Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00627

2 Trial Registration Date

2018-10-11

i Registration Status

Prospective

3 Secondary IDs

CREC Ref.NO.: 2018.222-T

4 Source(s) of Funding

Departmental funding

5 Primary Sponsor

Department of Paediatrics, CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Chun-Ting Au

ii Address

Department of Paediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T., Hong Kong SAR, China

iii Phone

35052917

iv Email

junau@cuhk.edu.hk

v Affiliation

Department of Paediatrics

vi Country

Hong Kong SAR, China

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Albert Marin Li

ii Address

Department of Paediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T., Hong Kong SAR, China

iii Phone

26322982

iv Email

albertmli@cuhk.edu.hk

v Affiliation

Department of Paediatrics

vi Country

Hong Kong SAR, China

9 Official Scientific Title of the Study

Randomised controlled study to examine the efficacy of sleep education on extending sleep duration of pre-school children

10 Public Title

Randomised controlled study to examine the efficacy of sleep education on extending sleep duration of pre-school children

i Public Title in Chinese 研究名稱

教育家長對改善學前兒童睡眠的成效 - 隨機對照研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-05-15

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC Ref.NO.: 2018.222-T

14 Medical Condition Being Studied

Short sleep duration

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

The main caregiver(s) of the subjects will have to attend three educational workshop sessions delivered by the principal investigator over consecutive weeks (week 1-3). General principles on functions and importance of sleep, factors that influence preschooler children’s sleep and ways to help extend sleep duration will be discussed. Each workshop presentation will last for around 40 minutes and then time will be allocated for group discussion and design of individual management strategy for each family. For each workshop session, we will limit the number of families to a maximum of 10 to allow for more in-depth discussion between family members and the investigator. Weekly (week 1-7) telephone interview will be conducted by research personnel to answer queries, provide support and reinforce strategies decided for that particular family, followed by a 6-week (week 8-13) maintenance period.

iii Dosage form of the intervention

Workshop and telephone interview

iv Dosage of the intervention

3 workshops over consecutive weeks (week 1-3), and 7 telephone interviews (week 1-7)

v Duration of the intervention

7 weeks

vi Frequency of the intervention

Weekly

16 Comparative Treatments

i Description/ name of comparative treatments

Continue with their usual bedtime schedules

ii Dosage form of the comparative treatments

Telephone interview

iii Dosage of the comparative treatments

7

iv Duration of the comparative treatments

7 weeks

v Frequency of the comparative treatments

Weekly

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Preschool children aged between 3 and 5 years old.

2. Parent-reported weekday sleep duration <25th percentile of each age within each kindergarten.

3. Parents’ willingness to follow study protocol to extend their child’s sleep

ii Exclusion Criteria

1. Presence of habitual snoring

2. Acute physical illness within 4 weeks of recruitment

3. Chronic illness that may affect the child’s sleep pattern for example poorly controlled asthma and or eczema

4. Use of any medication or diagnosed to have developmental or psychiatric disorder.

iii Age Minimum

3

iv Age Maximum

5

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomised controlled study

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

2

Please specify

vi Study Objectives (Optional)

Prolong children sleep duration

20 Anticipated trial start date

2018-11-01

21 Target Sample Size

200

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Sleep duration

ii The metric or method of measurement used

Actigraphy and sleep diary

iii The timepoint(s) of primary interest

Week 0, Week 7, Week 13

24 Secondary Outcome

i The Name of the outcome

Sleep efficiency,

ii The metric or method of measurement used

Actigraphy

iii The timepoint(s) of primary interest

Week 0, Week 7, Week 13

Secondary Outcome

i The Name of the outcome

Wake after sleep onset (WASO)

ii The metric or method of measurement used

Actigraphy

iii The timepoint(s) of primary interest

Week 0, Week 7, Week 13

Secondary Outcome

i The Name of the outcome

Sleep latency

ii The metric or method of measurement used

Actigraphy

iii The timepoint(s) of primary interest

Week 0, Week 7, Week 13

Secondary Outcome

i The Name of the outcome

Behavioural problem score

ii The metric or method of measurement used

Child Behaviour Checklist (CBCL)

iii The timepoint(s) of primary interest

Week 0, Week 7, Week 13

Secondary Outcome

i The Name of the outcome

Sleep problem score

ii The metric or method of measurement used

Children Sleep Habit Questionnaire (CSHQ)

iii The timepoint(s) of primary interest

Week 0, Week 7, Week 13

Secondary Outcome

i The Name of the outcome

Objective measures of attention

ii The metric or method of measurement used

Conners Kiddle Continuous Performance Test 2nd EditionTM (K-CPT 2TM)

iii The timepoint(s) of primary interest

Week 0, Week 7, Week 13

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2022-02-08

27 Primary Registry and Trial Identifying Number

ChiCTR1800019013

28 Date of Registration in Primary Registry

2018-10-11

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Trial History Detail on 2020-12-15