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
|Condition or disease||Intervention/treatment||Phase|
|Down Syndrome Obstructive Sleep Apnea||Device: Inspire Upper Airway Stimulation (UAS) System||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
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
|Contact: Mike Swierzewski, MSfirstname.lastname@example.org|
|Contact: Gwen Gimmestademail@example.com|
|United States, Georgia|
|Children's Healthcare of Atlanta/ Emory University School of Medicine||Recruiting|
|Atlanta, Georgia, United States, 30329|
|Contact: Nikhila Raol, MD Nikhila.firstname.lastname@example.org|
|Contact: Saria Matthews, CRC email@example.com|
|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 firstname.lastname@example.org|
|Contact: Amber Shaffer, PhD 412-692-6874 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Laura Stone, RN, BSN, CCRC 757-388-6238 firstname.lastname@example.org|
|Principal Investigator:||Christopher Hartnick, MD||The Massachusetts Eye and Ear Infirmary|