Pediatric Down Syndrome Post-Approval Study

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.

Study Overview

• Status: Recruiting
• Conditions: Down Syndrome (DS); Pediatric Obstructive Sleep Apnea
• Intervention / Treatment: Device: Hypoglossal Nerve Stimulation

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Chapin, Sr. Clinical Study Manager; Phone Number: 763.392.7222; Email: angelachapin@inspiresleep.com
• Study Contact Backup: Name: Gwen Gimmestad, VP Clinical; Phone Number: 763.392.9966; Email: gwengimmestad@inspiresleep.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Not yet recruiting
      • Phoenix Children's Hospital
      • Contact: Chase Beckerman; Email: cbeckerman@phoenixchildrens.com
      • Contact: Richard Law, MD
  • California
    • Orange, California, United States, 92868
      • Not yet recruiting
      • Children's Hospital Orange County
      • Contact: Eric Rodriguez; Email: Eric.Rodriguez@choc.org
      • Contact: Chana Chin, MD
  • Florida
    • Tampa, Florida, United States, 33602
      • Not yet recruiting
      • University of South Florida Morsani College of Medicine
      • Contact: Alex Czachor; Email: aczachor@tgh.org
      • Contact: Abhay Sharma, MD
  • New York
    • Queens, New York, United States, 11040
      • Not yet recruiting
      • Northwell Cohen Children's Hospital
      • Contact: Virginia Mullooly; Email: GMullool@northwell.edu
      • Contact: Patrick Scheffler, MD
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Not yet recruiting
      • Cleveland Clinic Foundation
      • Contact: Alex Piczer; Email: PICZERA@ccf.org
      • Contact: Vaishal Shah, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine/ Texas Children's Hospital
      • Contact: Sadaf Batla; Email: sxbatla@texaschildrens.org
      • Contact: Mary F Musso, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: 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 Names: Inspire Upper Airway Stimulation (UAS) System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ancillary Outcome Measure - Therapy Usage	Therapy usage, reported as hours per week and averaged into hours per night, will be used to quantify device use and adherence over time (6M, annually 1-5 years). Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.	6 Months and Annually through 5 years post-implant

Collaborators and Investigators

• Sponsor: Inspire Medical Systems, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: OSA; Obstructive Sleep Apnea; Pediatrics; Down Syndrome; Long-term follow-up; PAS; Pediatrics OSA; Post Approval Study
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Disease; Neurobehavioral Manifestations; Respiration Disorders; Sleep Wake Disorders; Congenital Abnormalities; Abnormalities, Multiple; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Intellectual Disability; Chromosome Disorders; Syndrome; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Down Syndrome
• Other Study ID Numbers: 2023-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes