Development and Online Evaluation of an Online Course for Parasomnias
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: Parasomnia Education, Sleep Hygiene Control.
- Кому может быть актуально
- Состояния в реестре: Sleep Terror, Sleepwalking, Nightmare Disorder, REM Sleep Behavior Disorder (iRBD). 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
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Parasomnias are unwanted events during sleep. These refer to sleep terrors, sleepwalking, sleep eating, nightmares, and movement during REM sleep. There are few systematic behavioral treatments for these problems and individuals with them often receive little education about self-management. This research examines and evaluates the effectiveness of a 4 week online course providing education and guidance about managing parasomnias. The primary outcomes are improvement in parasomnia frequency and distress. The secondary outcomes are improvements in work and social adjustment, mood, anxiety, stress level, fatigue, sleepiness, insomnia, and cognitive interference.
Подробное описание
Parasomnia disorders are prevalent and impactful conditions, however, there are challenges with disseminating evidence-based interventions for these problems. The rationale for this project is to deliver an online evidence-based course for parasomnias to adults with these disorders to provide education and help for these conditions. The objectives are to determine whether participation in the course reduces the frequency and severity of parasomnias, as evaluated using a sleep diary. Study hypotheses are as follows: a) those receiving the course compared to sleep hygiene education will have a reduction in frequency and severity of parasomnias; b) those receiving the online course compared to sleep hygiene education will have a reduction in sleepiness, fatigue, insomnia, perceived cognitive interference, depression, anxiety, stress, and work and social life interference.
This is a single-blind, randomized controlled trial with two conditions (online course, sleep hygiene education). Participants will be 20 adult outpatients referred to the Behavioral Sleep Medicine Clinic at the Health Sciences Center for treatment of a parasomnia.
Participants will be recruited off the waiting list of an outpatient Behavioral Sleep Medicine Clinic. A research coordinator will screen eligible participants over the telephone and obtain informed consent. Following this, participants will be given a study ID# and link to a pre-treatment survey. Once survey materials have been submitted, participants will be randomized to the online course or to weekly sleep hygiene newsletter, through an automated randomization service. Both groups will monitor their sleep throughout the study using a sleep diary (daily), and complete several questionnaires (weekly). The online course will consist of 4 weekly virtual logins and review of material. The control group will consist of receipt of weekly sleep hygiene tips communicated through a newsletter. At the end of 4 weeks, and at a 2 month follow-up, the surveys will be re-administered.
Вмешательства
- Поведенческое Parasomnia Education
Week 1: education about types of parasomnias and their causes Week 2: safety planning, relaxation training and imagery rehearsal therapy Week 3: Lucid dreaming, imagery rehearsal therapy, scheduled awakenings Week 4: cognitive therapy, review - Поведенческое Sleep Hygiene Control
Week 1: safety planning Week 2: caffeine, cannabis, alcohol, nicotine Week 3: exercising, napping, eating before bed Week 4: noise, light, temperature
Первичные конечные точки
- self-reported parasomnia severity [Срок оценки: baseline, week 4, week 6]
- self-reported parasomnia frequency [Срок оценки: baseline, week 4, week 6]
Вторичные конечные точки (10)
- Secondary measures [Срок оценки: baseline, week 4, week 6]
- Sleepiness [Срок оценки: baseline, week 4, week 6]
- Insomnia Severity [Срок оценки: baseline, week 4, week 6]
- NREM parasomnia symptoms [Срок оценки: baseline, week 4, week 6]
- REM parasomnia symptoms [Срок оценки: baseline, week 4, week 6]
- nightmare frequency and severity [Срок оценки: baseline, week 4, week 6]
- Daytime consequences of parasomnias [Срок оценки: baseline, week 4, week 6]
- Work and Social Interference [Срок оценки: baseline, week 4, week 6]
- Perceived Cognition [Срок оценки: baseline, week 4, week 6]
- Mental Health Symptoms [Срок оценки: baseline, week 4, week 6]
Критерии участия
Критерии включения
- physician referred for parasomnia
- meet criteria for parasomnia on the Structured Clinical Interview for Sleep Disorders (SCISD-R)
- age >= 18 years
- parasomnia duration >= 6 months
- English reading, sighted
- access to device.
Критерии исключения
- currently taking one of Lithium, Thioridazine, Chlorpromazine, Perphenazine, Methaqualone, Amitriptyline, Selective Serotonin Re-Uptake Inhibitors, Serotonin and Norepinephrine Re-Uptake inhibitors, or Zopiclone
- seizure or major neurological disorder
- untreated sleep apnea, restless legs syndrome, or narcolepsy
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
Канада · 1 центр
- Psychealth Center, University of Manitoba — Winnipeg
Идентификаторы
NCT: NCT07361315 · HS26738