Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00277

2 Trial Registration Date

2010-12-21

iRegistration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

General Research Fund

5 Primary Sponsor

Department of Paediatrics, CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Dr. Albert Martin Li

ii Address

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

iii Phone

3505 2855

iv Email

albertmli@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

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

i Name

Mr. Au Chun Ting

ii Address

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

iii Phone

3505 2917

iv Email

junau@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

A randomized study of surgical intervention for mild childhood obstructive sleep apnoea – neurocognitive perspective

10 Public Title

Treatment effect of surgical intervention for mild childhood obstructive sleep apnoea – neurocognitive perspective

i Public Title in Chinese 研究名稱

手術治療對輕度阻塞性睡眠呼吸暫停綜合症兒童的認知功能之影響

11 Short Title (Optional)

Effect of T&A on neurocognitive outcomes in children with OSA: a RCT

12 Countries of Recruitment

Hong Kong

13Research 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

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2010.493

14 Medical Condition Being Studied

Childhood obstructive sleep apnoea

15Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Adenotonsillectomy

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

N/A

vi Frequency of the intervention

N/A

16Comparative 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

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17Key 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.
(x) Obese children, defined as having a BMI of ≥95th percentile (corresponding to a z score of 1.645) of the local reference.

iii Age Minimum

6 years old

iv Age Maximum

11 years old

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

Computer-generated code

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2010-12-28

21 Target Sample Size

120

22 Recruitment Status

Recruiting

23 Primary Outcome

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

24 Secondary Outcome

(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).

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last 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

Back History

Trial Detail