🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT04801771
Active, not recruiting Not applicable

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

NCT04801771 · tracked via the Priya Life Science USA tracker
Sponsor
Inspire Medical Systems, Inc.
Phase
Not applicable
Started
2021-06-24
Last updated
2026-08-25

Condition(s) studied

Down SyndromeObstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Inspire Upper Airway Stimulation (UAS) System

Inspire Upper Airway Stimulation (UAS) System: The Inspire UAS System is an implantable device that provides hypoglossal nerve stimulation for the treatment of obstructive sleep apnea.

Study summary

This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.

Eligibility

Sex
ALL
Min age
10 Years
Max age
21 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (8)

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

More Inspire Medical Systems, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04801771 on ClinicalTrials.gov ↗ ← All trials in the USA