Набор скоро начнётся NCT07001514

Evening Screen Content and Sleep Architecture in Older Adults: Crossover RCT

Без фазы С лечением 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: Calming digital content, Exciting Digital Content, Non-digital book reading.
Кому может быть актуально: Состояния в реестре: Sleep. Базовые параметры: 60 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: Швеция
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

The Effect of Evening Technology Use With Calming vs. Exciting Content on Sleep Architecture in Older Adults: A Crossover Randomized Controlled Trial

Обзор

Title The Effect of Evening Technology Use with Calming vs. Exciting Content on Sleep Architecture in Older Adults: A Crossover Randomized Controlled Trial Background The study explores how evening use of digital devices with different types of content (calming vs. exciting) affects sleep in older adults. While technology's effects on sleep have been studied in younger populations, its specific impacts on older adults remain under-researched. This study fills that gap by focusing on subjective and objective sleep measures. Objectives and Research Questions Objective: Compare the effects of calming digital content, exciting digital content, and non-digital activities on sleep architecture. Key Questions: How does content type impact sleep architecture and quality? Does calming content lead to better sleep outcomes than exciting content? Are there subjective differences in sleep quality across conditions?

Подробное описание

This study will compare the effects of watching calming (nature documentaries), playing exciting digital games like Ruzzle, and reading a physical book on older adults' subjective and objective sleep quality. This will be a randomized crossover trial. The investigators will exclude participants with diagnosed sleep disorders, Severe cognitive impairment, Use of sleep-affecting medications such as melatonin or benzodiazepines, or Irregular sleep schedules. A sample size of approximately 50 participants (49-51) will be recruited.

All the participants will have all three intervention periods with washout periods in between. During every intervention week, participants will fill out a quick nightly log about their sleep and what tech they used (smartphone, tablet, or a laptop/computer). During sleep, they will wear a comfy EEG headband measuring their sleep stages.

Because everyone eventually does all three conditions, the investigators can compare each person's own results and get more precise answers with fewer people.

The investigators will analyze the data and perform a statistical analysis. The study will be reported in the manuscript and published in a reputable journal.

Вмешательства

Поведенческое Calming digital content
Participants watch a curated selection of soothing documentaries narrated by Sir David Attenborough for 30-60 minutes each evening during one hour before bedtime.
Поведенческое Exciting Digital Content
Participants engage with the interactive word-based game Ruzzle for 30-60 minutes each evening during one hour before bedtime, designed to provide mental stimulation.
Поведенческое Non-digital book reading
Participants read a non-fiction book of their choice for the same duration, avoiding all digital screens during one hour before bedtime before bedtime.

Первичные конечные точки

Sleep architecture REM [Срок оценки: Nightly during each participant's 7-day intervention periods - Week 1 (Days 1-7), Week 3 (Days 15-21), and Week 5 (Days 29-35) after that participant's enrollment; up to 5 weeks per participant.]
Sleep architecture Deep Sleep [Срок оценки: Nightly during each participant's 7-day intervention periods - Week 1 (Days 1-7), Week 3 (Days 15-21), and Week 5 (Days 29-35) after that participant's enrollment; up to 5 weeks per participant.]
Sleep architecture, light sleep [Срок оценки: Nightly during each participant's 7-day intervention periods - Week 1 (Days 1-7), Week 3 (Days 15-21), and Week 5 (Days 29-35) after that participant's enrollment; up to 5 weeks per participant.]
Sleep latency (time to fall asleep) [Срок оценки: Nightly during each participant's 7-day intervention periods - Week 1 (Days 1-7), Week 3 (Days 15-21), and Week 5 (Days 29-35) after that participant's enrollment; up to 5 weeks per participant.]
Total sleep time (TST) [Срок оценки: Nightly during each participant's 7-day intervention periods - Week 1 (Days 1-7), Week 3 (Days 15-21), and Week 5 (Days 29-35) after that participant's enrollment; up to 5 weeks per participant.]
Sleep efficiency (SE) [Срок оценки: Nightly during each participant's 7-day intervention periods - Week 1 (Days 1-7), Week 3 (Days 15-21), and Week 5 (Days 29-35) after that participant's enrollment; up to 5 weeks per participant.]
Wake up after sleep onset (WASO). [Срок оценки: Nightly during each participant's 7-day intervention periods - Week 1 (Days 1-7), Week 3 (Days 15-21), and Week 5 (Days 29-35) after that participant's enrollment; up to 5 weeks per participant.]

Вторичные конечные точки (3)

Subjective sleep quality [Срок оценки: Each morning from Day 1 through Day 35 after each participant's enrollment, covering all intervention and washout weeks; up to 5 weeks per participant]
Comfort of using the EEG headband [Срок оценки: Each morning during each participant's 7-day intervention periods - Week 1 (Days 1-7), Week 3 (Days 15-21), and Week 5 (Days 29-35) after that participant's enrollment; up to 5 weeks per participant]
Intervention Adherence [Срок оценки: Each morning during each participant's 7-day intervention periods - Week 1 (Days 1-7), Week 3 (Days 15-21), and Week 5 (Days 29-35) after that participant's enrollment; up to 5 weeks per participant]

Критерии участия

Критерии включения

Age 60 - 75 years
Regular evening use of digital devices (e.g., smartphones or tablets)
Willing and able to wear an EEG headband for sleep monitoring throughout the intervention