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Идёт набор NCT07113288

Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study

— Наблюдательное Obstructive Sleep Apnea (OSA)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Inspire® UAS System.
Кому может быть актуально
Состояния в реестре: Obstructive Sleep Apnea (OSA). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Inspire UAS High AHI/High BMI Post-Approval Study

Обзор

The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.

Подробное описание

This post-approval study is a condition of FDA approval and will collect long-term safety and effectiveness data on an expanded population that includes patients with very severe obstructive sleep apnea (65\<AHI≤100 events/hr), as well as those with a higher BMI (32\<BMI≤40 kg/m2). Participants will be implanted with a commercially available Inspire UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.

Вмешательства

  • Устройство Inspire® UAS System
    Participants will be implanted with a commercially available Inspire® UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.

Первичные конечные точки

  • Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability) [Срок оценки: 5 years post-implant]
Вторичные конечные точки (5)
  • Change in Apnea Hypopnea Index Over Time [Срок оценки: 5 years post-implant]
  • Body Mass Index [Срок оценки: 5 years post-implant]
  • Change in Oxygen Desaturation Index (ODI) Over Time [Срок оценки: 5 years post-implant]
  • Change in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) Over Time [Срок оценки: 5 years post-implant]
  • Change in Epworth Sleepiness Scale (ESS) Over Time [Срок оценки: 5 years post-implant]

Критерии участия

Критерии включения

  • Subject is at least 18 years of age;
  • Subject has a diagnosis of severe OSA (65 ≤ AHI ≤ 100) based on a recent sleep study (within 12 months) OR Subject has a diagnosis of moderate to severe OSA (15≤AHI≤100) AND a baseline Body Mass Index of 32<BMI≤40 kg/m2;
  • Subject has documented failure of, or intolerance to, positive airway pressure treatments (such as CPAP or BPAP machines; NOTE: PAP failure is defined as an inability to eliminate OSA (AHI > 15 despite PAP usage). PAP intolerance is defined as the inability to use PAP (> 5 nights per week, 4 hours of usage per night) or unwillingness to use PAP (e.g. patient returns the PAP system after attempting to use it).
  • 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 study;
  • 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) based on a recent sleep study (within 12 months);
  • 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 study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 5 центров
  • Colorado ENT & Allergy — Colorado Springs
  • Florida Sleep Specialists — Bradenton
  • Rush University Medical Center — Chicago
  • University of Kansas Medical Center — Kansas City
  • University of Rochester — Rochester

Идентификаторы

NCT: NCT07113288 · 2023-005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗