Recruiting NCT04457154

Pediatric Post-Approval Registry

— Observational Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Inspire Upper Airway Stimulation System.
Who it may be relevant to: Registry conditions: Obstructive Sleep Apnea. Basic parameters: 18 years — 21 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Inspire Pediatric Post-Approval Registry

Overview

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.

Detailed description

Subjects will be recruited in accordance with the approved Inspire UAS indication for use and will only include those subjects who are within the new age indication (18-21 years of age). Implanted subjects must meet the registry eligibility criteria. Those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures.

This registry will collect safety and effectiveness data on 60 implanted subjects at a minimum of 5 qualified clinical centers in the United States.

Study data will be collected at the following timepoints:

Baseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant

1, 2, 3, 4, 5 years post-implant

Interventions

Device Inspire Upper Airway Stimulation System
Implant of the Inspire Upper Airway Stimulation System

Primary outcome measures

Evaluation of device and/or procedure related adverse events over time [Time frame: Implant through 5 years post-implant]
Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time [Time frame: through 5 years post-implant]

Secondary outcome measures (3)

Evaluation of improvement in Oxygen Desaturation Index (ODI) over time [Time frame: through 5 years post-implant]
Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time [Time frame: through 5 years post-implant]
Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time [Time frame: through 5 years post-implant]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

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

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

United States · 8 centers

Childrens Hospital of Colorado — Aurora
Children's Healthcare of Atlanta — Atlanta
Duke University — Durham
Cincinnati Childrens Hospital — Cincinnati
Children's Hospital of Philadelphia — Philadelphia
Children's Hospital of Pittsburgh — Sewickley
University of Texas Southwestern/Children's Hospital of Dallas — Dallas
Children's Hospital of the King's Daughters/East Virginia Medical School — Norfolk

Identifiers

NCT: NCT04457154 · 2020-002

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗