Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000193875
Ethics application status
Approved
Date submitted
30/11/2020
Date registered
23/02/2021
Date last updated
22/02/2022
Date data sharing statement initially provided
23/02/2021
Date results information initially provided
22/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Streaming before dreaming: How do electronic devices influence sleep in children?
Scientific title
How do electronic devices influence sleep in children? The Bedtime Electronic Devices (BED) study.
Secondary ID [1] 302780 0
None
Universal Trial Number (UTN)
Not applicable
Trial acronym
BED
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Sleep 319722 0
Condition category
Condition code
Public Health 317655 317655 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Over the course of one week, children will wear an AX3 accelerometer which will determine sleep, physical activity, and sedentary behaviour each day. Information will be supplemented from that obtained by 24-hour heart rate monitoring. Each day they will complete brief questionnaires examining screen use and sleep the previous night, and mood and wellbeing that day. On four nights during this week (days 1, 2, 4, and 6), cameras will collect objective data on screen use both before bed, and while in bed. On three days (days 3, 5 and 7), dietary intake will be determined using 24-hour recalls. All measurements will be undertaken in the home environment.
Intervention code [1] 319055 0
Not applicable
Comparator / control treatment
Not applicable as this is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325706 0
Sleep duration measured by actigraphy
Timepoint [1] 325706 0
Nights 1, 2, 4 and 6 of study week
Primary outcome [2] 325707 0
Sleep efficiency by actigraphy
Timepoint [2] 325707 0
NIghts 1, 2, 4 and 6 of study week
Secondary outcome [1] 388820 0
Dietary intake (24-hour recall)
Timepoint [1] 388820 0
Days 3, 5, and 7 of study week
Secondary outcome [2] 388821 0
WHO-5 wellbeing index
Timepoint [2] 388821 0
Days 2, 3, 4, 5, 6, 7 and 8 of study week
Secondary outcome [3] 388822 0
Kidscreen-10 and WHO-5 (quality of life)
Timepoint [3] 388822 0
Days 2, 3, 4, 5, 6, 7 and 8 of study week
Secondary outcome [4] 388823 0
General mood (single question assessing how they feel today with 5 answer options ranging from 'very bad' to 'very good')
Timepoint [4] 388823 0
Days 2, 3, 4, 5, 6, 7 and 8 of study week
Secondary outcome [5] 388824 0
PROMIS sleep impairment
Timepoint [5] 388824 0
Days 2, 3, 4, 5, 6, 7 and 8 of study week
Secondary outcome [6] 389229 0
Sleep by AX3 actigraphy
Timepoint [6] 389229 0
Days 2, 3, 5 and 7 of study week
Secondary outcome [7] 391003 0
Physical activity by AX3 actigraphy
Timepoint [7] 391003 0
Days 2, 3, 5 and 7 of study week
Secondary outcome [8] 391004 0
Sedentary time by AX3 actigraphy
Timepoint [8] 391004 0
Days 2, 3, 5 and 7 of study week

Eligibility
Key inclusion criteria
Children aged 11.0 to < 15 years.
Living in Dunedin city and surrounding areas.
Minimum age
11 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those with developmental disabilities and/or congenital abnormalities that would make it difficult to comply with the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
A sample size of 66 participants is required to estimate the relationship between pre-bedtime screen behaviours and sleep duration/quality, assuming four predictors in the model. This uses a relatively high ICC of 0.7 and at least 3 nights of sleep. The sample size will be increased to 85 to allow for drop-out and non-completion of data.

The association between pre-bedtime screen behaviours and sleep duration or quality will be estimated using mixed effects regression models, with the sleep variable as the dependent variable, and pre-bedtime behaviours as predictors. Participant will be included as a random effect. To assess the relationship of sleep and pre-bedtime behaviours with dietary intakes or physical activity the next day, the same type of model will be used but with diet (or activity) as the outcome. Mediation analysis will estimate the pathway from pre-bedtime behaviours through sleep to dietary intake.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/03/2021
Actual
19/03/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
9/12/2021
Date of last data collection
Anticipated
8/07/2022
Actual
16/12/2021
Sample size
Target
85
Accrual to date
Final
85
Recruitment outside Australia
Country [1] 23099 0
New Zealand
State/province [1] 23099 0
Otago

Funding & Sponsors
Funding source category [1] 307196 0
Charities/Societies/Foundations
Name [1] 307196 0
Otago Medical Research Foundation
Country [1] 307196 0
New Zealand
Funding source category [2] 307197 0
University
Name [2] 307197 0
University of Otago Research Grant (UORG)
Country [2] 307197 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street
North Dunedin
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 307804 0
None
Name [1] 307804 0
Address [1] 307804 0
Country [1] 307804 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307305 0
University of Otago Ethics Committee (Health)
Ethics committee address [1] 307305 0
362 Leith Street
North Dunedin
Dunedin 9016
Ethics committee country [1] 307305 0
New Zealand
Date submitted for ethics approval [1] 307305 0
08/06/2020
Approval date [1] 307305 0
22/06/2020
Ethics approval number [1] 307305 0
H20/065

Summary
Brief summary
Using electronic media before bed leads to poor sleep, which in turn, impacts how well children function the following day. We don’t currently know how much children are using electronic media in the evening (including after “lights out”), whether more interactive behaviours like gaming are worse than reading a book on your iPad, or whether using multiple devices at the same time have different effects on sleep in 11-14 year old children. We will measure evening screen behaviours both subjectively (usual questionnaire and brief daily recall) and objectively (wearable cameras from 3 hours before bedtime until bedtime, and stationary cameras overnight in the child's bedroom) on several nights over the course of one week in children aged 11.0-14.9 years. Children will wear an AX3 actrigraph and Fitbit Inspire 2 (heart rate monitoring) 24-hours a day for 8 days and nights to measure 24-hour activity composition (daily sleep, physical activity and sedentary behaviour). Dietary intake will be assessed on three days using 24-hour recalls, supplemented with camera images of food eaten (act as prompts for children). Sleep impairment, mood, and wellbeing will be measured each day by brief online questionnaire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106762 0
Prof Rachael Taylor
Address 106762 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9010
Country 106762 0
New Zealand
Phone 106762 0
+64 21479556
Fax 106762 0
Email 106762 0
[email protected]
Contact person for public queries
Name 106763 0
Prof Rachael Taylor
Address 106763 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9010
Country 106763 0
New Zealand
Phone 106763 0
+64 21479556
Fax 106763 0
Email 106763 0
[email protected]
Contact person for scientific queries
Name 106764 0
Prof Rachael Taylor
Address 106764 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9010
Country 106764 0
New Zealand
Phone 106764 0
+64 21479556
Fax 106764 0
Email 106764 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Sleep, physical activity, sedentary behaviour from actigraphy.
Dietary intake from 24-hour recalls.
Coded outputs from camera data (no original camera images).
Demographics and questionnaire data.
When will data be available (start and end dates)?
We anticipate that relevant data will be available from Jan 2024 to Dec 2024.
Available to whom?
Data will be available to all on reasonable request.
Available for what types of analyses?
Please contact the principal investigator to discuss proposed analyses.
How or where can data be obtained?
Please contact the principal investigator at [email protected].


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDevelopment of a Protocol for Objectively Measuring Digital Device Use in Youth.2023https://dx.doi.org/10.1016/j.amepre.2023.05.004
N.B. These documents automatically identified may not have been verified by the study sponsor.