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Trial Detail

CUHK_CCRB00627

2018-10-11

Prospective

CREC Ref.NO.: 2018.222-T

Departmental funding

Department of Paediatrics, CUHK

N/A

Not Applicable

Chun-Ting Au

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

35052917

junau@cuhk.edu.hk

Department of Paediatrics

Hong Kong SAR, China

Albert Marin Li

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

26322982

albertmli@cuhk.edu.hk

Department of Paediatrics

Hong Kong SAR, China

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

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

教育家長對改善學前兒童睡眠的成效 - 隨機對照研究

Hong Kong SAR, China

Yes

2018-05-15

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC Ref.NO.: 2018.222-T

Short sleep duration

Behavior

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.

Workshop and telephone interview

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

7 weeks

Weekly

Continue with their usual bedtime schedules

Telephone interview

7

7 weeks

Weekly

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

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.

3

5

Both Male and Female

Interventional

Randomized

Randomised controlled study

Active

Single-blind

Investigator/research team

Parallel

2

Prolong children sleep duration

2018-11-01

200

Recruiting

Sleep duration

Actigraphy and sleep diary

Week 0, Week 7, Week 13

Sleep efficiency,

Actigraphy

Week 0, Week 7, Week 13

Wake after sleep onset (WASO)

Actigraphy

Week 0, Week 7, Week 13

Sleep latency

Actigraphy

Week 0, Week 7, Week 13

Behavioural problem score

Child Behaviour Checklist (CBCL)

Week 0, Week 7, Week 13

Sleep problem score

Children Sleep Habit Questionnaire (CSHQ)

Week 0, Week 7, Week 13

Objective measures of attention

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

Week 0, Week 7, Week 13

No

2020-12-15

ChiCTR1800019013

2018-10-11

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