Inspire® Post-Approval Study / Protocol Number 2014-001

March 6, 2024 updated by: Inspire Medical Systems, Inc.

Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study Protocol Number 2014-001

The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.

Study Overview

Status

Active, not recruiting

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

Interventional

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35294
        • The University of Alabama at Birmingham Medical Center
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Florida
      • Miami, Florida, United States, 33183
        • South Miami Hospital
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Kentucky Research Group
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Division of Sleep Medicine
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University and Hospital
      • Pittsburgh, Pennsylvania, United States, 15219
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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:
  • Inspire® therapy

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
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.
5 Years Post-Implant
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.
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.
5 Years Post-Implant

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
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.
30 days post-implant

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 Months
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.
Baseline and 12 Months
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.
Baseline and 3 Years
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.
Baseline and 3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gwen Gimmestad, Inspire Medical Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimated)

April 10, 2015

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

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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