Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatment inspire upper airway stimulation system
Phase phase 3
Sponsor Inspire Medical Systems, Inc.
Start date July 2010
End date March 2013
Trial size 929 participants
Trial identifier NCT01161420, Inspire 4

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
inspire upper airway stimulation system Inspire
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.

Primary Outcomes

Measure
Apnea Hypopnea Index
time frame: 12 months
Oxygen Desaturation Index
time frame: 12 months
Safety
time frame: 12 months

Secondary Outcomes

Measure
AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study
time frame: 12 Months
Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects
time frame: 12 months
Change in FOSQ From Baseline to 12 Months
time frame: Baseline and 12 months
Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months
time frame: Baseline and 12 months
Percentage Sleep Time at SaO2 < 90%
time frame: 12 months

Eligibility Criteria

Male or female participants at least 22 years old.

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

Additional Information

Official title Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Inspire Medical Systems, Inc..