Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00277

2 Trial Registration Date

2010-12-21

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Departmental Fund

5 Primary Sponsor

Department of Paediatrics, CUHK

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. Albert Martin Li

ii Address

Department of Paediatrics, 6/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T.

iii Phone

2632 2855

iv Email

albertmli@cuhk.edu.hk

v Affiliation

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

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Mr. Au Chun Ting

ii Address

Department of Paediatrics, 6/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T.

iii Phone

2632 2917

iv Email

junau@cuhk.edu.hk

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

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

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-12-09

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Childhood obstructive sleep apnoea

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Adenotonsillectomy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Subjects will have repeated assessment 6 months after adenotonsillectomy

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i 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.

ii 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.

iii Age Minimum

6 years old

iv Age Maximum

11 years old

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2010-12-28

21 Target Sample Size

100

22 Recruitment Status

Recruiting

23 Primary Outcome

Behavioural and psychosocial changes, assessed by Child Behavior Checklist (CBCL) at 6 months.

24 Secondary Outcome

(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.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-09-06

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-10001136

28 Date of Registration in Primary Registry

2011-01-01

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

n/a

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Trial History Detail on 2012-10-25