Идёт набор NCT06559956

Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy

— 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: Daytime titration polysomnography.
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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea

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. Approximately 3 months after activation of HNS therapy, a fine-tuning sleep study is performed. To date, the standard of care involves an in-laboratory overnight titration PSG, which assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Considering the growing patient population, the performance of these overnight titrations can become logistically challenging and labor-intensive. Recently, the feasibility of using a daytime PSG as an alternative to a conventional overnight PSG for titration of HNS therapy was demonstrated. The aim of this study is to further investigate this technique by performing a non-inferiority analysis of daytime versus overnight PSG for titration of HNS therapy in patients with OSA.

Подробное описание

This study is a prospective and retrospective, single-center non-inferiority study. The study population consists of two cohorts: (1) OSA patients treated with HNS that previously underwent an overnight titration PSG as part of the routine clinical care pathway and (2) OSA patients treated with HNS that recently underwent or will be undergoing a daytime titration PSG.

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 different visits including: pre-implant, implant, activation, titration, follow-up (6 and 12 months post-implantation).

Вмешательства

Другое Daytime titration polysomnography
A titration polysomnography assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Patients in the daytime titration PSG cohort were instructed to refrain from sleeping during the night, and in the morning, they were permitted to sleep in a soundproof room without daylight at the sleep lab.

Первичные конечные точки

Non-inferiority of the delta apnea-hypopnea index (AHI) between the two cohorts as measured by a titration polysomnography [Срок оценки: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)]

Вторичные конечные точки (11)

Percent 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 the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
Treatment AHI as measured during a titration polysomnography [Срок оценки: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)]
Full-night AHI as measured during a titration polysomnography [Срок оценки: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)]
Percent of time spent in each sleep stage as measured during a titration polysomnography [Срок оценки: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)]
Percent of time spent in different body positions during a titration polysomnography [Срок оценки: At the postoperative titration follow-up (approximately 3 months after activation of the therapy)]
Delta oxygen desaturation index (ODI) as measured by a polysomnography [Срок оценки: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire [Срок оценки: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire [Срок оценки: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire [Срок оценки: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
Therapy adherence defined by the amount of hours therapy usage per night [Срок оценки: At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up]
Delta sleep apnea specific hypoxic burden (SASHB) derived from a titration polysomnography [Срок оценки: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)]

Критерии участия

Критерии включения

Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)
Cohort 1: Patients that previously underwent an overnight titration PSG as part of their routine clinical care at the Antwerp University Hospital
Cohort 2: Patients that recently underwent or will be undergoing a daytime titration PSG at the Antwerp University Hospital
Able to give informed consent