The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.
This is a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow sixty (60) adolescents (13 - 18), with Down Syndrome and severe sleep apnea for 5-years after undergoing implant of the Inspire Upper Airway Stimulation (UAS) system. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatrics Down Syndrome population. Prior to implant subjects will be required to meet eligibility criteria that is based on an in-lab PSG, surgical consultation and drug induced sleep endoscopy, as well as other assessments. Subjects will also complete quality of life questionnaires. During the 5-year follow-up period, data will be collected at the time of implant, and at multiple follow-up visits through five years post-implant. At each of these visits, safety information (adverse events), sleep data, therapy usage, and quality of life will be collected. A total of sixty (60) subjects with even distribution across the age range will be implanted at a minimum of five (5) clinical centers in the US. Subjects will conclude their participation in the study at the end of their 5 year follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Implant of Inspire Upper Airway Stimulation (UAS) system for treatment of obstructive sleep apnea (OSA) in the pediatric down syndrome population
Phoenix Children's Hospital
Phoenix, Arizona, United States
NOT_YET_RECRUITINGChildren's Hospital Orange County
Orange, California, United States
NOT_YET_RECRUITINGUniversity of South Florida Morsani College of Medicine
Tampa, Florida, United States
Safety Outcome Measure - Procedure and Device-related Adverse events
Procedure-related and Device-related adverse events will be summarized by seriousness and severity. No formal hypothesis will be tested.
Time frame: Implant through 5 Years
Effectiveness Outcome Measure - Comparison of Baseline and Annual Apnea-Hypopnea Index (AHI)
The AHI will be collected at each sleep study. This effectiveness measure will be reported as a comparison of baseline and annual (1-5 year) AHI. Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.
Time frame: Baseline and Annually through 5 Years post-implant
Effectiveness Outcome Measure - Comparison of Baseline, 6 month, and Annual Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)
The ESS-CHAD will be completed at baseline, as well as 6 months and annually (1-5 years) post-implant. The ESS-CHAD score at baseline compared to the ESS-CHAD score at each annual study visit will be reported. Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.
Time frame: Baseline, 6 months, and annually through 5-year post-implant
Effectiveness Outcome Measure - Comparison of Baseline and Annual Percent Time Oxygen Saturation < 90% (T90)
Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.
Time frame: Baseline and Annually through 5-year post-implant
Effectiveness Outcome Measure - Comparison of Baseline and Annual Oxygen Desaturation Index (ODI)
The ODI will be collected during each sleep study. This effectiveness measure will be reported as a comparison of baseline and annual (1-5 year) ODI. Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.
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Northwell Cohen Children's Hospital
Queens, New York, United States
NOT_YET_RECRUITINGCleveland Clinic Foundation
Cleveland, Ohio, United States
NOT_YET_RECRUITINGBaylor College of Medicine/ Texas Children's Hospital
Houston, Texas, United States
RECRUITINGTime frame: Baseline and Annually through 5 years post-implant