Clinical trial NCT06851338: Pediatric Down Syndrome Post-Approval Study
Official title: Pediatric Down Syndrome Post-Approval Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Obstructive Sleep Apnea
Down Syndrome (DS)
Keywords: Pediatrics
OSA
Down Syndrome
Pediatrics OSA
Obstructive Sleep Apnea
Long-term follow-up
Post Approval Study
PAS
Lead sponsor: Inspire Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 ≥ 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:

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.

Primary outcomes:
measure: Safety Outcome Measure - Procedure and Device-related Adverse events
timeFrame: Implant through 5 Years
measure: Effectiveness Outcome Measure - Comparison of Baseline and Annual Apnea-Hypopnea Index (AHI)
timeFrame: Baseline and Annually through 5 Years post-implant
Secondary outcomes:
measure: Effectiveness Outcome Measure - Comparison of Baseline, 6 month, and Annual Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)
timeFrame: Baseline, 6 months, and annually through 5-year post-implant
measure: Effectiveness Outcome Measure - Comparison of Baseline and Annual Percent Time Oxygen Saturation < 90% (T90)
timeFrame: Baseline and Annually through 5-year post-implant
measure: Effectiveness Outcome Measure - Comparison of Baseline and Annual Oxygen Desaturation Index (ODI)
timeFrame: Baseline and Annually through 5 years post-implant
Other outcomes:
measure: Ancillary Outcome Measure - Therapy Usage
timeFrame: 6 Months and Annually through 5 years post-implant
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Orange
country: United States
facility: Children's Hospital Orange County
state: California
city: Tampa
country: United States
facility: University of South Florida Morsani College of Medicine
state: Florida
city: Queens
country: United States
facility: Northwell Cohen Children's Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine/ Texas Children's Hospital
state: Texas
Study officials:
References: