Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00119

2 Trial Registration Date

2007-09-11

i Registration Status

Retrospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Departmental

5 Primary Sponsor

Department of Paediatrics, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Albert Martin Li

ii Address

iii Phone

Department of Paediatrics, PWH, Shatin, Hong Kong

iv Email

Telephone #: 26322859; Fax #: 26360020; email: albertm68mcli@yahoo.com

v Affiliation

vi Country

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

i Name

Albert Martin Li

ii Address

iii Phone

Department of Paediatrics, PWH, Shatin, Hong Kong

iv Email

Telephone #: 26322859; Fax #: 26360020; email: albertm68mcli@yahoo.com

v Affiliation

vi Country

9 Official Scientific Title of the Study

Nasal Corticosteroids as Treatment for Childhood Obstructive Sleep Apnoea.

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

N/A

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-03-02

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Childhood Obstructive Sleep Apnoea

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Nasonex

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

4 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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

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

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.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-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

2006-05-27

21 Target Sample Size

52

22 Recruitment Status

Recruiting

23 Primary Outcome

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

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-04

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2007-09-11