Pediatric Down Syndrome Post-Approval Study

Not Applicable

Recruiting

• Conditions: Pediatric Obstructive Sleep Apnea; Down Syndrome (DS)

• Registration Number: NCT06851338
• Lead Sponsor: Inspire Medical Systems, Inc.

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.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Primary Completion: 2030-05
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety Outcome Measure - Procedure and Device-related Adverse events	Implant through 5 Years	Procedure-related and Device-related adverse events will be summarized by seriousness and severity. No formal hypothesis will be tested.
Effectiveness Outcome Measure - Comparison of Baseline and Annual Apnea-Hypopnea Index (AHI)	Baseline and Annually through 5 Years post-implant	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.

Secondary Outcome Measures

Name	Time	Method
Effectiveness Outcome Measure - Comparison of Baseline and Annual Percent Time Oxygen Saturation < 90% (T90)	Baseline and Annually through 5-year post-implant	Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.
Effectiveness Outcome Measure - Comparison of Baseline, 6 month, and Annual Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)	Baseline, 6 months, and annually through 5-year post-implant	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.
Effectiveness Outcome Measure - Comparison of Baseline and Annual Oxygen Desaturation Index (ODI)	Baseline and Annually through 5 years post-implant	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.

Trial Locations

Locations (6)

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