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Pediatric Down Syndrome Post-Approval Study

RecruitingNAAges 13 Years - 18 YearsAllInspire Medical Systems, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Patient has been diagnosed with Down syndrome; 2. Patient is 13-18 years of age; 3. Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of โ‰ฅ 10 and โ‰ค 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG); 4. Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance; 5. Patient is contraindicated for, or not effectively treated by, adenotonsillectomy; 6. Treatment of patient's OSA has followed standard of care in considering all other alternative/adjunctive therapies; 7. Patient, and their parents/guardians, is willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab sleep studies (PSGs), and questionnaire completion. Exclusion Criteria: 1. Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI); 2. 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; 3. Patient has any condition or procedure that has compromised neurological control of the upper airway; 4. Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote; 5. Patient is pregnant or plans to become pregnant; 6. Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system; 7. Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling; 8. Patient has a terminal illness with life expectancy of less than 12 months; 9. Any other reason the investigator deems the patient is unfit for participation in the study.
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What it tests

  • Hypoglossal Nerve Stimulation
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Where

6 sites
Phoenix Children's Hospital
Phoenix, United States
Children's Hospital Orange County
Orange, United States
University of South Florida Morsani College of Medicine
Tampa, United States
Northwell Cohen Children's Hospital
Queens, United States
Cleveland Clinic Foundation
Cleveland, United States
Baylor College of Medicine/ Texas Children's Hospital
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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