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Идёт набор NCT06332404

Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry

— Наблюдательное Obstructive Sleep Apnea Sleep Apnea Apnea

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: Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA).
Кому может быть актуально
Состояния в реестре: Obstructive Sleep Apnea, Sleep Apnea, Apnea. Базовые параметры: 18 лет — 99 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
Бельгия
Следующий шаг
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Официальное название

Hypoglossal Nerve Stimulation (HNS) Therapy in Patients With Obstructive Sleep Apnea (OSA): Belgian Registry

Обзор

Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved. The aim is to create a multi-center registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care in Belgium.

Подробное описание

Patients that are implanted with the Inspire system in Belgium will be invited to participate in the registry. Data will be collected from different routine clinical care visits over a period of 5 years post-implantation. All assessments of the registry are part of the standard clinical care. Data collection will include polysomnographic data, home sleep test data, therapy usage, device data and questionnaires (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire-30, Visual Analogue Scale (VAS) snoring.

Data will be collected from routine visits including: pre-implant, implant, activation, titration, follow-up (6, 12, 24, 36, 48 and 60 months post-implantation).

Вмешательства

  • Устройство Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)
    Hypoglossal nerve stimulation therapy

Первичные конечные точки

  • Delta apnea-hypopnea index (AHI) as measured by a polysomnography [Срок оценки: From baseline to 6, 12 and 60 months post-implantation]
Вторичные конечные точки (9)
  • % of patients that reach treatment success defined by a 50% reduction in AHI and an on therapy AHI of < 20 events/h OR an on therapy AHI of < 15 events/h [Срок оценки: At 6, 12 and 60 months post-implantation]
  • Therapy adherence defined by the amount of hours therapy usage per night. [Срок оценки: At 6, 12 and 60 months post-implantation]
  • Delta oxygen desaturation index (ODI) as measured by a polysomnography [Срок оценки: From baseline to 6, 12 and 60 months post-implantation]
  • Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire [Срок оценки: From baseline to 6, 12 and 60 months post-implantation]
  • Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire [Срок оценки: From baseline to 6, 12 and 60 months post-implantation]
  • Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire [Срок оценки: From baseline to 6, 12 and 60 months post-implantation]
  • Flow-derived site of collapse [Срок оценки: At 6, 12 and 60 months post-implantation]
  • Pathophysiological endotypes [Срок оценки: At 6, 12 and 60 months post-implantation]
  • New OSA severity metrics [Срок оценки: At 6, 12 and 60 months post-implantation]

Критерии участия

Критерии включения

Any patient implanted with or receiving the Inspire HNS system and who is able to give informed consent is eligible to participate in the registry. A patient is eligible for HNS implantation if he/she meets the following criteria:

  • At least 18 years old at the time of implantation
  • The patient suffers from moderate to severe OSA (15 events/h ≤ AHI ≤ 65 events/h)
  • The patient has failed, not tolerated or has a contraindication for continuous positive airway pressure (CPAP) and/or mandibular advancement device (MAD) therapy
  • Absence of complete concentric collapse of the level of the soft palate during Drug-Induced Sleep Endoscopy (DISE)

Критерии исключения

  • Body mass index (BMI) >32 kg/m².
  • Combined mixed and central AHI is more than 25% of the total AHI
  • Patients with complete concentric collapse at the level of the soft palate or any other anatomical deviation that could impede the proper functioning of HNS
  • Patients with severely impaired neurological control over the upper airway
  • Pregnancy
  • Surgery performed on the soft palate in the past three months before implantation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бельгия · 2 центра
  • Antwerp University Hospital — Edegem
  • AZ Sint-Jan Brugge — Bruges

Идентификаторы

NCT: NCT06332404 · B3002024000047

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗