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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DC019279-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects implanted with Inspire UAS System | Experimental | Subjects who meet eligibility criteria will be implanted with the Inspire Upper Airway Stimulation (UAS) System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of procedure and device-related adverse events | 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 | Implant through 12 Months post-implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Hartnick, MD | The Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta/ Emory University School of Medicine | Atlanta | Georgia | 30329 | United States | ||
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Hypoglossal Nerve Stimulation
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| Change in Obstructive Sleep Apnea (OSA) |
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, 6, 12 Months post-implant |
| Change in quality of life as measured by OSA-18 and ESS-CHAD questionnaires | 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. | 12 months post-implant |
| Massachusetts General Hospital (Mass Eye & Ear Infirmary) |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Cincinnati Childrens Hospital | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Texas Southwestern/Children's Hospital of Dallas | Dallas | Texas | 75207 | United States |
| Children's Hospital of the King's Daughters/East Virginia Medical School | Norfolk | Virginia | 32507 | United States |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53705 | United States |
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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