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Compensation: Varies

Number of Visits: 1

127 Participants Needed

Inspire Therapy for Obstructive Sleep Apnea

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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.

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 data supports the effectiveness of the Inspire Therapy for Obstructive Sleep Apnea treatment?

Research shows that the Inspire Therapy, which stimulates the hypoglossal nerve to keep the airway open, significantly reduces the number of breathing interruptions during sleep and improves sleep quality for people with moderate to severe obstructive sleep apnea. Patients using this treatment have shown a reduction in sleep apnea severity and reported better daytime alertness, with high adherence to the therapy over time.¹ ² ³ ⁴ ⁵

Is Inspire Therapy for Obstructive Sleep Apnea safe for humans?

Inspire Therapy for Obstructive Sleep Apnea has been shown to be a safe treatment option, with studies reporting no serious adverse events and high adherence to therapy. However, there have been instances of device component malfunctions that required revision surgery.¹ ³ ⁵ ⁶ ⁷

How does the Inspire Therapy treatment for obstructive sleep apnea differ from other treatments?

Inspire Therapy is unique because it uses a device to stimulate the hypoglossal nerve, which helps keep the airway open during sleep, unlike traditional treatments that modify airway structures or use continuous positive airway pressure (CPAP). This approach is particularly beneficial for patients who cannot tolerate CPAP.¹ ² ³ ⁴ ⁵

Research Team

Gwen Gimmestad

Principal Investigator

Inspire Medical Systems, Inc.

Eligibility Criteria

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.

See 4 more

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.

See 8 more

Timeline

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)

Treatment Details

Interventions

Inspire® UAS System

Trial OverviewThe 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.

Participant Groups

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 Clinic Near You

Who Is Running the Clinical Trial?

Inspire Medical Systems, Inc.

Lead Sponsor

Trials

Recruited

6,800+

Findings from Research

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]