Pediatric Down Syndrome Post-Approval Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorInspire Medical Systems, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient has been diagnosed with Down syndrome;
Patient is 13-18 years of age;
Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG);
Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance;
Disqualifiers
Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);
Patient has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
Patient has any condition or procedure that has compromised neurological control of the upper airway;
Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote;
Trial design
Design model
Single group
Treatments tested in this trial
Hypoglossal Nerve Stimulation
DeviceImplant of Inspire Upper Airway Stimulation (UAS) system for treatment of obstructive sleep apnea (OSA) in the pediatric down syndrome population
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Pediatric subjects with Down syndrome undergoing Inspire UAS ImplantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 Years2
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-implantSecondary outcomes
1
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-implant2
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-implant3
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.
Time frame
Baseline and Annually through 5 years post-implantOther outcomes
1
Ancillary Outcome Measure - Therapy Usage
Therapy usage, reported as hours per week and averaged into hours per night, will be used to quantify device use and adherence over time (6M, annually 1-5 years). Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.
Time frame
6 Months and Annually through 5 years post-implantSponsors and contacts
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Source ClinicalTrials.gov