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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01161420

Public ClinicalTrials.gov record NCT01161420. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 5:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01161420
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Inspire Medical Systems, Inc.
Industry
Enrollment
929 participants

Conditions and interventions

Eligibility (public fields only)

Age range
22 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2010 (Actual)
Primary completion
Mar 2013 (Actual)
Completion
Apr 2017 (Actual)
Last update posted
Aug 25, 2017

2010 – 2017

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
15
Facility City State ZIP Site status
California Sleep Institute Palo Alto California 94303 —
Clinical Research Group of St. Petersburg, Inc. St. Petersburg Florida 33707 —
University of South Florida Tampa Florida 33606 —
Advanced ENT Atlanta Georgia 30342 —
Wayne State University / Detroit Medical Center Detroit Michigan 48201 —
Borgess Research Institute Portage Michigan 49048 —
North Memorial Medical Center Maple Grove Minnesota 55422 —
St. Cloud ENT Saint Cloud Minnesota 56303 —
University of Cincinnati Medical Center Cincinnati Ohio 45267 —
University Hospitals / Case Western Reserve Cleveland Ohio 44106 —
University of Pittsburgh Medical Center; Montefiore Oakland Pennsylvania 15219 —
Medical University of South Carolina Charleston South Carolina 29425 —
Sleep Medicine Associates of Texas Dallas Texas 75231 —
Swedish Health Services Seattle Washington 98122 —
Froedtert Memeorial Hospital Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01161420, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 25, 2017 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01161420 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →