Pediatric Post-Approval Registry
Inspire Pediatric Post-Approval Registry
1 other identifier
observational
60
1 country
8
Brief Summary
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2021
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
November 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
February 25, 2025
August 1, 2024
6 years
June 30, 2020
February 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluation of device and/or procedure related adverse events over time
relevant adverse events will be collected and reported
Implant through 5 years post-implant
Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time
Baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits). The Apnea Hypopnea Index (AHI) is the number of apnea and hypopnea events per hour of sleep. A lower AHI indicates less severe sleep apnea.
through 5 years post-implant
Secondary Outcomes (3)
Evaluation of improvement in Oxygen Desaturation Index (ODI) over time
through 5 years post-implant
Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time
through 5 years post-implant
Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time
through 5 years post-implant
Study Arms (1)
Registry Population
Pediatric subjects (age 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation System for the treatment of moderate to severe obstructive sleep apnea (OSA)
Interventions
Implant of the Inspire Upper Airway Stimulation System
Eligibility Criteria
Pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA).
You may qualify if:
- Subject is between 18 and 21 years of age;
- Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
- Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
- Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
- Subject has followed standard of care in considering all other alternative/adjunct therapies;
- Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
- Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry;
- Subject is willing and able to provide informed consent.
You may not qualify if:
- Subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
- Subject 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;
- Subject has any condition or procedure that has compromised neurological control of the upper airway;
- Subject is unable, or does not have the necessary assistance, to operate the patient remote;
- Subject is pregnant or plans to become pregnant;
- Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
- Subject has a terminal illness with life expectancy \< 12 months;
- Any other reason the investigator deems the subject is unfit for participation in the registry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Childrens Hospital of Colorado
Aurora, Colorado, 80045, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Duke University
Durham, North Carolina, 27705, United States
Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19406, United States
Children's Hospital of Pittsburgh
Sewickley, Pennsylvania, 15143, United States
University of Texas Southwestern/Children's Hospital of Dallas
Dallas, Texas, 75207, United States
Children's Hospital of the King's Daughters/East Virginia Medical School
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Post-Marketing Study
- Yes
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 7, 2020
Study Start
November 30, 2021
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
February 25, 2025
Record last verified: 2024-08