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Trial History Detail on 2016-05-04

CUHK_CCT00386

2014-01-13

Prospective

CRE-2013.599

General Research Fund

Department of Paediatrics, CUHK

N/A

Not Applicable

Mr. Au Chun Ting

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

2632 2917

junau@cuhk.edu.hk

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

Hong Kong

Mr. Au Chun Ting

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

2632 2917

junau@cuhk.edu.hk

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

Hong Kong

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

Surgical intervention for childhood obstructive sleep apnoea

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

Surgical intervention for childhood OSA

Hong Kong

Yes

2013-12-13

Joint CUHK-NTEC Clinical Research Ethics Committee

CRE-2013.599

Childhood obstructive sleep apnoea

Procedure

Adenotonsillectomy +/- Turbinate reduction

N/A

N/A

Subjects will be reassessed 6 months after the date of surgery

N/A

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.

N/A

N/A

N/A

N/A

(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.

(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.

5 years old

11 years old

Both Male and Female

Interventional

Randomized

Computer-generated code

Active

Single-blind

Investigator/research team

Parallel

4

2014-01-27

130

Recruiting

24-hour ambulatory blood pressure parameters

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

No

2019-09-06

ChiCTR-TRC-14004131

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