Pediatric Post-Approval Registry

Официальное название

Inspire Pediatric Post-Approval Registry

Обзор

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.

Подробное описание

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.

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

Вмешательства

• Устройство Inspire Upper Airway Stimulation System
  Implant of the Inspire Upper Airway Stimulation System

Первичные конечные точки

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

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 8 центров

• 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

Идентификаторы

NCT: NCT04457154 · 2020-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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