Health Trials

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

Qualifiers

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

Treatments tested in this trial

  • Hypoglossal Nerve Stimulation

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

6
Arizona
Phoenix Children's Hospital85016, Phoenix United States
California
Children's Hospital Orange County92868, Orange United States
Florida
University of South Florida Morsani College of Medicine33602, Tampa United States
New York
Northwell Cohen Children's Hospital11040, Queens United States

Sponsors and collaborators

Inspire Medical Systems, Inc.

Lead sponsor

Source ClinicalTrials.gov