Upper Airway Stimulation for Obstructive Sleep Apnea

Recruiting at 7 trial locations

Overseen By Mike Swierzewski, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Inspire Medical Systems, Inc.

Disqualifiers: Central apneas, Pregnancy, Terminal illness, others

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

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of the Inspire Upper Airway Stimulation System for young adults with moderate to severe obstructive sleep apnea (OSA). It targets individuals who have not found success with other treatments, such as CPAP machines or surgeries. Participants will have a device implanted to maintain an open airway during sleep and will be monitored for five years. Those aged 18-21 who have tried other OSA treatments and are willing to have the device implanted may be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in OSA treatment.

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 Upper Airway Stimulation System is safe for pediatric subjects with obstructive sleep apnea?

Research has shown that the Inspire Upper Airway Stimulation (UAS) System is generally safe for treating obstructive sleep apnea (OSA). Studies indicate that this treatment can reduce the severity of OSA and enhance both sleep quality and overall quality of life.

One study specifically found that upper airway stimulation is safe and effective for teenagers, including those with Down syndrome. This suggests the treatment is well-tolerated by younger individuals, similar to those in the Pediatric Post-Approval Registry.

Additionally, the FDA has already approved the Inspire UAS System for adults, demonstrating a strong safety record. While children might respond differently, current data supports the treatment's safety in reducing sleep apnea symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Inspire Upper Airway Stimulation System is unique because it offers a new approach to treating moderate to severe obstructive sleep apnea (OSA) in young adults. Unlike traditional treatments like CPAP machines, which continuously push air through a mask to keep airways open, Inspire uses a surgically implanted device that stimulates airway muscles, preventing collapse and improving airflow during sleep. This method can be more comfortable for patients who struggle with CPAP masks, and it provides an alternative for those who have not found relief with existing options. Researchers are excited because this system could significantly enhance quality of life for individuals with OSA who need more effective and tolerable treatment solutions.

What evidence suggests that the Inspire Upper Airway Stimulation System is effective for obstructive sleep apnea?

Research has shown that the Inspire Upper Airway Stimulation System effectively treats moderate to severe obstructive sleep apnea (OSA). Studies have found that this treatment reduces the severity of OSA and improves sleep quality. Patients report an enhanced quality of life after using this system. One study noted significant improvements in both measurable factors, such as the frequency of breathing interruptions, and personal experiences, such as how rested patients feel. Overall, the Inspire System is considered a safe and effective way to manage OSA. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;

Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;

Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline (pre-implant)

Baseline data collection before the implant procedure

1 week

1 visit (in-person)

Implant Activation

Activation of the Inspire UAS System 1 month post-implant

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Inspire Upper Airway Stimulation System

How Is the Trial Designed?

Group I: Registry Population Experimental Treatment 1 Intervention

Pediatric subjects (age 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation System for the treatment of moderate to severe obstructive sleep apnea (OSA)

Who Is Running the Clinical Trial?

Inspire Medical Systems, Inc.

Lead Sponsor

Trials

14

Recruited

6,800+

Citations

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Reduction in severity of obstructive sleep apnea. • Preserved sleep quality. • Improved subjective quality of life. • Potential improvement in ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1308659

Upper-Airway Stimulation for Obstructive Sleep Apnea We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28561345/

Outcome after one year of upper airway stimulation for ... Conclusion: This study supported that UAS is a safe and effective treatment option for patients with OSA in routine clinical practice. Level of evidence: 4.

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

Publications Conclusion: Upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea. Read ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02907398

NCT02907398 | Adherence and Outcome of Upper Airway ... Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA ... Similar effect of hypoglossal nerve stimulation for obstructive sleep apnea in 5 disease ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04457154

NCT04457154 | Pediatric Post-Approval Registry This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway ...

7. inspiresleep.com inspiresleep.com/en-us/

Inspire Sleep Apnea Innovation - Obstructive Sleep Apnea ... Inspire® therapy is a mask-free solution for people with obstructive sleep apnea who have tried and struggled with CPAP. No mask. No hose. Just sleep.™

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9026239/

Evaluation of Upper Airway Stimulation for Adolescents With ... This study suggests that upper airway stimulation is a novel therapy that appears to be safe and effective for adolescent patients with Down syndrome and ...