Clinical trial NCT07001514: Evening Screen Content and Sleep Architecture in Older Adults: Crossover RCT
Official title: The Effect of Evening Technology Use With Calming vs. Exciting Content on Sleep Architecture in Older Adults: A Crossover Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep
Lead sponsor: Blekinge Institute of Technology
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: 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?

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria:

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

Primary outcomes:
measure: Sleep architecture REM
timeFrame: 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.
measure: Sleep architecture Deep Sleep
timeFrame: 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.
measure: Sleep architecture, light sleep
timeFrame: 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.
measure: Sleep latency (time to fall asleep)
timeFrame: 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.
measure: Total sleep time (TST)
timeFrame: 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.
measure: Sleep efficiency (SE)
timeFrame: 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.
measure: Wake up after sleep onset (WASO).
timeFrame: 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.
Secondary outcomes:
measure: Subjective sleep quality
timeFrame: 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
measure: Comfort of using the EEG headband
timeFrame: 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
measure: Intervention Adherence
timeFrame: 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
Other outcomes:
measure: Baseline survey
timeFrame: Baseline (Day 0, at enrollment; one-time survey)
Locations:
city: Karlskrona
country: Sweden
facility: Blekinge Institute of Technology
state: Blekinge
Study officials:
affiliation: Blekinge Institute of Technology
name: Peter Anderberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: