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

• ClinicalTrials.gov Identifier: NCT02413970
• Recruitment Status: Active, not recruiting
• First Posted: April 10, 2015
• Last Update Posted: July 7, 2020
• Sponsor: Inspire Medical Systems, Inc.
• Information provided by (Responsible Party): Inspire Medical Systems, Inc.

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

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

More Information

• Responsible Party: Inspire Medical Systems, Inc.
• ClinicalTrials.gov Identifier: NCT02413970
• Other Study ID Numbers: 2014-001
• First Posted: April 10, 2015
• 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:

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases