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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Inspire® UAS System Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 127 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Inspire UAS
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  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:

Contraindications:

  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

Information from the National Library of Medicine

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


Locations
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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
University Hospitals
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
Sponsors and Collaborators
Inspire Medical Systems, Inc.
Investigators
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Study Director: Gwen Gimmestad Inspire Medical Systems, Inc.
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Responsible Party: Inspire Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT02413970    
Other Study ID Numbers: 2014-001
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Keywords provided by Inspire Medical Systems, Inc.:
OSA
Neurostimulation
Hypoglossal nerve
Tongue
Upper airway stimulation
Surgery
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases