Hypoglossal Nerve Stimulation for Sleep Apnea in Down Syndrome

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Inspire Medical Systems, Inc.

Disqualifiers: Central apneas, Pregnancy, Terminal illness, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.

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 study team or your doctor.

What data supports the effectiveness of the treatment Inspire therapy for sleep apnea in Down syndrome?

Research shows that hypoglossal nerve stimulation, which is part of Inspire therapy, significantly reduces sleep apnea events in both adolescents and adults with Down syndrome. Patients experienced improvements in symptoms and reduced need for other treatments like tracheotomy, indicating its effectiveness. ^{1 2 3 4 5}

Is hypoglossal nerve stimulation safe for people with Down syndrome and sleep apnea?

Hypoglossal nerve stimulation has been used in both children and adults with Down syndrome and sleep apnea, showing low surgery-related problems and good device use. Some patients reported improvements in symptoms, and one even had better blood sugar control. ^{1 2 3 6 7}

How does the treatment Inspire therapy differ from other treatments for sleep apnea in Down syndrome?

Inspire therapy is unique because it involves an implantable device that stimulates the hypoglossal nerve (a nerve that controls tongue movement) to prevent airway blockage during sleep, unlike other treatments like continuous positive airway pressure (CPAP) or tracheotomy, which are often poorly tolerated by patients with Down syndrome. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for adolescents and young adults aged 13-18 with Down syndrome who suffer from severe sleep apnea. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

I have severe sleep apnea diagnosed by a recent sleep study.

I cannot have or did not improve after adenotonsillectomy.

My sleep apnea treatment has followed all standard recommendations.

Exclusion Criteria

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

My throat structure won't allow for a specific sleep apnea treatment.

Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Implantation

Participants undergo implant of the Inspire Upper Airway Stimulation (UAS) system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after implantation

5 years

Multiple visits (in-person and virtual) annually

Treatment Details

Interventions

• Inspire therapy (Device)

Trial Overview The study is evaluating the ongoing safety and effectiveness of a treatment called Inspire therapy, which uses hypoglossal nerve stimulation to help manage severe sleep apnea in young individuals with Down syndrome.

Participant Groups

Group I: Pediatric subjects with Down syndrome undergoing Inspire UAS Implant Experimental Treatment 1 Intervention

This study is a prospective, multi-center, single-arm study of pediatric subjects (age 13-18) with Down syndrome who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) system for the treatment of severe obstructive sleep apnea (OSA).

Who Is Running the Clinical Trial?

Inspire Medical Systems, Inc.

Lead Sponsor

Trials

14

Recruited

6,800+

Findings from Research

Hypoglossal nerve stimulation significantly reduces the apnea-hypopnea index by an average of 17.43 events per hour in adolescents with Down syndrome and obstructive sleep apnea, indicating its efficacy as a treatment option.

The procedure also improves quality of life, as shown by a significant reduction in the OSA-18 score, although the most common side effect reported was pain or discomfort in the tongue or mouth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation in adolescents with down syndrome and obstructive sleep apnea: A systematic review and meta-analysis. Liu, P., Kong, W., Fang, C., et al.[2022]

Hypoglossal nerve (HGN) stimulation is a safe and effective treatment for obstructive sleep apnea (OSA) in children with Down syndrome, with no long-term complications reported in a study of 20 participants aged 10-21 years.

The therapy resulted in an impressive median reduction of 85% in apnea-hypopnea index (AHI) after 2 months, along with significant improvements in quality of life as measured by the OSA-18 survey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on hypoglossal nerve stimulation in children with down syndrome and obstructive sleep apnea. Caloway, CL., Diercks, GR., Keamy, D., et al.[2020]

In a study of three adults with Down syndrome and severe obstructive sleep apnea (OSA), hypoglossal nerve stimulation showed significant reductions in apnea-hypopnea index (AHI) by 86%-100% at optimal settings, indicating its efficacy in managing OSA.

The procedure had low morbidity, and all patients reported improvements in symptoms, with one patient also experiencing better blood sugar control, suggesting additional health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation in three adults with down syndrome and severe obstructive sleep apnea. Li, C., Boon, M., Ishman, SL., et al.[2020]

The hypoglossal nerve stimulator was successfully implanted in a pediatric patient with Down syndrome and severe obstructive sleep apnea (OSA), leading to a significant reduction in apnea events from 48.5 to 3.4 events per hour.

This treatment was well tolerated by the patient, allowing for the removal of a long-standing tracheotomy five months post-implantation, demonstrating its efficacy as an alternative to continuous positive airway pressure in children who cannot tolerate conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal Nerve Stimulator Implantation in an Adolescent With Down Syndrome and Sleep Apnea. Diercks, GR., Keamy, D., Kinane, TB., et al.[2022]

Hypoglossal nerve stimulation was found to be safe and well tolerated in a case series of 6 adolescents with Down syndrome and severe obstructive sleep apnea (OSA), with an average usage of 5.6 to 10.0 hours per night.

The treatment resulted in a significant reduction in apnea hypopnea index (AHI) by 56% to 85% at 6- to 12-month follow-up, with four patients achieving an AHI of less than 5 events per hour, indicating effective management of OSA in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal Nerve Stimulation in Adolescents With Down Syndrome and Obstructive Sleep Apnea. Diercks, GR., Wentland, C., Keamy, D., et al.[2022]

Hypoglossal nerve stimulation (HNS) has shown promising results in treating moderate-to-severe obstructive sleep apnea (OSA), with follow-up studies indicating similar or improved apnea-hypopnea index (AHI) outcomes since the Inspire device's FDA approval in 2014.

The use of drug-induced sedation endoscopy (DISE) has emerged as a valuable tool for assessing patient eligibility for HNS, highlighting the importance of a coordinated approach between medical and surgical management for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights since FDA Approval of Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea. Strohl, MM., Yamauchi, M., Peng, Z., et al.[2022]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation in adolescents with down syndrome and obstructive sleep apnea: A systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Update on hypoglossal nerve stimulation in children with down syndrome and obstructive sleep apnea. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation in three adults with down syndrome and severe obstructive sleep apnea. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Hypoglossal Nerve Stimulator Implantation in an Adolescent With Down Syndrome and Sleep Apnea. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Hypoglossal Nerve Stimulation in Adolescents With Down Syndrome and Obstructive Sleep Apnea. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Insights since FDA Approval of Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea. [2022]

7. Switzerland 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. [2021]