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Neurostimulation Device

Inspire Therapy for Obstructive Sleep Apnea

N/A
Waitlist Available
Research Sponsored by Inspire Medical Systems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Likely suffer moderate-to-severe OSA based on history and physical or have an established diagnosis of OSA (AHI >= 15) based on a prior sleep study
Age 22 or above
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post-implant
Awards & highlights

Study Summary

This trial will help researchers understand the long-term effects of Inspire therapy and whether it is safe and effective.

Who is the study for?
This trial is for adults aged 22 or older with moderate-to-severe Obstructive Sleep Apnea (OSA) who haven't had success with CPAP therapy due to non-compliance, discomfort, or persistent symptoms. Participants must be willing to have a stimulation device implanted and use a remote to activate it, as well as complete follow-up visits and home sleep studies.Check my eligibility
What is being tested?
The Inspire® UAS System is being tested for its long-term safety and effectiveness in treating OSA. This system stimulates airway muscles during sleep. The study involves having the device implanted and using it over an extended period while monitoring outcomes.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, changes in voice or tongue movement due to nerve stimulation, throat irritation or coughing when the device is activated, infection risks from surgery, and possible need for re-adjustment surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with moderate-to-severe sleep apnea.
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I am 22 years old or older.
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I am willing and able to give my consent for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post-implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Long-term Device-Related SAEs
Therapeutic procedure
Therapy Specific AEs
Secondary outcome measures
Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians
Other outcome measures
Change in AHI From Baseline to 3 Years
Change in ESS From Baseline to 12 Months
Change in FOSQ From Baseline to 12 Months
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Inspire® UAS SystemExperimental Treatment1 Intervention
This is a single-arm study; all participants will be implanted with the Inspire® UAS System.

Find a Location

Who is running the clinical trial?

Inspire Medical Systems, Inc.Lead Sponsor
11 Previous Clinical Trials
6,560 Total Patients Enrolled
Gwen GimmestadStudy DirectorInspire Medical Systems, Inc.
1 Previous Clinical Trials
5,000 Total Patients Enrolled

Media Library

Inspire® UAS System (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT02413970 — N/A
Obstructive Sleep Apnea Research Study Groups: Inspire® UAS System
Obstructive Sleep Apnea Clinical Trial 2023: Inspire® UAS System Highlights & Side Effects. Trial Name: NCT02413970 — N/A
Inspire® UAS System (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02413970 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What level of security does this treatment offer to individuals?

"This treatment has undergone rigorous testing and is now approved, so it earned a 3 on the safety scale."

Answered by AI

How many medical centers offer this research opportunity?

"To participate in this medical trial, potential patients need to visit either The University of Alabama at Birmingham Medical Center (Birmingham, AL), the University of Pennsylvania's Division of Sleep Medicine (Philadelphia, PA) or The Christ Hospital (Cincinnati oh). Additionally there are 14 other sites located throughout the United States."

Answered by AI

Is recruitment for this trial ongoing at present?

"Contrary to what is stated on clinicaltrials.gov, this trial has not recently been seeking candidates. It was first posted in May 2015 and last updated July 2020, yet there are 235 other medical studies that actively require participants right now."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
Connecticut
Florida
How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
The University of Alabama at Birmingham Medical Center
University of Southern California
South Miami Hospital
Other
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

I can't stand a mask on my face and my nose clogs up when I recline.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How may days do, I need to travel to NY? What time to, I need to be there? How much does it pay?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Inspire® Post-Approval Study / Protocol Number 2014-001
2015. "Inspire® Post-Approval Study / Protocol Number 2014-001". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02413970.
~11 spots leftby Mar 2025
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