Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-02-28
2030-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pediatric subjects with Down syndrome undergoing Inspire UAS Implant
This study is a prospective, multi-center, single-arm study of pediatric subjects (age 13-18) with Down syndrome who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) system for the treatment of severe obstructive sleep apnea (OSA).
Hypoglossal Nerve Stimulation
Implant of Inspire Upper Airway Stimulation (UAS) system for treatment of obstructive sleep apnea (OSA) in the pediatric down syndrome population
Interventions
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Hypoglossal Nerve Stimulation
Implant of Inspire Upper Airway Stimulation (UAS) system for treatment of obstructive sleep apnea (OSA) in the pediatric down syndrome population
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient is 13-18 years of age;
3. 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);
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
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.
13 Years
18 Years
ALL
No
Sponsors
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Inspire Medical Systems, Inc.
INDUSTRY
Responsible Party
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Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Orange County
Orange, California, United States
University of South Florida Morsani College of Medicine
Tampa, Florida, United States
Northwell Cohen Children's Hospital
Queens, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Baylor College of Medicine/ Texas Children's Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Richard Law, MD
Role: backup
Chana Chin, MD
Role: backup
Abhay Sharma, MD
Role: backup
Patrick Scheffler, MD
Role: backup
Vaishal Shah, MD
Role: backup
Mary F Musso, MD
Role: backup
Other Identifiers
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2023-002
Identifier Type: -
Identifier Source: org_study_id
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