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Идёт набор NCT05193136

Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease

Наблюдательное Sleep Hygiene Sarcopenia Cognitive Function COPD

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Sleep Hygiene, Sarcopenia, Cognitive Function, COPD. Базовые параметры: от 20 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
Япония
Следующий шаг
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Официальное название

Examination of the Relationship Between Sleep Hygiene, Sarcopenia, and Cognitive Function in Patients With Chronic Obstructive Pulmonary Disease or Idiopathic Pulmonary Fibrosis

Обзор

We aim to clarify the relationship between sleep hygiene and the onset of sarcopenia or cognitive dysfunction using sleep time, arousal, and sleep quality as indicators in COPD or IPF patients, and clarify the effects of sleep hygiene on disease progression and life prognosis.

Подробное описание

Chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) have been reported to be associated with a high rate of sleep-related disorders such as insomnia, sleep-related hypoventilation, and sleep apnea syndrome.Sleep-related disorders cause symptoms such as daytime sleepiness, decreased ADL, and depression, which causes cognitive dysfunction. Both COPD and IPF have been reported to be associated with cognitive dysfunction. Recently, it has been focused on the relationship between sleep-related disorders and sarcopenia. The relationship between sleep hygiene, cognitive dysfunction, and sarcopenia in the patients with COPD or IPF is not well understood.

Первичные конечные точки

  • Relationship between sleep time at study enrollment and onset of sarcopenia during follow-up period [Срок оценки: Two years]
Вторичные конечные точки (6)
  • Relationship between sleep time at study enrollment and the onset of mild cognitive impairment during follow-up period [Срок оценки: Two years]
  • Relationship between sleep efficiency, arousal at the time of study enrollment and the onset of sarcopenia and mild cognitive impairment during the follow-up period [Срок оценки: Two years]
  • Association of sleep time, sleep efficiency, arousal at the time of study enrollment and hospitalization and death due to COPD exacerbations or IPF exacerbations during follow-up period [Срок оценки: Two years]
  • Relationship between sleep time, sleep efficiency, arousal at the time of study enrollment and changes in grip strength, walking speed, skeletal muscle mass and cognitive function during follow-up period [Срок оценки: Two years]
  • Relationship between sleep time, sleep efficiency, arousal at the time of study enrollment and changes in grip strength, walking speed, skeletal muscle mass and cognitive function at the time of study enrollment [Срок оценки: Two years]
  • Factors associated with the onset of sarcopenia and mild cognitive impairment during follow-up period [Срок оценки: Two years]

Критерии участия

Критерии включения

  • Subjects with COPD or IPF.

Критерии исключения

  • Subjects who have been hospitalized for exacerbation of respiratory failure within 1 month of study participation
  • Subjects who have already been diagnosed with sarcopenia or cognitive dysfunction
  • Subjects receiving long-term oxygen therapy (LTOT) or non-invasive ventilation therapy (NIV)
  • Subjects with obstructive sleep apnea who are indicated for continuous positive airway pressure (CPAP)
  • Subjects with severe complications such as cardiovascular disease, liver disease, renal disease, malignancy, and neurological disease.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Япония · 1 центр
  • National Hospital Organization Minami Kyoto Hospital — Jōyō

Идентификаторы

NCT: NCT05193136 · 2020-32

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗