Hypoglossal nerve stimulation for improving cognition and language in young people with Down syndrome and sleep apnea

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

This study is testing if a new device that stimulates a nerve can help young people with Down syndrome and sleep apnea improve their thinking and speaking skills.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 10 Years to 21 Years
• Sex: All
• Sponsor: Inspire Medical Systems, Inc. (Industry-sponsored)
• Locations: 8 sites (Atlanta, Georgia and 7 other locations)
• Trial ID: NCT04801771 on ClinicalTrials.gov

What this trial studies

This interventional study aims to evaluate the effects of the Inspire Upper Airway Stimulation (UAS) System on cognition and expressive language in adolescents and young adults aged 10-21 with Down syndrome and moderate to severe obstructive sleep apnea. The study will follow 57 participants for 12 months post-implant, assessing changes through neurocognitive testing, expressive language sampling, and quality of life questionnaires. Participants will undergo a series of in-lab sleep studies and assessments to measure the impact of the treatment. Eligibility criteria include a prior adenotonsillectomy and severe obstructive sleep apnea not effectively treated by other means.

Who should consider this trial

Good fit: Ideal candidates are adolescents and young adults aged 10-21 with Down syndrome and severe obstructive sleep apnea who have undergone adenotonsillectomy.

Not a fit: Patients who do not have Down syndrome or those with mild obstructive sleep apnea may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance cognitive function and language skills in young individuals with Down syndrome and sleep apnea.

How similar studies have performed: While the approach of using hypoglossal nerve stimulation is gaining interest, this specific application in the context of Down syndrome and cognitive improvement is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Diagnosis of Down syndrome
* Age 10-21 years
* Prior adenotonsillectomy
* Severe OSA (AHI \> 10, AHI \< 50, no more than 25% AHI attributable to central events) based on prior in-lab PSG performed after adenotonsillectomy and within 18 months of enrollment
* Approval from at least two of the three physician reviewers based upon the results of a routine drug-induced sleep endoscopy (DISE) having occurred within 12 months of enrollment
* Subjects must have either tracheotomy or be ineffectively treated with CPAP due to non-compliance, discomfort, un-desirable side effects, persistent symptoms despite compliance use, or refusal to use the device
* Children and their parents/guardians must be willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative PSG, and questionnaire completion
* Children's parents/guardians must complete a questionnaire confirming that their child is capable of communicating feelings of pain or discomfort. They must also confirm they are able to assess their child for adverse effects related to device implantation
* Children and their parents/guardians must be proficient in English

Exclusion Criteria:

* Body mass index (BMI) above the 95th percentile for subject's age
* Circumferential airway collapse at the level of the velopharynx observed during DISE
* Other medical conditions resulting in medical instability (eg. congestive heart failure, recent open heart surgery, immunosuppression, or chronic lung disease or aspiration)
* Presence of another medical condition requiring future magnetic resonance imaging (MRI) of the chest
* Patients with another implantable device which could interact unintentionally with the Inspire system
* Any contraindication for general anesthesia
* History of bleeding or clotting disorders and those on blood thinning or NSAID medications for the week prior to implantation surgery. Subjects will be asked to refrain from the use of NSAIDS for two weeks after implantation or any revision surgeries
* Subject is currently taking muscle relaxant medication
* Life expectancy less than 12 months
* Subject's inability to communicate pain or discomfort to their caretaker/parent, based on parental or investigator assessment
* Nonverbal candidates will be excluded due to an inability to complete testing procedures including expressive language sampling
* Subjects with a co-occurring diagnosis of autism spectrum disorder
* Subjects that have a positive β-HCG
* Subjects deemed unfit for participation by the investigator for any other reason

Where this trial is running

Atlanta, Georgia and 7 other locations

• Children's Healthcare of Atlanta/ Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
• Massachusetts General Hospital (Mass Eye & Ear Infirmary) — Boston, Massachusetts, United States (Recruiting)
• Cincinnati Childrens Hospital — Cincinnati, Ohio, United States (Recruiting)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
• University of Texas Southwestern/Children's Hospital of Dallas — Dallas, Texas, United States (Recruiting)
• Children's Hospital of the King's Daughters/East Virginia Medical School — Norfolk, Virginia, United States (Recruiting)
• University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Christopher Hartnick, MD — The Massachusetts Eye and Ear Infirmary
• Study coordinator: Mike Swierzewski, MS

Conditions Down Syndrome; Obstructive Sleep Apnea; Hypoglossal nerve stimulation