Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)

NCT01161420 | Completed Phase 3 Results DMC

• 1 other identifier: Inspire 4
• Study Type: interventional
• Target: 929
• Locations: 5 countries
• Sites: 22

Brief Summary

The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of the hypoglossal nerve. Study objectives include demonstrating that the Inspire system improves key indices of sleep apnea in a pre-specified percentage of patients.

Conditions

Obstructive Sleep Apnea

Keywords

tongue; surgery; neurostimulation; hypoglossal nerve; upper airway stimulation

Outcome Measures

Primary Outcomes (3)

• Apnea Hypopnea Index

  Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up.

  12 months

• Oxygen Desaturation Index

  Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy ODI responder was defines as a subject who experienced at least a 25% reduction in ODI from baseline.

  12 months

• Safety

  The primary safety objective of this pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.

  12 months

Secondary Outcomes (5)

• AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study

  12 Months

• Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects

  12 months

• Change in FOSQ From Baseline to 12 Months

  Baseline and 12 months

• Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months

  Baseline and 12 months

• Percentage Sleep Time at SaO2 < 90%

  12 months

Study Arms (1)

Inspire Therapy

EXPERIMENTAL

Inspire Upper Airway Stimulation System, is a permanent, implantable therapy device, which consists of three implantable components: IPG, stimulation lead, and a sensing lead. In additional the patient receives a remote to activate the therapy.

Device: Inspire Upper Airway Stimulation System

Interventions

Inspire Upper Airway Stimulation System DEVICE

Inspire Upper Airway Stimulation System, is a permanent, implantable therapy device, which consists of three implantable components: IPG, stimulation lead, and a sensing lead. In additional the patient receives a remote to activate the therapy.

Also known as: Inspire, UAS, Inspire Therapy

Inspire Therapy

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
• Have failed or have not tolerated CPAP treatment
• Willing and capable of providing informed consent
• Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
• Willing and capable to return for all follow-up visits and sleep studies, including the evaluation procedures and filling out the questionnaires

You may not qualify if:

• Body Mass Index limits
• Surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat
• Significant co-morbidities making the patient unable or inappropriate to participate in the trial

Sponsors & Collaborators

• Inspire Medical Systems, Inc.: lead

Study Sites (22)

California Sleep Institute

Palo Alto, California, 94303, United States

Location

Clinical Research Group of St. Petersburg, Inc.

St. Petersburg, Florida, 33707, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Advanced ENT

Atlanta, Georgia, 30342, United States

Location

Wayne State University / Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Borgess Research Institute

Portage, Michigan, 49048, United States

Location

North Memorial Medical Center

Maple Grove, Minnesota, 55422, United States

Location

St. Cloud ENT

Saint Cloud, Minnesota, 56303, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

University Hospitals / Case Western Reserve

Cleveland, Ohio, 44106, United States

Location

University of Pittsburgh Medical Center; Montefiore

Oakland, Pennsylvania, 15219, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Sleep Medicine Associates of Texas

Dallas, Texas, 75231, United States

Location

Swedish Health Services

Seattle, Washington, 98122, United States

Location

Froedtert Memeorial Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Deparment of Pulmonology Head and Neck Surgery, Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

Central Hospital University of Bordeaux

Bordeaux, France

Location

Hospital Foch

Paris, France

Location

Krankenhaus Bethanien Solingen

Solingen, DE, Germany

Location

St. Franziskus Hospital

Cologne, Germany

Location

Universitäts-HNO-Klinik Mannheim

Mannheim, Germany

Location

St. Lucas Andreas Ziekenhuis

Amsterdam, Netherlands

Location

Related Publications (4)

• Johnson MD, Dweiri YM, Cornelius J, Strohl KP, Steffen A, Suurna M, Soose RJ, Coleman M, Rondoni J, Durand DM, Ni Q. Model-based analysis of implanted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea. Sleep. 2021 Apr 27;44(44 Suppl 1):S11-S19. doi: 10.1093/sleep/zsaa269.

  PMID: 33647987 DERIVED

• Yu JL, Younes M. Relation between arousability and outcome of upper airway stimulation in the Stimulation for Apnea Reduction (STAR) Trial. J Clin Sleep Med. 2021 Apr 1;17(4):797-801. doi: 10.5664/jcsm.9050.

  PMID: 33295277 DERIVED

• Op de Beeck S, Wellman A, Dieltjens M, Strohl KP, Willemen M, Van de Heyning PH, Verbraecken JA, Vanderveken OM, Sands SA; STAR Trial Investigators. Endotypic Mechanisms of Successful Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2021 Mar 15;203(6):746-755. doi: 10.1164/rccm.202006-2176OC.

  PMID: 32970962 DERIVED

• Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659.

  PMID: 24401051 DERIVED

Related Links

• Click here for more information about the intervention

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

Results Point of Contact

• Title: Quan Ni
• Organization: Inspire Medical Systems

quanni@inspiresleep.com

763-205-7968

Study Officials

• Quan Ni, Ph.D.

  Inspire Medical Systems, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 13, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2017
• Last Updated: August 25, 2017
• Results First Posted: December 15, 2014

Record last verified: 2017-07

Locations

BE (1); FR (2); DE (3); NL (1); US (15)