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Trial History Detail on 2011-04-04

CUHK_CCT00119

2007-09-11

Retrospective

N/A

Departmental

Department of Paediatrics, The Chinese University of Hong Kong

N/A

Albert Martin Li

Department of Paediatrics, PWH, Shatin, Hong Kong

Telephone #: 26322859; Fax #: 26360020;

albertm68mcli@yahoo.com

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

Albert Martin Li

Department of Paediatrics, Prince of Wales Hospital, Shatin, Hong Kong

Telephone #: 26322859; Fax #: 26360020;

albertm68mcli@yahoo.com

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

Nasal Corticosteroids as Treatment for Childhood Obstructive Sleep Apnoea.

Nasal Corticosteroids as Treatment for Childhood Obstructive Sleep Apnoea.

N/A

Hong Kong SAR

Yes

2004-03-02

Childhood Obstructive Sleep Apnoea

Drug

Nasonex

4 months

Placebo. The appearance and smell of the corticosteroids and placebo are indistinguishable.

Inclusion criteria: Once the subjects have completed the overnight PSG, they will be invited to participate in this current study if they satisfied the followings: (1) Confirmed OSAS with a respiratory disturbance index (RDI) of between 1 and 10. It is our current practice to offer children with moderate-severe OSAS (RDI > 10) surgical intervention in the form of adeno-tonsillectomy. (2) Informed consent obtained from parents.

Exclusion criteria: (1) Children with genetic syndromes, congenital or acquired neurological diseases, neuromuscular diseases, and those who have had previous upper airway surgery. (2) Children with fixed nasal obstruction such as previous nasal fracture or deviated nasal septum.

6

18

Both Male and Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2006-05-27

52

Complete

The primary outcome is the change from baseline the various respiratory parameters as documented by overnight polysomnography after a 4-month treatment.

The secondary outcome is the change from baseline the adenoidal size as assessed by standardized lateral neck radiograph after a 4-month treatment.

No

2011-04-04

ChiCTR-TRC-09000700

2010-05-04


Yes

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