Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00413

2 Trial Registration Date

2014-05-22

i Registration Status

Prospective

3 Secondary IDs

CRE-2014.038-T

4 Source(s) of Funding

Department of Paediatrics, CUHK

5 Primary Sponsor

Department of Paediatrics, CUHK

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Dr Dorothy FY Chan

ii Address

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

iii Phone

26322982

iv Email

dorothychan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Dr Dorothy FY Chan

ii Address

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

iii Phone

26322982

iv Email

dorothychan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

Surgical intervention for childhood OSA - Neurocognitive function

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智綜合功能之影響

11 Short Title (Optional)

Surgical intervention for childhood OSA - Neurocognitive function

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?

2014-03-24

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

Other

Please specify

Surgical intervention

ii Description/ name of Intervention/article

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.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

6 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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.

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

(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.

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

iii Age Minimum

5

iv Age Maximum

11

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Single-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

2014-06-06

21 Target Sample Size

130

22 Recruitment Status

Unknown

23 Primary Outcome

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.

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-06-23

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004709

28 Date of Registration in Primary Registry

2014-05-28

Back History

Trial Detail