Идёт набор NCT06658184
Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients
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: sleep restriction and stimulus control, sleep hygiene education.
- Кому может быть актуально
- Состояния в реестре: Chronic Insomnia. Базовые параметры: 18 лет — 65 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients With Prolonged Bed Rest and Maladaptive Sleep Patterns
Обзор
The study aims to validate the effect of sleep restriction and stimulus control on improving chronic insomnia patients\' sleep habits and maladaptive sleep behaviors.
Подробное описание
The purpose of sleep restriction is to reduce the patient\'s time in bed, bringing it closer to their actual sleep time, thereby improving sleep efficiency and quality. Stimulus control, on the other hand, aims to associate the bed with a rapid sense of falling asleep, reducing the negative association between the bed and insomnia.
Вмешательства
- Поведенческое sleep restriction and stimulus control
Sleep restriction: a) Reduce bedtime to match actual sleep time, but ≥4.5 hours, and adjust bedtime according to sleep efficiency; b) Avoid daytime naps and maintain a regular wake-up time. Stimulus control: a) Reduce wakeful time in bed and rebuild a positive association between sleepiness and bed; b) Use the bed solely for sleeping and sexual activities; c) Only go to bed when feeling sleepy at night or at the designated sleep time; d) If unable to fall asleep within about 20 minutes of being - Поведенческое sleep hygiene education
Sleep hygiene education: 1. Sleep until feeling refreshed the next day. 2. Maintain regular exercise and eating habits, avoiding going to bed on an empty stomach. 3. Ensure a comfortable bedroom environment with suitable nighttime temperature, free from light and noise disturbances. 4. Avoid excessive consumption of beverages, alcohol, and smoking at night, and reduce caffeine intake. 5. Avoid bringing problems to bed and refrain from attempting to sleep. 6. Place the alarm clock under the bed
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, and 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 3 months, 6 months, 12 months, 18 months, and 24 months [Срок оценки: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months]
Критерии участия
Критерии включения
- Meet the diagnostic criteria for insomnia disorder as per DSM-5.
- Pittsburgh Sleep Quality Index (PSQI) total score > 5.
- Age ≥ 18 years, at least a junior high school education level.
- Assessment of sleep-wake behavior by sleep diary.
- Assessment of "maladaptive sleep behavior" by self-designed 8-item questionnaire.
- Voluntary participation in the study and signing an informed consent form.
Критерии исключения
- Presence of severe physical or severe mental illness, and suicide risk.
- Clinical diagnosis or suspicion of sleep-breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as individuals working in rotating shifts or with shift work.
- Pregnant or lactating women.
- Currently undergoing any form of psychological therapy.
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Xuanwu Hospital, Capital Medical University — Пекин
Идентификаторы
NCT: NCT06658184 · SR-SC-insomnia