ANZCTR - Registration

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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

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]

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

Condition category

Condition code

Public Health

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]

Not applicable

Comparator / control treatment

Not applicable as this is an observational study.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Sleep duration measured by actigraphy

Timepoint [1]

Nights 1, 2, 4 and 6 of study week

Primary outcome [2]

Sleep efficiency by actigraphy

Timepoint [2]

NIghts 1, 2, 4 and 6 of study week

Secondary outcome [1]

Dietary intake (24-hour recall)

Timepoint [1]

Days 3, 5, and 7 of study week

Secondary outcome [2]

WHO-5 wellbeing index

Timepoint [2]

Days 2, 3, 4, 5, 6, 7 and 8 of study week

Secondary outcome [3]

Kidscreen-10 and WHO-5 (quality of life)

Timepoint [3]

Days 2, 3, 4, 5, 6, 7 and 8 of study week

Secondary outcome [4]

General mood (single question assessing how they feel today with 5 answer options ranging from 'very bad' to 'very good')

Timepoint [4]

Days 2, 3, 4, 5, 6, 7 and 8 of study week

Secondary outcome [5]

PROMIS sleep impairment

Timepoint [5]

Days 2, 3, 4, 5, 6, 7 and 8 of study week

Secondary outcome [6]

Sleep by AX3 actigraphy

Timepoint [6]

Days 2, 3, 5 and 7 of study week

Secondary outcome [7]

Physical activity by AX3 actigraphy

Timepoint [7]

Days 2, 3, 5 and 7 of study week

Secondary outcome [8]

Sedentary time by AX3 actigraphy

Timepoint [8]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Otago Medical Research Foundation

Address [1]

P.O. Box 5726
Dunedin 9054
New Zealand

Country [1]

New Zealand

Funding source category [2]

University

Name [2]

University of Otago Research Grant (UORG)

Address [2]

362 Leith Street
North Dunedin
Dunedin 9016

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Ethics Committee (Health)

Ethics committee address [1]

362 Leith Street
North Dunedin
Dunedin 9016

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

08/06/2020

Approval date [1]

22/06/2020

Ethics approval number [1]

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

Prof Rachael Taylor

Address

Department of Medicine
University of Otago
PO Box 56
Dunedin 9010

Country

New Zealand

Phone

+64 21479556

Fax

rachael.taylor@otago.ac.nz

Contact person for public queries

Name

Rachael Taylor

Address

Department of Medicine
University of Otago
PO Box 56
Dunedin 9010

Country

New Zealand

Phone

+64 21479556

Fax

rachael.taylor@otago.ac.nz

Contact person for scientific queries

Name

Rachael Taylor

Address

Department of Medicine
University of Otago
PO Box 56
Dunedin 9010

Country

New Zealand

Phone

+64 21479556

Fax

rachael.taylor@otago.ac.nz

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 rachael.taylor@otago.ac.nz.

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

Source	Title	Year of Publication	DOI
Embase	Development of a Protocol for Objectively Measuring Digital Device Use in Youth.	2023	https://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.

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Documents added manually

Documents added automatically