Pediatric Down Syndrome Post-Approval Study

Overview

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.

Interventions

• 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

Primary outcome measures

• Safety Outcome Measure - Procedure and Device-related Adverse events [Time frame: Implant through 5 Years]
• Effectiveness Outcome Measure - Comparison of Baseline and Annual Apnea-Hypopnea Index (AHI) [Time frame: Baseline and Annually through 5 Years post-implant]

Secondary outcome measures (3)

• Effectiveness Outcome Measure - Comparison of Baseline, 6 month, and Annual Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) [Time frame: Baseline, 6 months, and annually through 5-year post-implant]
• Effectiveness Outcome Measure - Comparison of Baseline and Annual Percent Time Oxygen Saturation < 90% (T90) [Time frame: Baseline and Annually through 5-year post-implant]
• Effectiveness Outcome Measure - Comparison of Baseline and Annual Oxygen Desaturation Index (ODI) [Time frame: Baseline and Annually through 5 years post-implant]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 6 centers

• Phoenix Children's Hospital — Phoenix
• Children's Hospital Orange County — Orange
• University of South Florida Morsani College of Medicine — Tampa
• Northwell Cohen Children's Hospital — Queens
• Cleveland Clinic Foundation — Cleveland
• Baylor College of Medicine/ Texas Children's Hospital — Houston

Identifiers

NCT: NCT06851338 · 2023-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗