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

iRegistration 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

7Responsible 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

8Research 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

Should mild childhood obstructive sleep apnoea be treated? Investigation of the effect of early treatment versus watchful waiting on behavioral outcomes.

10 Public Title

Should mild childhood obstructive sleep apnoea be treated?

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Should mild childhood OSA be treated?

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2010-12-09

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Childhood obstructive sleep apnoea

15Intervention

i Types of intervention

Other

Please specify

The intervention will be tailor-made for each subject according to the study protocol

ii Description/ name of Intervention/article

An individualized treatment will be offered according to physical examination findings and pre-defined criteria in order to maximize the treatment efficacy and acceptability. Adenotonsillectomy (T&A) will be the treatment option for subjects who have a large tonsil and/or adenoid Turbinate reduction surgery will be additional in subjects found to have large turbinate plus nasal blockage symptom.
Remaining subjects who do not have a large tonsil and adenoid, and those refuse any surgical intervention, are prescribed nasal corticosteroids (budesonide 1 spray (32mcg) per nostril to be taken once daily) for a period of at least 4 months until repeat assessment. Anti-histamines including leukotriene receptor antagonist can also be prescribed during the treatment period for the control of concomitant allergic rhinitis symptoms. Subjects will be asked to complete a daily diary to encourage treatment compliance.
Subjects and parents will also be given an educational leaflet providing advice on lifestyle modification which includes healthy living and eating habits, regular exercise and sleep hygiene. Monthly telephone review by the research assistant will be arranged to ensure compliance with lifestyle modification and individual treatment plan (compliance with nasal corticosteroids, side effects encountered etc).
Obese subjects in the early treatment group will in addition be seen by a nutritionist who will prescribe an individualized balanced low-calorie diet. Regular follow-ups will be arranged once per month for 6 months. Telephone follow-ups will also be scheduled in the middle between 2 monthly visits.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

6 months

vi Frequency of the intervention

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

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

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) 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).

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

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

200

22 Recruitment Status

Not Yet 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.

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

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

n/a

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Trial History Detail on 2011-02-08