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Набор скоро начнётся NCT07731516

Personalised Sleep and Circadian Intervention After Stroke

Без фазы С лечением Stroke Sleep

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: ISleepFAST, Stroke and Sleep Health Education.
Кому может быть актуально
Состояния в реестре: Stroke, Sleep. Базовые параметры: от 18 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
Гонконг
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

Feasibility, Efficacy, and Patient Experience of a Personalised Transdiagnostic Intervention for Sleep and Circadian Dysfunction Following Stroke: a Mixed-method Randomised Controlled Feasibility Trial

Обзор

This is a two-arm, parallel-group randomized controlled feasibility trial involving 40 community-dwelling adults with chronic stroke and ongoing sleep or circadian difficulties. Participants will be randomly assigned in a 1:1 ratio to either an individualized behavioral sleep intervention or an attention-matched health education program. Before randomization, participants will complete questionnaires assessing sleep and related health outcomes, maintain a sleep diary, and wear a wrist-worn activity monitor for seven days. Participants will then attend six weekly, individual, face-to-face sessions lasting approximately one hour each. The behavioral sleep intervention will provide individualized education and behavioral strategies to support sleep and daily sleep-wake functioning following stroke. The comparison program will provide education about stroke, sleep, and general health. The two programs will be matched in session frequency and duration. Following the six-week program, participants will repeat the questionnaires, sleep diary, and seven-day wrist-monitoring assessment. Participants will also provide feedback about their experiences with the study and program. The trial will evaluate recruitment, retention, attendance, intervention delivery, acceptability, fidelity, and safety. Preliminary changes in sleep and sleep-wake outcomes will also be examined.

Вмешательства

  • Поведенческое ISleepFAST
    A six-week, individual, face-to-face behavioral program designed to address sleep and sleep-wake difficulties following stroke. Participants attend one approximately 60-minute session per week. The program provides education and individualized behavioral strategies based on each participant's sleep-related needs.
  • Поведенческое Stroke and Sleep Health Education
    A six-week education program providing general information about stroke, sleep, and health.

Первичные конечные точки

  • Recruitment Rate [Срок оценки: From the start of recruitment through completion of recruitment]
  • Participant Retention [Срок оценки: From enrollment through completion of the 3-month follow-up.]
  • Intervention Attendance [Срок оценки: Up to 6 weeks.]
  • Acceptability [Срок оценки: Immediately after the 6-week intervention.]
  • Number of Adverse Events [Срок оценки: From enrollment through the 3-month follow-up, up to approximately 5 months.]
  • Fidelity [Срок оценки: Throughout the 6-week intervention period.]
Вторичные конечные точки (2)
  • Change in Sleep and Circadian Sleep-Wake Functioning [Срок оценки: Baseline, immediately after the intervention, 3-month follow-up]
  • Change in Sleep Disturbance [Срок оценки: Baseline, immediately after the 6-week intervention, and 3 months after the intervention.]

Критерии участия

Критерии включения

  • >6 months from last stroke
  • aged ≥18 years
  • Cantonese language fluency
  • ≥1 self-reported sleep or circadian problem(s) for 3 months: ≥30 min to get to sleep on ≥3 nights per week, waking in the middle of night ≥30 min on ≥3 nights per week, <6-hr sleep per night or ≥9-hr sleep per 24 hour period on ≥3 nights per week, ≥1.09 hours of variability in sleep-wake schedule across one week, and/or bedtime after 2:00 a.m. on ≥3 nights per week
  • adequate opportunities for sleep.

Критерии исключения

  • presence of an active and progressive physical or neurocognitive illness or substance abuse making participation infeasible
  • past or current involvement in psychological treatment for sleep issues
  • night shift work
  • pregnancy or breastfeeding.

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

Гонконг · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT07731516 · HSEARS20250925007 · 23240951

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗