Pediatric Down Syndrome Post-Approval Study

NCT06851338 | Recruiting FDA Device

• 1 other identifier: 2023-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• Effectiveness Outcome Measure - Comparison of Baseline and Annual Percent Time Oxygen Saturation < 90% (T90)

  Baseline and Annually through 5-year post-implant

• Effectiveness Outcome Measure - Comparison of Baseline and Annual Oxygen Desaturation Index (ODI)

  Baseline and Annually through 5 years post-implant

Other Outcomes (1)

• Ancillary Outcome Measure - Therapy Usage

  6 Months and Annually through 5 years post-implant

Study Arms (1)

Pediatric subjects with Down syndrome undergoing Inspire UAS Implant

EXPERIMENTAL

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

Interventions

Hypoglossal Nerve Stimulation DEVICE

Implant of Inspire Upper Airway Stimulation (UAS) system for treatment of obstructive sleep apnea (OSA) in the pediatric down syndrome population

Also known as: Inspire Upper Airway Stimulation (UAS) System

Pediatric subjects with Down syndrome undergoing Inspire UAS Implant

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• Patient is contraindicated for, or not effectively treated by, adenotonsillectomy;
• Treatment of patient's OSA has followed standard of care in considering all other alternative/adjunctive therapies;
• 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.

You may not qualify if:

• 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;
• Patient is pregnant or plans to become pregnant;
• Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system;
• Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling;
• Patient has a terminal illness with life expectancy of less than 12 months;
• Any other reason the investigator deems the patient is unfit for participation in the study.

Sponsors & Collaborators

• Inspire Medical Systems, Inc.: lead

Study Sites (6)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

NOT YET RECRUITING

Children's Hospital Orange County

Orange, California, 92868, United States

NOT YET RECRUITING

University of South Florida Morsani College of Medicine

Tampa, Florida, 33602, United States

NOT YET RECRUITING

Northwell Cohen Children's Hospital

Queens, New York, 11040, United States

NOT YET RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Baylor College of Medicine/ Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Down Syndrome; Sleep Apnea, Obstructive

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Angela Chapin, Sr. Clinical Study Manager

CONTACT

763.392.7222; angelachapin@inspiresleep.com

Gwen Gimmestad, VP Clinical

CONTACT

763.392.9966; gwengimmestad@inspiresleep.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Post-Marketing Study: Yes

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)