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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001136
Enrollment
Unknown
Registered
2010-12-21
Start date
2010-12-28
Completion date
Unknown
Last updated
2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood obstructive sleep apnoea

Interventions

Two groups:Adenotonsillectomy versus close monitoring and direct contact of the research team if necessary

Sponsors

Department of Paediatrics, Chinese University, Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 11 Years

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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 =95th percentile (corresponding to a z score of 1.645) of the local reference.

Design outcomes

Primary

MeasureTime frame
Omission T score of Conners’ continuous performance test (CPT) at 6 months.;

Secondary

MeasureTime frame
(i) Polysomnographic changes.;(ii) 24-hr blood pressure.;(iii) Attention, assessed by Test of Everyday Attention for Children (TEA-Ch).;(iv) Commission and reaction time T scores of CPT.;(v) Working memory.;(vi) Executive function;(vii) Non-verbal reasoning;(viii) Quality of life;(ix) Child Behavior Checklist (CBCL).;(x) Teacher’s Report Form (TRF).;(xi) Symptoms of attention deficiency / hyperactivity disorder (ADHD) assessed by ADHD rating scale-IV parents version (investigator administered) [3];(xii) Daytime sleepiness assessed by a Chinese version of the Pediatric Daytime Sleepiness Scale (PDSS). [4];(xiii) Fasting insulin and glucose, serum lipid profile and serum inflammatory marker; high sensitive CRP (hs-CRP).;

Countries

China

Contacts

Public ContactMr. Au Chun Ting

Department of Paediatrics, Falculty of Medicine, The Chinese University of Hong Kong

junau@cuhk.edu.hk+852 2632 2917

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026