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

NCT02413970 | Active Not Recruiting

• 1 other identifier: 2014-001
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Obstructive Sleep Apnea

Keywords

OSA; Neurostimulation; Hypoglossal nerve; Tongue; Upper airway stimulation; Surgery

Outcome Measures

Primary Outcomes (3)

• 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.

  5 Years Post-Implant

• 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.

  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.

  5 Years Post-Implant

Secondary Outcomes (1)

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

  30 days post-implant

Other Outcomes (4)

• Change in ESS From Baseline to 12 Months

  Baseline and 12 Months

• Change in FOSQ From Baseline to 12 Months

  Baseline and 12 Months

• Change in ODI From Baseline to 3 Years

  Baseline and 3 Years

Study Arms (1)

Inspire® UAS System

OTHER

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

Device: Inspire® UAS System

Interventions

Inspire® UAS System DEVICE

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.

Also known as: Inspire® therapy

Inspire® UAS System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Inspire Medical Systems, Inc.: lead

Study Sites (14)

The University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35294, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

South Miami Hospital

Miami, Florida, 33183, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kentucky Research Group

Louisville, Kentucky, 40218, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania, Division of Sleep Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University and Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Gwen Gimmestad

  Inspire Medical Systems, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Inspire UAS

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 10, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-03

Locations

US (14)