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

Primary Purpose

Obstructive Sleep Apnea

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspire® UAS System
Sponsored by
Inspire Medical Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA, Neurostimulation, Hypoglossal nerve, Tongue, Upper airway stimulation, Surgery

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Alabama at Birmingham Medical Center
  • University of Southern California
  • South Miami Hospital
  • Tampa General Hospital
  • The University of Kansas Medical Center
  • Kentucky Research Group
  • Weill Cornell Medicine
  • The Christ Hospital
  • University Hospitals
  • Cleveland Clinic Foundation
  • University of Pennsylvania, Division of Sleep Medicine
  • Thomas Jefferson University and Hospital
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Inspire® UAS System

Arm Description

This is a single-arm study; all participants will be implanted with the Inspire® UAS System.

Outcomes

Primary Outcome Measures

Long-term Device-Related SAEs
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
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
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

Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians
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.

Full Information

First Posted
March 30, 2015
Last Updated
January 24, 2023
Sponsor
Inspire Medical Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02413970
Brief Title
Inspire® Post-Approval Study / Protocol Number 2014-001
Official Title
Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study Protocol Number 2014-001
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2015 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inspire Medical Systems, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA, Neurostimulation, Hypoglossal nerve, Tongue, Upper airway stimulation, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Inspire UAS
Masking
None (Open Label)
Allocation
N/A
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspire® UAS System
Arm Type
Other
Arm Description
This is a single-arm study; all participants will be implanted with the Inspire® UAS System.
Intervention Type
Device
Intervention Name(s)
Inspire® UAS System
Other Intervention Name(s)
Inspire® therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Long-term Device-Related SAEs
Description
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.
Time Frame
5 Years Post-Implant
Title
Therapy Specific AEs
Description
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.
Time Frame
12 Months Post-Implant
Title
Long-term Therapy-Related AEs
Description
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.
Time Frame
5 Years Post-Implant
Secondary Outcome Measure Information:
Title
Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians
Description
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.
Time Frame
30 days post-implant
Other Pre-specified Outcome Measures:
Title
Change in ESS From Baseline to 12 Months
Description
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.
Time Frame
Baseline and 12 Months
Title
Change in FOSQ From Baseline to 12 Months
Description
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.
Time Frame
Baseline and 12 Months
Title
Change in ODI From Baseline to 3 Years
Description
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.
Time Frame
Baseline and 3 Years
Title
Change in AHI From Baseline to 3 Years
Description
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.
Time Frame
Baseline and 3 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwen Gimmestad
Organizational Affiliation
Inspire Medical Systems, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The University of Alabama at Birmingham Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
South Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania, Division of Sleep Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University and Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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