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Набор по приглашению NCT07374393

Establishment of a Sleep and Sleep-disorder Research Cohort in Patients With Neurological Disorders

— Наблюдательное Sleep Neurology

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: Symptomatic and Etiological Treatment.
Кому может быть актуально
Состояния в реестре: Sleep, Neurology. Базовые параметры: 14 лет — 80 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
Китай
Следующий шаг
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Официальное название

Establishment of a Research Cohort on Sleep and Sleep Disorders in Patients With Neurological Diseases

Обзор

This study aims to establish a research cohort on sleep and sleep disorders in patients with neurological diseases to systematically evaluate the relationship between various neurological conditions and sleep characteristics or disturbances.

Подробное описание

The cohort will include patients with confirmed diagnoses such as stroke, Parkinson's disease, epilepsy, cognitive disorders, neuroinfections, and immune-mediated neurological diseases, with collection of demographic data, medical history, and lifestyle factors. All participants will undergo standardized polysomnography (PSG), sleep questionnaires, assessments of cognition, mood, daytime function, as well as relevant imaging and laboratory tests. Designed as a prospective observational study, the cohort will focus on sleep architecture alterations, periodic limb movements, sleep-disordered breathing, REM sleep behavior disorder, nocturnal awakenings, heart rate, and oxygen saturation, and their associations with disease severity and progression. The data will provide a basis for exploring the mechanisms, early indicators, and potential interventions for sleep disturbances in neurological patients.

Вмешательства

  • Другое Symptomatic and Etiological Treatment
    sleep-related

Первичные конечные точки

  • Total sleep time measured by polysomnography [Срок оценки: baseline, 3 months and one year]
  • Wake after sleep onset measured by polysomnography [Срок оценки: baseline, 3 months and one year]
  • Sleep onset latency measured by polysomnography [Срок оценки: baseline, 3 months and one year]
  • Number of arousal events measured by polysomnography [Срок оценки: baseline, 3 months and one year]
  • Rapid eye movement sleep onset latency measured by polysomnography [Срок оценки: baseline, 3 months and one year]
  • Non rapid eye movement sleep stage 1, 2, 3, and rapid eye movement sleep time measured by polysomnography [Срок оценки: baseline, 3 months and one year]
  • Number of awakenings related to the event measured by polysomnography [Срок оценки: baseline, 3 months and one year]
  • Number of respiratory events measured by polysomnography [Срок оценки: baseline, 3 months and one year]
  • Number of decreases in oxygen saturation measured by polysomnography [Срок оценки: baseline, 3 months and one year]
  • Sleep period heart rate measured by polysomnography [Срок оценки: baseline, 3 months and one year]
Вторичные конечные точки (4)
  • The score of Insomnia Severity Index scale [Срок оценки: baseline, 3 months and one year]
  • The score of 14-item Hamilton anxiety rating scale [Срок оценки: baseline, 3 months and one year]
  • The score of 17-item Hamilton depression rating scale [Срок оценки: baseline, 3 months and one year]
  • The score of montreal cognitive assessment scale [Срок оценки: baseline, 3 months and one year]

Критерии участия

Критерии включения

  • Confirmed diagnosis of neurological diseases, including but not limited to: Stroke (ischemic or hemorrhagic)，Parkinson's disease and other movement disorders，Epilepsy，Cognitive disorders (mild cognitive impairment or dementia)，Neuroinfections or immune-mediated neurological disorders
  • Ability to complete standardized polysomnography, sleep questionnaires, and assessments of cognition, mood, and daytime function
  • Voluntary participation and provision of written informed consent

Критерии исключения

  • Severe psychiatric disorders or unstable mental status precluding study assessments，Recent (within 3 months) serious infection, surgery, or major medical event
  • Previously diagnosed severe primary sleep disorders (e.g., sleep apnea) under active treatment， -Pregnancy or lactation (if the study involves medication or interventions)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • The first hospital of Jilin University — Changchun

Идентификаторы

NCT: NCT07374393 · SD-V01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗