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Идёт набор NCT06375447

Intelligent Diagnosis and Treatment Model for Insomnia Disorder

— Наблюдательное Insomnia

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: Routine clinical treatment.
Кому может быть актуально
Состояния в реестре: Insomnia. Базовые параметры: 18 лет — 75 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Study on an Intelligent Model for the Diagnosis and Treatment of Insomnia Disorder

Обзор

To establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder.

Подробное описание

The study endeavors to establish a multicenter cohort comprising 16,000 individuals diagnosed with insomnia disorder, with a subsequent 2-year follow-up. Objectives encompass elucidating the natural development of insomnia disorder within diverse populations, identifying associated factors, and evaluating the short-term and long-term impacts on physiological, psychological, and social functions in insomnia disorder. Additionally, the research aims to devise early screening methodologies, precise assessments, and innovative disease classifications utilizing real-time assessment technology within the insomnia disorder cohort. Furthermore, the investigation seeks to ascertain graded diagnoses, treatment modalities, and prognostic indicators based on advanced multi-dimensional real-time assessment technology applied to a substantial insomnia disorder cohort. Finally, the study aims to refine remote interactive diagnostic and treatment modalities tailored to diverse age groups, culminating in developing a systematic graded diagnostic and treatment framework for insomnia disorder.

Вмешательства

  • Другое Routine clinical treatment
    Routine clinical treatment is based on the latest international guidelines for insomnia.

Первичные конечные точки

  • The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
Вторичные конечные точки (12)
  • The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
  • The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
  • The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
  • The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
  • The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
  • The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
  • The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
  • The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
  • The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
  • The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
  • The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]
  • The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months]

Критерии участия

Критерии включения

  • A complaint of insomnia;
  • Age between 18 and 75;
  • Able to fill out the scale on their own;
  • Agree to sign the informed consent to participate in the study and cooperate in completing the follow-up visit.

Критерии исключения

1.A current or history of comorbid Axis I psychiatric disorders.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 5 центров
  • Xuanwu Hospital, Capital Medical University — Пекин
  • Beijing Tiantan Hospital, Capital Medical University — Пекин
  • The First Bethune Hospital of Jilin University — Changchun
  • West China Hospital, Sichuan University — Чэнду
  • The Second Affiliated Hospital of Soochow University — Сучжоу

Идентификаторы

NCT: NCT06375447 · Insomnia

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗