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Идёт набор NCT06969066

Memory Training in Insomnia With Cognitive Impairment

Без фазы С лечением Cognitive Therapy/Methods Insomnia Chronic Cognitive Dysfunction

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: Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE), Sleep Hygiene Education Only (SHE).
Кому может быть актуально
Состояния в реестре: Cognitive Therapy/Methods, Insomnia Chronic, Cognitive Dysfunction. Базовые параметры: от 8 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 →
Официальное название

Effect of Cognitive Remediation Therapy (CRT) for Chronic Insomnia (CI) With Cognitive Impairment

Обзор

This randomized controlled trial investigates the effects of Cognitive Remediation Therapy (CRT) on chronic insomnia (CI) with mild cognitive impairment.

Подробное описание

Chronic insomnia (CI) is a prevalent sleep disorder that not only causes night-time sleep difficulties but also impairs daytime functioning and cognitive abilities, including deficits in attention, memory, and executive function. Persistent insomnia may diminish the brain's information processing capacity, affecting memory, attention, and decision-making. CRT, a structured cognitive training intervention, has been shown in psychiatric populations to enhance memory, attention, and executive function by promoting neuroplasticity, neurotransmitter modulation, and optimizing brain activity patterns.

Applying CRT to CI patients may similarly support cognitive recovery and indirectly improve sleep quality. However, empirical evidence remains limited.

This randomized controlled trial will enroll 70 patients with CI and cognitive decline. Participants will be randomly assigned to either a CRT plus Sleep Hygiene Education (SHE) group or an SHE-only group (n=35 each). The CRT intervention will last 6 weeks, with daily 50-minute sessions. Evaluations will occur at baseline, post-intervention, and at 3, 6, and 12 months follow-up. This study aims to provide evidence for CRT as a treatment for CI with cognitive impairment and inform future clinical practices.

Вмешательства

  • Поведенческое Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE)
    Participants will receive Cognitive Remediation Therapy (CRT) combined with Sleep Hygiene Education (SHE). CRT includes structured training sessions targeting attention, memory, visuospatial skills, calculation ability, logical reasoning, and language abilities. Sessions will be conducted daily for 50 minutes over 6 weeks. Sleep Hygiene Education will cover standard recommendations to improve sleep behaviors.
  • Поведенческое Sleep Hygiene Education Only (SHE)
    Participants will receive Sleep Hygiene Education (SHE) only, including guidance on adjusting sleep schedules, maintaining healthy sleep environments, minimizing stimulant intake, and managing sleep-related behaviors, without any CRT intervention.

Первичные конечные точки

  • The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks. [Срок оценки: Baseline, 6 weeks]
Вторичные конечные точки (12)
  • The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 3 months, 6 months, 12 months]
  • The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months.]
  • The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
  • The change of Life Events Scale (LES) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]

Критерии участия

Критерии включения

  • Meets the diagnostic criteria for Insomnia Disorder according to DSM-5.
  • Pittsburgh Sleep Quality Index (PSQI) total score > 5.
  • Age ≥ 8 years.
  • Voluntary participation with signed informed consent.
  • Meets the cognitive impairment criteria associated with CI:

(1) Right-handedness. (2) Age between 55 and 75 years. (3) Education duration ≥ 12 years. (4) At least junior high school education level; fulfills Petersen's diagnostic criteria for mild cognitive impairment: 1.Subjective complaints of memory decline. 2.Duration of cognitive complaints ≥ 3 months. 3.Assessment scores: Global Deterioration Scale (GDS) rating of stage 1-2; Clinical Dementia Rating (CDR) score of 0-0.5. 4.Memory test scores falling ≥ 1.5 standard deviations below the age- and education-matched norms: MMSE ≥ 24, MoCA < 26, Activities of Daily Living (ADL) score > 26. 5.Memory impairment as the primary deficit, with relatively preserved functioning in other cognitive domains.

6.Normal daily functional abilities. 7.Exclusion of dementia or any major physical or psychiatric disorders that could impair brain function.

Критерии исключения

  • Presence of severe physical illnesses or major psychiatric disorders, or assessed risk of suicide.
  • Diagnosed or suspected sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or currently engaged in shift work.
  • Pregnancy or breastfeeding.
  • Currently undergoing any form of psychological therapy.
  • History of infectious diseases such as syphilis or HIV.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Xuanwu Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT06969066 · CI-CRT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗