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Trial History Detail on 2012-10-25

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

Effect of adenotonsillectomy on behavioural problems in children with mild obstructive sleep apnoea: a randomized controlled trial

Effect of adenotonsillectomy on behavioural problems in children with mild obstructive sleep apnoea: a randomized controlled trial

Effect of T&A on behavioural problems in children with OSA: a RCT

Hong Kong

Yes

2011-12-09

Childhood obstructive sleep apnoea

Procedure

Adenotonsillectomy

Subjects will have repeated assessment 6 months after adenotonsillectomy

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) Tonsil size grading ≥1.
(iv) 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).
(ix) Refusal of the surgical procedures.

6 years old

11 years old

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2010-12-28

100

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.

No

2019-09-06

ChiCTR-TRC-10001136

2011-01-01


Yes

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