NCT07001514

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?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

May 12, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

May 12, 2025

Last Update Submit

May 31, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • Sleep architecture REM

    Sleep architecture containing sleep stages REM - Random eye movement stage.

    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

    Sleep architecture containing sleep stages, Deep sleep

    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

    Sleep architecture containing sleep stages, light sleep

    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)

    time to fall asleep- through EEG headband

    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)

    Total amount or duration of sleep

    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 (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.

    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).

    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.

    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 (3)

  • 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

Other Outcomes (1)

  • Baseline survey

    Baseline (Day 0, at enrollment; one-time survey)

Study Arms (3)

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.

Behavioral: Calming digital content

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.

Behavioral: Exciting Digital Content

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.

Behavioral: Non-digital book reading

Interventions

Participants watch a curated selection of soothing documentaries narrated by Sir David Attenborough for 30-60 minutes each evening during one hour before bedtime.

Also known as: digital, nature documentary
Calming 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.

Also known as: Digital, Ruzzle, Game
Exciting Digital Content

Participants read a non-fiction book of their choice for the same duration, avoiding all digital screens during one hour before bedtime before bedtime.

Also known as: book reading
Non-Digital Pre-Sleep Activity

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blekinge Institute of Technology

Karlskrona, Blekinge County, SE-371 79, Sweden

Location

Study Officials

  • Peter Anderberg, PhD

    Blekinge Institute of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Anderberg, PhD

CONTACT

Sarah Nauman Ghazi, MD| M.Sc. | Fil. Licentiate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2025

First Posted

June 3, 2025

Study Start

August 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) will not be shared publicly because the study involves sensitive sleep and health-related data from older adult participants. To protect participant privacy and confidentiality, the data will remain anonymized and securely stored for analysis by the research team only. Public sharing of individual-level data is not planned.

Locations