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

• Register: ChiCTR
• Last refreshed on: 14 October 2019
• Main ID: ChiCTR-TRC-10001136
• Date of registration: 2010-12-21
• Prospective Registration: Yes
• Primary sponsor: Department of Paediatrics, Chinese University, Hong Kong
• Public title: Effect of adenotonsillectomy on behavioural problems in children with mild obstructive sleep apnoea: a randomized controlled trial
• Scientific title: Effect of adenotonsillectomy on behavioural problems in children with mild obstructive sleep apnoea: a randomized controlled trial
• Date of first enrolment: 2010-12-28
• Target sample size: Two groups:100;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=8403
• Study type: Interventional study
• Study design: Parallel
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Mr. Au Chun Ting
• Affiliation: Department of Paediatrics, Falculty of Medicine, The Chinese University of Hong Kong

• Name: Dr. Albert Martin Li
• Affiliation: Department of Paediatrics, Falculty of Medicine, The Chinese University of Hong Kong

Key inclusion & exclusion 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: (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.
(x) Obese children, defined as having a BMI of >=95th percentile (corresponding to a z score of 1.645) of the local reference.

Age minimum: 6
Age maximum: 11
Gender: Both

Health Condition(s) or Problem(s) studied

Childhood obstructive sleep apnoea

Intervention(s)

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

Primary Outcome(s)

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

Secondary Outcome(s)

(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).;

Secondary ID(s)

CUHK_CCT00277

Source(s) of Monetary Support

Departmental Fund

Ethics review

Status: Approved
Approval date: 09/12/2011
Contact: