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Trial History Detail on 2015-06-23

CUHK_CCT00413

2014-05-22

Prospective

CRE-2014.038-T

Department of Paediatrics, CUHK

Department of Paediatrics, CUHK

N/A

Dr Dorothy FY Chan

Department of Paediatrics, 6/F, Lui Che Woo Clinical Sciences, PWH

26322982

dorothychan@cuhk.edu.hk

The Chinese University of Hong Kong

Dr Dorothy FY Chan

Department of Paediatrics, 6/F, Lui Che Woo Clinical Sciences, PWH

26322982

dorothychan@cuhk.edu.hk

The Chinese University of Hong Kong

A pilot study of surgical intervention for childhood obstructive sleep apnoea – neurocognitive function

Surgical intervention for childhood OSA - Neurocognitive function

手術治療對阻塞性睡眠呼吸暫停綜合症兒童的心智綜合功能之影響

Surgical intervention for childhood OSA - Neurocognitive function

Hong Kong

Yes

2014-03-24

Childhood obstructive sleep apnoea

Other

Surgical intervention

Adenotonsillectomy (AT) will be offered as a treatment of OSA for this group of subjects. Turbinate reduction procedure will also be performed if the subject has current history of allergic rhinitis and examination reveals at least grade II turbinate hypertrophy. (Grade I is no turbinate hypertrophy; Grade II is turbinate hypertrophy without touching the septum; Grade III is turbinate hypertrophy and it touches the septum). The procedure will be performed by an experienced ENT surgeon within 4-6 weeks post randomization. Subjects allocated to this group will be reassessed 6 months after surgery.

6 months

Watchful waiting group
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.

(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 grading11≥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.
(v) Severe health problems that could be exacerbated by delayed treatment of OSA, for example chronic lung disease.

5

11

Both Male and Female

Interventional

Randomized

Not Applicable

Single-blind

Parallel

2014-06-06

130

Unknown

To examine whether surgical intervention would lead to improvements in neurocognitive function in children with OSA, and to what extent the neurocognitve deficits are reversible.

To examine the effects of surgical intervention on indexes of disease severity and symptoms in children with OSA.

No

2015-06-23

ChiCTR-TRC-14004709 

2014-05-28


No

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