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

NCT04801771 | Active Not Recruiting Phase 3 DMC FDA Device

• 2 other identifiers: 2020-0031U01DC019279-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Down Syndrome; Obstructive Sleep Apnea

Keywords

Hypoglossal nerve stimulation

Outcome Measures

Primary Outcomes (6)

• Change in intelligence using the Kaufman Brief Intelligence Scale (KBIT-2)

  Change in the Intelligence Quotient Standard Score of at least 0.5 standard deviation from baseline

  6 Months post-implant

• Change in attention using the Wechsler Intelligence Scale

  Change in Cancellation scaled score of at least 0.5 standard deviation from baseline

  6 Months post-implant

• Change in processing speed using the Cambridge Neuropsychological Test Automated Battery (CANTAB)

  Change in RTIFMDRT and RTIFMDMT raw scores of at least 0.5 standard deviation from baseline

  6 Months post-implant

• Change in executive functioning using the Delis-Kaplan Executive Functioning System (DKEFS)

  Change in Category Functioning scaled score of at least 0.5 standard deviation from baseline

  6 Months post-implant

• Change in learning and memory using the Cambridge Neuropsychological Test Automated Battery - Paired Associates Learning

  Change in PAL-TEA raw score of at least 0.5 standard deviation from baseline

  6 Months post-implant

• Change in language using Expressive Language Sampling

  Change in % of unintelligible C-units, number of different word roots and mean length of C-units in morphemes of at least 0.5 standard deviation from baseline

  6 Months post-implant

Secondary Outcomes (3)

• Rate of procedure and device-related adverse events

  Implant through 12 Months post-implant

• Change in Obstructive Sleep Apnea (OSA)

  3, 6, 12 Months post-implant

• Change in quality of life as measured by OSA-18 and ESS-CHAD questionnaires

  12 months post-implant

Study Arms (1)

Subjects implanted with Inspire UAS System

EXPERIMENTAL

Subjects who meet eligibility criteria will be implanted with the Inspire Upper Airway Stimulation (UAS) System.

Device: Inspire Upper Airway Stimulation (UAS) System

Interventions

Inspire Upper Airway Stimulation (UAS) System DEVICE

The Inspire UAS System is an implantable device that provides hypoglossal nerve stimulation for the treatment of obstructive sleep apnea.

Also known as: Hypoglossal nerve stimulation

Subjects implanted with Inspire UAS System

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inspire Medical Systems, Inc.: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (8)

Children's Healthcare of Atlanta/ Emory University School of Medicine

Atlanta, Georgia, 30329, United States

Location

Massachusetts General Hospital (Mass Eye & Ear Infirmary)

Boston, Massachusetts, 02114, United States

Location

Cincinnati Childrens Hospital

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Texas Southwestern/Children's Hospital of Dallas

Dallas, Texas, 75207, United States

Location

Children's Hospital of the King's Daughters/East Virginia Medical School

Norfolk, Virginia, 32507, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Down Syndrome; Sleep Apnea, Obstructive

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Christopher Hartnick, MD

  The Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Hypoglossal Nerve Stimulation

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: March 17, 2021
• Study Start: June 24, 2021
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)