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临床试验/NCT07001514
NCT07001514尚未招募不适用

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

Blekinge Institute of Technology1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Sleep architecture REM

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •Diagnosed sleep disorder
  • •Severe cognitive impairment
  • •Current use of medications that significantly influence sleep (e.g., melatonin, benzodiazepines)

研究组 & 干预措施

Calming Digital Content

Experimental

Participants will watch calming digital content - specifically, nature documentaries narrated by Sir David Attenborough - for 30 to 60 minutes within one hour before bedtime. Sleep outcomes will be assessed using EEG recordings and subjective sleep quality logs.

干预措施: Calming digital content (Behavioral)

Exciting Digital Content

Experimental

Participants will engage with exciting digital content by playing the word-based game Ruzzle for 30 to 60 minutes within one hour before bedtime. Sleep outcomes will be evaluated using EEG measurements and subjective sleep assessments.

干预措施: Exciting Digital Content (Behavioral)

Non-Digital Pre-Sleep Activity

Active Comparator

Participants will engage in a non-digital activity by reading a physical, non-fiction book of their choice for 30 to 60 minutes within one hour before bedtime. No digital screens will be used. Sleep outcomes will be monitored via EEG data and self-reported sleep quality measures.

干预措施: Non-digital book reading (Behavioral)

结局指标

主要结局

Sleep architecture REM

时间窗: 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 containing sleep stages REM - Random eye movement stage.

Sleep architecture Deep Sleep

时间窗: 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 containing sleep stages, Deep sleep

Sleep architecture, light sleep

时间窗: 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 containing sleep stages, light sleep

Sleep latency (time to fall asleep)

时间窗: 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.

time to fall asleep- through EEG headband

Total sleep time (TST)

时间窗: 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 amount or duration of sleep

Sleep efficiency (SE)

时间窗: 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)- Sleep efficiency is the percentage of time in bed actually spent sleeping. It is calculated by dividing total sleep time by total time spent in bed and multiplying by 100. Higher sleep efficiency suggests less wakefulness during the night and better overall sleep quality.

Wake up after sleep onset (WASO).

时间窗: 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).WASO measures the cumulative amount of time a participant spends awake after initially falling asleep, until final morning awakening. Elevated WASO values may indicate fragmented or disrupted sleep, which can negatively affect sleep quality and daytime functioning.

次要结局

  • Subjective sleep quality(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(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(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)

研究者

发起方
Blekinge Institute of Technology
申办方类型
Other
责任方
Sponsor

研究点 (1)

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