Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00386

2 Trial Registration Date

2014-01-13

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.599

4 Source(s) of Funding

General Research Fund

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

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

Hong Kong

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

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

Hong Kong

9 Official Scientific Title of the Study

A randomized study of surgical intervention for childhood obstructive sleep apnoea - cardiovascular perspective

10 Public Title

Surgical intervention for childhood obstructive sleep apnoea

i Public Title in Chinese 研究名稱

手術治療對阻塞性睡眠呼吸暫停綜合症兒童的心血管健康之影響

11 Short Title (Optional)

Surgical intervention for childhood OSA

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?

2013-12-13

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2013.599

14 Medical Condition Being Studied

Childhood obstructive sleep apnoea

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Adenotonsillectomy +/- Turbinate reduction

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

Subjects will be reassessed 6 months after the date of surgery

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

Watchful waiting:
Children allocated to this group will not receive any form of intervention. This is similar to our current practice where children diagnosed with OSA and planned for surgery will have to wait for between 5-6 months before the procedure. At the end of the study, early intervention will be offered for children whose OSA remains as moderate-to-severe. Subjects allocated to this group will be reassessed 7 months after the baseline visit.

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(i) Hong Kong Chinese pre-pubertal children aged between 5-11 years.
(ii) Moderate-to-severe OSA confirmed by PSG (OAHI > 5).
(iii) Tonsil size grading ≥1 and considered to be candidates for surgical intervention by ENT surgeon.
(iv) Written informed consent obtained from parents.

ii Exclusion Criteria

(i) Obesity, defined as having a body mass index (BMI) ≥95th percentile (corresponding to a z score of 1.645) of the local reference.
(ii) Previous upper airway surgery or currently receiving treatment for OSA.
(iii) Known medical conditions that could affect airway and BP control, for example cranio-facial, neuromuscular diseases and congenital heart disease.
(iv) Receiving medications that could alter BP control.
(v) Severe health problems that could be exacerbated by delayed treatment of OSA, for example chronic lung disease.

iii Age Minimum

5 years old

iv Age Maximum

11 years old

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Computer-generated code

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

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-01-27

21 Target Sample Size

130

22 Recruitment Status

Recruiting

23 Primary Outcome

24-hour ambulatory blood pressure parameters

24 Secondary Outcome

Polysomnographic indexes, including obstructive apnoea hypopnoea index (OAHI) and respiratory disturbance index (RDI), and symptoms of obstructive sleep apnoea.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-09-06

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004131

28 Date of Registration in Primary Registry

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Trial History Detail on 2016-05-04