Inspire Therapy for Obstructive Sleep Apnea

Not currently recruiting at 13 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inspire Medical Systems, Inc.

Disqualifiers: Central apneas, Pregnancy, MRI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather more long-term data on the safety and effectiveness of Inspire therapy for people with obstructive sleep apnea (OSA). The treatment uses the Inspire® UAS System, a device implanted to keep the airway open during sleep. It targets individuals with moderate-to-severe OSA who have struggled with CPAP therapy due to discomfort or persistent symptoms. Participants should be prepared to have the device implanted and use a remote to control it. Those experiencing frequent issues with CPAP and OSA may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to understanding the long-term benefits of an innovative treatment for OSA.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Inspire® UAS System is safe for obstructive sleep apnea?

Research has shown that the Inspire® Upper Airway Stimulation (UAS) System is generally safe for adults with obstructive sleep apnea who cannot use traditional treatments like positive airway pressure (PAP). Studies have found that people with moderate-to-severe sleep apnea usually tolerate the device well.

Inspire therapy uses a small device to help keep the airway open during sleep. Testing has confirmed its safety in everyday situations. Most users do not experience serious side effects. Some may feel pain or discomfort around the device placement, but these issues are usually manageable.

Overall, the Inspire UAS System maintains a strong safety record, especially for those who have difficulty with other treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Inspire® UAS System is unique because it offers a new approach to treating obstructive sleep apnea (OSA) by using an implantable device to stimulate the airway muscles. Unlike traditional options like CPAP machines, which require wearing a mask during sleep, this system works by sending mild electrical pulses to keep the airway open. Researchers are excited about this treatment because it can improve patient comfort and adherence, potentially providing a more effective and less invasive solution for those who struggle with existing therapies.

What evidence suggests that the Inspire® UAS System is effective for obstructive sleep apnea?

Research has shown that the Inspire® UAS System effectively reduces symptoms of obstructive sleep apnea (OSA). One study found it significantly decreased the number of breathing interruptions by about 20 times per hour in the short term and 16 times per hour in the long term. Another study reported that people with moderate to severe OSA felt less sleepy and experienced a better quality of life after using the device. Patients also highly prefer the Inspire system, with 91% choosing it over traditional CPAP machines. Overall, these findings suggest that Inspire therapy can greatly improve sleep and quality of life for people with OSA. ^{1 6 7 8 9}

Who Is on the Research Team?

Gwen Gimmestad

Principal Investigator

Inspire Medical Systems, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

at will Desiring and able to have stimulation hardware implanted and use a patient remote to activate the stimulation as desired.

I have been diagnosed with moderate-to-severe sleep apnea.

I cannot use CPAP therapy effectively due to issues like discomfort or side effects.

Exclusion Criteria

You have a medical device that could be affected by the Inspire system.

My throat structure does not allow for a certain sleep apnea treatment.

I have a condition affecting my ability to control my upper airway.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-implant Qualification

Pre-implant screening and implant qualification process including in-lab PSG, surgical consultation, and drug-induced sleep endoscopy

4 weeks

Multiple visits (in-person)

Implantation and Initial Follow-up

Implantation of Inspire® UAS System and initial follow-up for procedure- and device-related adverse events

12 months

Regular visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness, including in-lab PSG and home sleep tests

5 years

Annual visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Inspire® UAS System

Trial Overview 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.

How Is the Trial Designed?

Group I: Inspire® UAS System Experimental Treatment 1 Intervention

This is a single-arm study; all participants will be implanted with the Inspire® UAS System.

Who Is Running the Clinical Trial?

Inspire Medical Systems, Inc.

Lead Sponsor

Trials

14

Recruited

6,800+

Published Research Related to This Trial

Upper airway stimulation (UAS) using the Inspire II implant is an effective treatment for obstructive sleep apnea (OSA) by stimulating the hypoglossal nerve to prevent airway obstruction and improve airflow.

Clinical studies show that UAS significantly enhances sleep quality and respiratory metrics in patients with moderate-to-severe OSA, making it a viable long-term treatment option with low associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Airway Stimulation Therapy. Green, KK., Woodson, BT.[2017]

Hypoglossal nerve stimulation (HNS) with Inspire is a cost-effective treatment for patients with moderate to severe obstructive sleep apnoea who cannot tolerate CPAP, showing an incremental cost-effectiveness ratio of £17,989 per quality-adjusted life-year (QALY) gained.

Patients receiving HNS are expected to gain more quality-adjusted life years (12.72 QALYs) compared to those receiving no treatment (11.15 QALYs), indicating that HNS not only improves health outcomes but is also a financially viable option for the NHS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breathing Synchronised Hypoglossal Nerve Stimulation with Inspire for Untreated Severe Obstructive Sleep Apnoea/Hypopnoea Syndrome: A Simulated Cost-Utility Analysis from a National Health Service Perspective. Blissett, DB., Steier, JS., Karagama, YG., et al.[2021]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130008S090b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Direct assessments of patient preference between Inspire. UAS and CPAP were done in the ADHERE registry, showing 91% of patients preferred.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8269272/

Effect of Upper Airway Stimulation in Patients with Obstructive ... Therapeutic UAS reduced OSA severity, sleepiness symptoms, and improved quality of life among participants with moderate-to-severe OSA.

3. professionals.inspiresleep.com professionals.inspiresleep.com/en-us/publications/

Publications Conclusion: Across a multi‐institutional study, UAS implant continues to show significant improvement in subjective and objective OSA outcomes. This analysis ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0954611124003019

Hypoglossal nerve stimulation for obstructive sleep apnea ... The Inspire device significantly improved, reducing the apnea-hypopnea index (AHI) by −20.14 events/h in the short term and −15.91 events/h in the long term. It ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9694893/

Quality of Life Impact of Hypoglossal Nerve Stimulation ... In conclusion, patients with moderate/severe OSA implanted with the Inspire® device showed a positive IQoL. Keywords: quality of life, obstructive sleep apnea, ...

6. inspiresleep.com inspiresleep.com/en-us/safety-information/

Important Safety Information | Inspire Sleep Apnea ... Understand the safety criteria for Inspire® therapy, including AHI range, MRI considerations, BMI limitations, and other potential risks.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/p130008b.pdf

summary of safety and effectiveness data (ssed) For the first co-primary endpoint, the study defined a responder to the Inspire®. UAS therapy as a patient with least a 50% reduction in the AHI compared to the.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02675816

NCT02675816 | Inspire® Upper Airway Stimulation System The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4576333/

Upper Airway Stimulation for Obstructive Sleep Apnea Upper airway stimulation (UAS) has been shown to be safe and effective in participants with moderate-to-severe OSA, who could not adhere to positive airway ...