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