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

Description

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.

Conditions

Down Syndrome, Obstructive Sleep Apnea

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Down Syndrome
Intervention / Treatment

-

Contacts and Locations

Atlanta

Children's Healthcare of Atlanta/ Emory University School of Medicine, Atlanta, Georgia, United States, 30329

Boston

Massachusetts General Hospital (Mass Eye & Ear Infirmary), Boston, Massachusetts, United States, 02114

Cincinnati

Cincinnati Childrens Hospital, Cincinnati, Ohio, United States, 45229

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Pittsburgh

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15224

Dallas

University of Texas Southwestern/Children's Hospital of Dallas, Dallas, Texas, United States, 75207

Norfolk

Children's Hospital of the King's Daughters/East Virginia Medical School, Norfolk, Virginia, United States, 32507

Madison

University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, United States, 53705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

10 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Inspire Medical Systems, Inc.,

Christopher Hartnick, MD, PRINCIPAL_INVESTIGATOR, The Massachusetts Eye and Ear Infirmary

Study Record Dates

2025-03-31