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

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ClinicalTrials.gov Identifier: NCT04801771
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : April 6, 2023
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Inspire Medical Systems, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Down Syndrome Obstructive Sleep Apnea Device: Inspire Upper Airway Stimulation (UAS) System Phase 2

Detailed 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.

Prior to implant subjects will be required to meet eligibility criteria, complete quality of life questionnaires and undergo neurocognitive testing (NCT) and expressive language sampling. Eligibility criteria will be determined via review of medical records, an in-lab polysomnography (sleep study), and a drug-induced sleep endoscopy (DISE).

After implant of the Inspire UAS System, subjects will undergo five (5) study visits. Four (4) of the visits will include an in-lab sleep study (PSG). Follow-up expressive language sampling and neurocognitive testing will be performed at 6 months post-implant. Follow-up quality of life questionnaires will be completed at 12 months post-implant.

Subjects will conclude their participation in the study at the end of their 12 month study visit.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea
Actual Study Start Date : June 24, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Subjects implanted with Inspire UAS System
Subjects who meet eligibility criteria will be implanted with the Inspire Upper Airway Stimulation (UAS) System.
 Device: 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.
Other Name: Hypoglossal nerve stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Change in intelligence using the Kaufman Brief Intelligence Scale (KBIT-2) [ Time Frame: 6 Months post-implant ]
    Change in the Intelligence Quotient Standard Score of at least 0.5 standard deviation from baseline

  2. Change in attention using the Wechsler Intelligence Scale [ Time Frame: 6 Months post-implant ]
    Change in Cancellation scaled score of at least 0.5 standard deviation from baseline

  3. Change in processing speed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: 6 Months post-implant ]
    Change in RTIFMDRT and RTIFMDMT raw scores of at least 0.5 standard deviation from baseline

  4. Change in executive functioning using the Delis-Kaplan Executive Functioning System (DKEFS) [ Time Frame: 6 Months post-implant ]
    Change in Category Functioning scaled score of at least 0.5 standard deviation from baseline

  5. Change in learning and memory using the Cambridge Neuropsychological Test Automated Battery - Paired Associates Learning [ Time Frame: 6 Months post-implant ]
    Change in PAL-TEA raw score of at least 0.5 standard deviation from baseline

  6. Change in language using Expressive Language Sampling [ Time Frame: 6 Months post-implant ]
    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


Secondary Outcome Measures :
  1. Rate of procedure and device-related adverse events [ Time Frame: Implant through 12 Months post-implant ]
    Procedure and device-related adverse events will be collected in order to profile the safety of hypoglossal nerve stimulation in adolescents. Number and percent of procedure and device-related adverse events will be reported

  2. Change in Obstructive Sleep Apnea (OSA) [ Time Frame: 3, 6, 12 Months post-implant ]
    Change in sleep apnea will be measured using standard in-lab PSG measures including oxygen level, partial and complete airway obstruction, and arousals. Improvement will be defined as a 50% or more decrease in AHI.

  3. Change in quality of life as measured by OSA-18 and ESS-CHAD questionnaires [ Time Frame: 12 months post-implant ]
    Quality of life improvements will be measured using the OSA-18 and ESS-CHAD. Mean scores for each questionnaire will be reported at baseline and 12 months post-implant.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04801771


Contacts
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Contact: Mike Swierzewski, MS 612-325-9723 michaelswierzewski@inspiresleep.com
Contact: Gwen Gimmestad 763-392-9966 gwengimmestad@inspiresleep.com

Locations
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United States, Georgia
Children's Healthcare of Atlanta/ Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30329
Contact: Nikhila Raol, MD       Nikhila.p.raol@emory.edu   
Contact: Saria Matthews, CRC       saria.matthews@emory.edu   
United States, Massachusetts
Massachusetts General Hospital (Mass Eye & Ear Infirmary) Recruiting
Boston, Massachusetts, United States, 02114
Contact: Odeta Dyrmishi, MPA       Odeta_Dyrmishi@meei.harvard.edu   
Principal Investigator: Chris Hartnick, MD         
Sub-Investigator: Brian Skotko, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ashley B Williams       WILLIAMSAB@chop.edu   
Principal Investigator: Lisa M Elden, MD         
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Allison Tobey, MD       allison.tobey@chp.edu   
Contact: Amber Shaffer, PhD    412-692-6874    shafferad@upmc.edu   
United States, Texas
University of Texas Southwestern/Children's Hospital of Dallas Recruiting
Dallas, Texas, United States, 75207
Contact: Ron Mitchell, MD       ron.mitchell@UTSouthwestern.edu   
Contact: Francesca Chambers       francesca.chambers@childrens.com   
United States, Virginia
Children's Hospital of the King's Daughters/East Virginia Medical School Recruiting
Norfolk, Virginia, United States, 32507
Contact: Cristina Baldassari, MD       cristina.baldassari@chkd.org   
Contact: Laura Stone, RN, BSN, CCRC    757-388-6238    stonelj@evms.edu   
Sponsors and Collaborators
Inspire Medical Systems, Inc.
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Christopher Hartnick, MD The Massachusetts Eye and Ear Infirmary
More Information
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Responsible Party: Inspire Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT04801771    
Other Study ID Numbers: 2020-003
1U01DC019279-01 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: April 6, 2023
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Inspire Medical Systems, Inc.:
Hypoglossal nerve stimulation
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Down Syndrome
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn