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

NCT ID: NCT01161420

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 929 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2017-04-30

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.

Detailed Description

The STAR trial is a multicenter, prospective trial that includes a randomized controlled therapy withdrawal study. The primary and secondary endpoint data were collected during an in-laboratory sleep study 12 months after the device implant and were compared against the baseline sleep studies. Following the 12-month visit, 46 consecutive responding subjects were randomized 1:1 to either a therapy maintenance group (ON group) or a therapy withdrawal group (OFF group). A subsequent sleep study of the two randomized groups was conducted and results were compared between the two groups. In addition, quality of life questionnaires were administered at baseline and at the 12-month visit to further assess the effectiveness of Inspire therapy.

The STAR trial was conducted at 15 clinical sites in the United States and 7 in Europe. Of the 126 implanted subjects in the STAR trial, 87 or 69% were implanted in the United States. The remaining 39 subjects or 31% were implanted in Europe.

The STAR trial subjects were evaluated prior to implant to ensure the following: 1) that their pre-implant AHI (as scored during an in-laboratory sleep study prior to implant) was between 20 and 50 events per hour, 2) that any AHI contribution from central or mixed sleep apnea was less than 25%, 3) that subjects did not have primarily lateral OSA (defined as limited sleep apnea when lying on their side), and 4) that the subjects did not have a complete concentric collapse at the level of the soft palate while observed during a drug-induced sleep endoscopy (DISE).

After successful pre-implant screening, the subjects were implanted with the Inspire system. The subjects were allowed to recover for 1 month following surgery, at which time a second in-laboratory sleep study was conducted without activating the Inspire device. The results of this 1-month sleep study were averaged with the results of the pre-implant sleep study, and the average is defined as the subject's baseline.

The Inspire device is programmable in order to optimize a subject's response to therapy. The initial device settings are programmed in an office setting. Additional adjustments are made during an overnight sleep study whereby real time review of the polysomnogram (PSG) is available to aid in device setting adjustments during the 2 and 6-month visit.

At the 12-month in-laboratory sleep study, no device adjustments were allowed as this sleep study was the primary endpoint sleep study. Furthermore, no device adjustments were allowed at the 13-month sleep study which was the randomized controlled therapy withdrawal sleep studies.

Blinding was not possible during the study since the stimulation therapy evokes a physiological response in the subjects. However, the primary endpoints were based on the objective measures of AHI and oxygen desaturation index (ODI) which were collected during an overnight sleep study using PSG. The sleep studies were all scored by an independent core lab in order to minimize assessment bias. Furthermore, the sleep study results, as well as all other clinical results, were 100% source data verified by the Inspire clinical monitoring team.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inspire Therapy

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.

Group Type: EXPERIMENTAL

Inspire Upper Airway Stimulation System

Intervention Type: 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.

Interventions

Inspire Upper Airway Stimulation System

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.

Intervention Type: DEVICE

Other Intervention Names

Inspire; UAS; Inspire Therapy

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inspire Medical Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quan Ni, Ph.D.

Role: STUDY_DIRECTOR

Inspire Medical Systems, Inc.

Locations

California Sleep Institute

Palo Alto, California, United States

Clinical Research Group of St. Petersburg, Inc.

St. Petersburg, Florida, United States

University of South Florida

Tampa, Florida, United States

Advanced ENT

Atlanta, Georgia, United States

Wayne State University / Detroit Medical Center

Detroit, Michigan, United States

Borgess Research Institute

Portage, Michigan, United States

North Memorial Medical Center

Maple Grove, Minnesota, United States

St. Cloud ENT

Saint Cloud, Minnesota, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

University Hospitals / Case Western Reserve

Cleveland, Ohio, United States

University of Pittsburgh Medical Center; Montefiore

Oakland, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Sleep Medicine Associates of Texas

Dallas, Texas, United States

Swedish Health Services

Seattle, Washington, United States

Froedtert Memeorial Hospital

Milwaukee, Wisconsin, United States

Deparment of Pulmonology Head and Neck Surgery, Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

Central Hospital University of Bordeaux

Bordeaux, , France

Hospital Foch

Paris, , France

Krankenhaus Bethanien Solingen

Solingen, DE, Germany

St. Franziskus Hospital

Cologne, , Germany

Universitäts-HNO-Klinik Mannheim

Mannheim, , Germany

St. Lucas Andreas Ziekenhuis

Amsterdam, , Netherlands

Countries

United States; Belgium; France; Germany; Netherlands

References

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.

Reference Type: DERIVED

PMID: 33647987 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33295277 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32970962 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24401051 (View on PubMed)

Related Links

http://www.inspiresleep.com

Click here for more information about the intervention

Other Identifiers

Inspire 4

Identifier Type: -

Identifier Source: org_study_id