Inspire® Post-Approval Study / Protocol Number 2014-001
NCT ID: NCT02413970
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
127 participants
INTERVENTIONAL
2015-05-31
2025-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Inspire® UAS System
This is a single-arm study; all participants will be implanted with the Inspire® UAS System.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Age 22 or above
4. Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote to activate the stimulation
5. Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
6. Willing and capable of providing informed consent
Exclusion Criteria
1. Central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI)
2. Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
3. Any condition or procedure that has compromised neurological control of the upper airway
4. Patients who are unable or do not have the necessary assistance to operate the patient remote
5. Patients who are pregnant or plan to become pregnant
6. Patients who will require magnetic resonance imaging (MRI)
7. Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system.
Additional exclusions for study purposes only:
1. Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
2. Has a terminal illness with life expectancy \< 12 months
3. Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
4. Any other reason the investigator deems subject is unfit for participation in the study
22 Years
ALL
No
Sponsors
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Inspire Medical Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gwen Gimmestad
Role: STUDY_DIRECTOR
Inspire Medical Systems, Inc.
Locations
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The University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
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
University of Pennsylvania, Division of Sleep Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University and Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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2014-001
Identifier Type: -
Identifier Source: org_study_id