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Trial History Detail on 2011-11-24

CUHK_CCT00306

2011-11-24

Prospective

none

Departmental funding

Department of Paediatrics

N/A

Au Chun Ting

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

26322917

junau@cuhk.edu.hk

Department of Paediatrics, Faculty of Medicine, CUHK

Albert Martin Li

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

26322982

albertmli@cuhk.edu.hk

Department of Paediatrics, Faculty of Medicine, CUHK

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

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

Weight reduction in obese children with obstructive sleep apnoea

Hong Kong

Yes

2011-11-03

Obstructive sleep apnoea

Procedure

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

lifestyle modification programme (LMP): 6 months

adenotonsillectomy alone

(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.

(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

7 years

12 years

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2012-04-01

180

Not Yet Recruiting

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

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

No

2015-08-17


Yes

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