Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00397

2 Trial Registration Date

2014-02-28

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.683-T

4 Source(s) of Funding

Department of Paediatrics, CUHK

5 Primary Sponsor

Department of Paediatrics, CUHK

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Mr. Au Chun Ting

ii Address

RM 94034, 7/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China

iii Phone

2632 2917

iv Email

junau@cuhk.edu.hk

v Affiliation

Department of Paediatrics, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

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

i Name

Prof. Albert Martin Li

ii Address

Department of Paediatrics, 6/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T.

iii Phone

2632 2982

iv Email

albertmli@cuhk.edu.hk

v Affiliation

Department of Paediatrics, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A randomized controlled study of the effect of changes in bedtime on blood pressure in children and adolescents

10 Public Title

Effect of bedtime changes on blood pressure in children and adolescents

i Public Title in Chinese 研究名稱

改變睡眠時間對兒童及青少年的血壓之影響－隨機交叉研究

11 Short Title (Optional)

Effect of bedtime changes on BP

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-01-15

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Sleep deprivation

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Subjects in group A will be instructed to extend their time in bed (TIB) by 1h from baseline in study week 1, and to further increase their TIB by another hour in study week 2. They will then be instructed to maintain the increased TIB for two more weeks (study weeks 3 and 4).

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

4 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Subjects in group B will be instructed to maintain their time in bed (TIB) as in the baseline week for two more weeks (study weeks 1 and 2). They will then need to extend their TIB by 1h in study week 3 and further extend by another hour in study week 4.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Children and adolescents aged between 6-18 years;
2. Parent- or self-reported time in bed of <7 hours/night;
3. Normal weight (Body mass index <85th percentile of local norm);
4. Non-hypertensive (clinic BP <95th percentile of local norm);
5. Written informed consent and assent obtained from parents and children.

ii Exclusion Criteria

1. Diagnosis of a medical or psychiatric condition or use of current medication that may affect sleep and BP;
2. Parent reports habitual snoring (≥3 nights per week in the past 12 months).

iii Age Minimum

6 years old

iv Age Maximum

18 years old

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-03-15

21 Target Sample Size

40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

24-hour ambulatory systolic and diastolic blood pressure at the end of study

24 Secondary Outcome

Actigraphy measured sleep quantity and quality at the end of study

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-04-01

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004316

28 Date of Registration in Primary Registry

2014-03-03

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

n/a

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Trial History Detail on 2014-04-07