Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00306

2 Trial Registration Date

2011-11-24

i Registration Status

Prospective

3 Secondary IDs

none

4 Source(s) of Funding

Departmental funding

5 Primary Sponsor

Department of Paediatrics

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Au Chun Ting

ii Address

Department of Paediatrics, 6th Floor, Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

26322917

iv Email

junau@cuhk.edu.hk

v Affiliation

Department of Paediatrics, Faculty of Medicine, CUHK

vi Country

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

i Name

Albert Martin Li

ii Address

Department of Paediatrics, 6th Floor, Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

26322982

iv Email

albertmli@cuhk.edu.hk

v Affiliation

Department of Paediatrics, Faculty of Medicine, CUHK

vi Country

9 Official Scientific Title of the Study

The effect of weight reduction on obstructive sleep apnoea in obese
children: a randomized controlled study

10 Public Title

The effect of weight reduction on obstructive sleep apnoea in obese
children: a randomized controlled study

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Weight reduction in obese children with obstructive sleep apnoea

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?

2011-11-03

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Obstructive sleep apnoea

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

lifestyle modification programme (LMP) + adenotonsillectomy
LMP includes dietary restriction, physical activities and behavioural education to achieve weight reduction.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

lifestyle modification programme (LMP): 6 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

adenotonsillectomy alone

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 7–12 years;
(ii) Diagnosis of OSA defined as: obstructive apnoea hypopnoea index (OAHI) ≥ 1/hr confirmed on PSG and parental report of habitual snoring and at least one other OSA-related symptom;
(iii) Defined as obese: BMI will be converted to BMI z score, according to the local normal reference. Children will be defined as obese if their BMI z sore ≥ 1.65, corresponding to the 95th percentile (relative to age and gender);
(iv) Tonsillar hypertrophy ≥ 1 based on a standardized scale of 0–4: 0 = surgically absent; 1 = taking up 0- 25% of the airway; 2 = 25–50% of the airway; 3 = 50–75% of the airway; and 4 = > 75% of the airway;
(v) Deemed to be a surgical candidate for AT by Ear, Nose & Throat (ENT) evaluation; and
(iv) Written informed consent obtained from parents.

ii Exclusion Criteria

(i) OSA associated with other medical disorders, including Downs syndrome, craniofacial anomalies and neuromuscular disease;
(ii) Defined as severely obese: BMI will be converted to BMI z score, according to the local normal reference. Children will be defined as severely obese if their BMI z score ≥ 2.33, corresponding to the 99th percentile (relative to age and gender);
(iii) Previous upper airway surgery on the nose, pharynx or larynx, including tonsillectomy;
(iv) Receiving CPAP treatment;
(v) Concurrent participation in any other weight loss programme;
(vi) Current use of one or more of the following medications: psychotropics; hypnotics; hypoglycemic agents or insulin; antihypertensives; growth hormone; anticonvulsants; anti-coagulants; daily oral corticosteroids; and daily medications for pain and weight reducing agent;
(vii) Chronic health conditions including: cardiopulmonary disorders; anaemia; epilepsy requiring medication; diabetes (type I or type II) requiring medication; conditions likely to preclude accurate PSG (e.g., severe uncontrolled pain); mental retardation; and chronic infection;
(viii) Parents refuse AT; and
(ix) Unwillingness to participate in LMP

iii Age Minimum

7 years

iv Age Maximum

12 years

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

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

2012-04-01

21 Target Sample Size

180

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Complete resolution of OSA at 6 months: defined as OAHI<1/hr

24 Secondary Outcome

(i) BMI at 6 months
(ii) 24-hour ambulatory blood pressure at 6 months
(iii) fasting glucose, insulin and lipid profile at 6 months

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-08-17

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001795

28 Date of Registration in Primary Registry

2011-12-14

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2012-02-28