CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 929 enrolled
Drug / intervention
Inspire Upper Airway Stimulation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01161420
NCT01161420Phase 3Completed
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Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea

Inspire Medical Systems, Inc.·interventional·Posted Jul 13, 2010·Updated Aug 25, 2017

In Brief

A Phase 3 clinical trial evaluating Inspire Upper Airway Stimulation System for Obstructive Sleep Apnea. Completed, enrolled 929 participants across 22 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesBelgium, France, Germany, Netherlands, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2010
Enrollment StartJul 1, 2010
Primary CompletionMar 1, 2013
Study CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.0 years ago

Interventions

Inspire Upper Airway Stimulation Systemdevice

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.