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CUHK_CCT00277
2010-12-21
Prospective
Nil
Departmental Fund
Department of Paediatrics, CUHK
N/A
Dr. Albert Martin Li
Department of Paediatrics, 6/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T.
2632 2855
albertmli@cuhk.edu.hk
Department of Paediatrics, Falculty of Medicine, The Chinese University of Hong Kong
Mr. Au Chun Ting
Department of Paediatrics, 6/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T.
2632 2917
junau@cuhk.edu.hk
Department of Paediatrics, Falculty of Medicine, The Chinese University of Hong Kong
Should mild childhood obstructive sleep apnoea be treated? Investigation of the effect of early treatment versus watchful waiting on behavioral outcomes.
Should mild childhood obstructive sleep apnoea be treated?
Should mild childhood OSA be treated?
Hong Kong
Yes
2010-12-09
Childhood obstructive sleep apnoea
Other
The intervention will be tailor-made for each subject according to the study protocol
An individualized treatment will be offered according to physical examination findings and pre-defined criteria in order to maximize the treatment efficacy and acceptability. Adenotonsillectomy (T&A) will be the treatment option for subjects who have a large tonsil and/or adenoid Turbinate reduction surgery will be additional in subjects found to have large turbinate plus nasal blockage symptom.
Remaining subjects who do not have a large tonsil and adenoid, and those refuse any surgical intervention, are prescribed nasal corticosteroids (budesonide 1 spray (32mcg) per nostril to be taken once daily) for a period of at least 4 months until repeat assessment. Anti-histamines including leukotriene receptor antagonist can also be prescribed during the treatment period for the control of concomitant allergic rhinitis symptoms. Subjects will be asked to complete a daily diary to encourage treatment compliance.
Subjects and parents will also be given an educational leaflet providing advice on lifestyle modification which includes healthy living and eating habits, regular exercise and sleep hygiene. Monthly telephone review by the research assistant will be arranged to ensure compliance with lifestyle modification and individual treatment plan (compliance with nasal corticosteroids, side effects encountered etc).
Obese subjects in the early treatment group will in addition be seen by a nutritionist who will prescribe an individualized balanced low-calorie diet. Regular follow-ups will be arranged once per month for 6 months. Telephone follow-ups will also be scheduled in the middle between 2 monthly visits.
6 months
Parents in this group will be given instructions to allow close monitoring of their child for any disease deterioration as reflected by worsening of symptoms such as loud snoring, allergic rhinitis symptoms, daytime sleepiness, inattention and hyperactivity problems, recurrent tonsillitis or other upper airway infections. They will also be provided with direct contact of the research team, and an earlier appointment for follow-up will be scheduled if necessary.
(i) Hong Kong Chinese prepubertal children aged between 6-11 years.
(ii) Mild OSA confirmed by nocturnal PSG (obstructive apnoea hypopnoea index (OAHI) between 1 and 5) and parental report of habitual snoring (at least 3 nights per week).
(iii) Written informed consent obtained from parents.
(i) Previous upper airway surgery.
(ii) Diagnosed to have attention deficit hyperactivity disorder (ADHD) or other psychiatric behavioural problems.
(iii) Craniofacial anomalies.
(iv) Severe health problems that could be exacerbated by delayed treatment of OSA.
(v) SpO2 nadir <90% in nocturnal PSG.
(vi) Receiving any forms of treatment for OSA.
(vii) Receiving any medications for allergic rhinitis including nasal corticosteroids and antihistamines within 6 weeks from baseline PSG.
(viii) Parental report that child has reached menarche (female participants).
6 years old
11 years old
Both Male and Female
Interventional
Randomized
Active
Single-blind
Parallel
2010-12-28
200
Not Yet Recruiting
Behavioural and psychosocial changes, assessed by Child Behavior Checklist (CBCL) at 6 months.
(i) Polysomnographic data at 6 months.
(ii) 24-hr blood pressure at 6 months.
(iii) Attention, assessed by Conners’ Continuous Performance Test II (CPT-II) at 6 months .
(iv) Symptoms of attention deficiency / hyperactivity disorder (ADHD) assessed by ADHD rating scale-IV parents version (investigator administered) at 6 months.
(v) Daytime sleepiness assessed by the modified Epworth Sleepiness Scale (ESS) at 6 months.
(vi) Fasting insulin and glucose, serum lipid profile and serum inflammatory marker; high sensitive CRP (hs-CRP) at 6 months.
2019-09-06
Yes
n/a
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