Hypoglossal Nerve Stimulation for Sleep Apnea in Down Syndrome

Recruiting at 5 trial locations

Overseen By Gwen Gimmestad, VP Clinical

Age: < 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?

The trial aims to test the safety and effectiveness of Inspire therapy, a treatment for severe obstructive sleep apnea, in young people with Down syndrome. It focuses on adolescents aged 13-18 who struggle with severe sleep apnea and have not benefited from other treatments like CPAP machines. Those with Down syndrome who experience frequent sleep disruptions due to severe sleep apnea might be suitable candidates for this trial. Participants will receive a device that stimulates the hypoglossal nerve to help keep their airways open during sleep. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for severe sleep apnea.

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 prior data suggests that the Inspire therapy is safe for adolescents and young adults with Down syndrome?

Research has shown that Inspire therapy is safe for individuals with Down syndrome who have sleep apnea. Studies in adults with Down syndrome found that the treatment is safe and that individuals continue using it. A small study on teenagers with Down syndrome also suggested the treatment is safe and effective. The FDA has already approved Inspire therapy for adults unable to use other sleep apnea treatments, supporting its safety. Overall, current evidence indicates that Inspire therapy is generally safe for people with Down syndrome. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Inspire therapy is unique because it uses hypoglossal nerve stimulation to treat severe obstructive sleep apnea in individuals with Down syndrome. Unlike traditional treatments such as CPAP machines, which require wearing a mask during sleep, Inspire therapy is a surgically implanted device that works from inside the body to keep the airway open. Researchers are excited about this treatment as it offers a more comfortable and potentially more effective alternative for patients who struggle with or do not benefit from CPAP therapy.

What evidence suggests that Inspire therapy is effective for sleep apnea in Down syndrome?

Studies have shown that Inspire therapy, which uses gentle nerve stimulation, effectively treats obstructive sleep apnea (OSA) in patients who cannot tolerate traditional treatments like positive airway pressure (PAP). Research indicates that this therapy is safe and effective for teenagers with Down syndrome. A case study involving a young child with Down syndrome and sleep apnea suggested similar positive outcomes. The therapy stimulates the nerve controlling the tongue, helping to keep the airway open during sleep. This approach has shown promising results in improving sleep patterns for people with Down syndrome and severe sleep apnea. Participants in this trial will undergo the Inspire Upper Airway Stimulation (UAS) implant to evaluate its effectiveness in this specific population. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Inspire therapy

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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 (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]

Citations

1.

accessdata.fda.gov

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

Inspire UAS is used in adult patients 22 years of age and older who have been confirmed to fail or cannot tolerate positive airway pressure (PAP).

2.

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 ...

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aasm.org

aasm.org/fda-approves-inspire-therapy-for-pediatric-patients-with-down-syndrome/

FDA approves Inspire therapy for pediatric patients with ...

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4.

massgeneralbrigham.org

massgeneralbrigham.org/en/about/newsroom/press-releases/down-syndrome-sleep-apnea-study

Case Study of 4-Year-Old with Down Syndrome and Sleep ...

Case Study of 4-Year-Old with Down Syndrome and Sleep Apnea Suggests Hypoglossal Nerve Stimulation Can Be Effective Treatment at Young Ages.

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cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/08/NCT02344108/Prot_000.pdf

a pilot study to evaluate safety and

effectiveness of hypoglossal nerve implantation in the treatment of obstructive sleep apnea in adolescents with Down Syndrome. • Any deviations from the ...

6.

professionals.inspiresleep.com

professionals.inspiresleep.com/en-us/indications-and-contraindications/

Indications & Contraindications

Inspire Upper Airway Stimulation (UAS) is used to treat a subset of patients with moderate to severe Obstructive Sleep Apnea (OSA).

7.

jcsm.aasm.org

jcsm.aasm.org/doi/10.5664/jcsm.11452

Adults with Down syndrome and obstructive sleep apnea ...

This study demonstrates that hypoglossal nerve stimulation in adults with Down syndrome is safe and efficacious and yields excellent adherence to therapy.