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NCT01161420 · ClinicalTrials.gov registry record · Phase 3
Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
A Phase 3 study, sponsored by Inspire Medical Systems.
- Completed
- Registry status
- Phase 3
- Development phase
- 929
- Enrollment target
NCT01161420: Completed Phase 3 study, sponsored by Inspire Medical Systems.
NCT01161420 is a Phase 3 study that has completed, run by Inspire Medical Systems. The registered enrollment target is 929 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01161420, a Phase 3 study, has completed, sponsored by Inspire Medical Systems.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 929 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Inspire Upper Airway Stimulation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 929 participants |
| Start Date | 2010-07 |
| Est. Completion | 2017-04 |
| Phase | Phase 3 |
What the finished NCT01161420 record still lists
NCT01161420 is an interventional study that assigns participants to a tested intervention. The registered 929 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 1 intervention - of which Inspire Upper Airway Stimulation System is the first listed.
NCT01161420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01161420 about?
NCT01161420 is a clinical study titled "Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)". 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...
What is the current status of trial NCT01161420?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 929 participants. The study started on 2010-07. Estimated completion is 2017-04.
What interventions are being tested in trial NCT01161420?
The interventions under investigation include: Inspire Upper Airway Stimulation System (DEVICE).
Who is sponsoring clinical trial NCT01161420?
This trial is sponsored by Inspire Medical Systems, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01161420's enrollment target sits among peer trials
929 339th of 2000 higher than 1,662 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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