Obstructive sleep apnoea
Conditions
Interventions
A:lifestyle modification programme (LMP) + adenotonsillectomy LMP includes dietary restriction, physical activities and behavioural education to achieve weight reduction
B:adenotonsillectomy alone
Sponsors
Prince of Wales Hospital, Shatin, Hong Kong
Eligibility
Sex/Gender
Male
Age
7 Years to 12 Years
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete resolution of OSA at 6 months: defined as OAHI<1/hr; | — |
Secondary
| Measure | Time frame |
|---|---|
| (i) BMI at 6 months;(ii) 24-hour ambulatory blood pressure at 6 months;(iii) fasting glucose, insulin and lipid profile at 6 months; | — |
Countries
China
Contacts
Public ContactAlbert Martin Li
Outcome results
None listed