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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
Must not have
Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
Any condition or procedure that has compromised neurological control of the upper airway
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post-implant
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My throat structure does not allow for a certain sleep apnea treatment.
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I have a condition affecting my ability to control my upper airway.
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Less than 25% of my sleep apneas are central or mixed.
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I do not have a psychiatric condition that would stop me from following study requirements.
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I am pregnant or planning to become pregnant.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Long-term Device-Related SAEs
Therapeutic procedure
Therapy Specific AEs
Secondary study objectives
Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians
Other study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
12 Previous Clinical Trials
6,605 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
~3 spots leftby Mar 2025
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