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Trial registered on ANZCTR


Registration number
ACTRN12618001093279
Ethics application status
Approved
Date submitted
15/05/2018
Date registered
29/06/2018
Date last updated
29/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing treatment outcomes of Adenoidectomy against medical therapies for mild obstructive sleep apnoea in children
Scientific title
A randomised trial of Adenoidectomy against medical therapies using polysomnography outcomes for mild obstructive sleep apnoea (OSA) in children
Secondary ID [1] 294892 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnoea 307846 0
mild OSA 307848 0
Condition category
Condition code
Respiratory 306891 306891 0 0
Sleep apnoea
Surgery 306892 306892 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(NS+LA) nasal steroid (mometasone)
I spray to each nostril daily administered by the parent
combined with a
leukotriene receptor antagonist (Singulair (4 or 5 mg) according to age).
One tablet per day, taken orally
Medications were provided by a trials pharmacist, including monitoring of returns..
Medication was provided without cost to all participants..
Treatment was used for 9.1 ± 2.2 months.
(AD) surgical adenoidectomy without tonsillectomy undertaken by a paediatric ear, nose and throat surgeon.
The procedure use was nasendoscopy and adenoidectomy by curettage and/or suction diathermy.
The procedure takes approximately 30 minutes.
Adenoidectomy was undertaken as a day-stay procedure under general anaesthetic in all cases. All procedures were undertaken under the guidance of one of the investigators.
Surgery was undertaken 5.4 ± 4.7 months after the diagnostic study
Follow-up studies were 6.1 ± 1.3 months after the surgery was undertaken
Intervention code [1] 301203 0
Treatment: Drugs
Intervention code [2] 301204 0
Treatment: Surgery
Comparator / control treatment
(NS) nasal steroid (mometasone) alone = (Nasonex junior 50 µg per spray).
I spray to each nostril daily,
Used for 7.3 ± 1.1 months.
Parents administered the spray.
Medications were provided by a trials pharmacist
Returns were monitored.
Medication was provided without cost to all participants.
Control group
Active

Outcomes
Primary outcome [1] 305887 0
OAHI = obstructive apnoea hypopnoea index per hour of sleep time.
This is assessed by polysomnography.
It documents the number of obstructive respiratory events (obstructive or mixed apnoeas and hypopnoeas) per hour of sleep time.
We used overnight polysomnography with measures of sleep stage (EEG, chin EMG, electromyography) and respiratory measures (airflow using nasal cannula and pressure transducer), respiratory effort (plethysmography, EMG of diaphragm and abdomen), SaO2 and TcCO2.
Measures were made at the time of recruitment and then at follow-up sleep studies.
Timepoint [1] 305887 0
Follow-up sleep study after at least 6 months of therapy (after starting medication)
Secondary outcome [1] 346890 0
Minimum SaO2 % (SaO2 nadir) from overnight polysomnography and after removal of artifact. Oxygen saturation measured with Nellcor N600X and a paediatric probe on the finger or foot, with digital acquisition of the signal at 16Hz with continuous recording of desaturation values. Values are summarised after manual removal of artefact from full polysomnography and summarised with baseline, minimum, average desaturations and oxygen desaturation indices,
Timepoint [1] 346890 0
follow-up sleep study was planned for 6 months after the intervention.
For the groups, the time points were:
NS = 7.3 ± 1.1 months
NS+LA = 9.1 ± 2.2 months
Ad = 6.1 ± 1.3 months
Secondary outcome [2] 346891 0
ODI = oxygen desaturation index per hour of sleep time taken from the overnight sleep study after removal of artifact. Oxygen saturation measured with Nellcor N600X and a paediatric probe on the finger or foot, with digital acquisition of the signal at 16Hz with continuous recording of desaturation values. Values are summarised after manual removal of artefact from full polysomnography and summarised with baseline, minimum, average desaturations and oxygen desaturation indices for 3% drops in SaO2,
Timepoint [2] 346891 0
at follow-up sleep study.
For the groups, the time points were:
NS = 7.3 ± 1.1 months
NS+LA = 9.1 ± 2.2 months
Ad = 6.1 ± 1.3 months
Secondary outcome [3] 346892 0
PSQ = paediatric sleep questionnaire. This is a 22-item, validated questionnaire for paediatric Sleep Related Breathing disorders, with subscales for snoring, sleepiness, and behaviour. Scores of = 8 positive answers has a three-fold increase in risk for OSA.
The total score of the PSQ was compared at follow-up compared to baseline, and amongst the treatment groups..
Timepoint [3] 346892 0
at follow-up review, with the follow-up sleep study.
For the groups, the time points were:
NS = 7.3 ± 1.1 months
NS+LA = 9.1 ± 2.2 months
Ad = 6.1 ± 1.3 months
Secondary outcome [4] 346896 0
Adenoid size by lateral airway x-ray (assessed using Hibbert method). This was evaluated by a paediatric radiologist who was blinded to the intervention.
Timepoint [4] 346896 0
x-rays were taken at the time of the baseline and the follow-up assessments, at the time of the overnight sleep studies.
For the groups, the time points were:
NS = 7.3 ± 1.1 months
NS+LA = 9.1 ± 2.2 months
Ad = 6.1 ± 1.3 months

Eligibility
Key inclusion criteria
Patients referred to either the sleep or ENT (ear, nose and throat) outpatient or inpatient services at a tertiary Children’s Hospital (CHW) were invited to participate in the study.
Minimum age
30 Months
Maximum age
10 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who had previously undergone adenotonsillectomy or airway surgery, who had high-risk genetic and craniofacial syndromes or neurodevelopmental conditions, and children with conditions that precluded adenoidectomy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated-randomisation of treatment was provided by our consulting statistician, and children were consecutively randomised to the next treatment allocation from that list until we had recruited 15 children to each of the treatment groups.
The randomization assignments were placed in sealed envelopes, which were opened when the child was recruited to the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation was computer-generated sequence generation by a statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects could not be blinded to the treatment being used, because one of the interventions involved surgical intervention.
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10894 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 22658 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 299475 0
Hospital
Name [1] 299475 0
The Children's Hospital at Westmead
Address [1] 299475 0
The Children's Hospital at Westmead
Corner Hawkesbury Rd and Hainesworth Street
Westmead
NSW 2145
Country [1] 299475 0
Australia
Primary sponsor type
Individual
Name
Prof. Karen Waters
Address
Sleep Medicine
The Children's Hospital at Westmead
Corner of Hawkesbury Rd and Hainesworth Street
Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 298776 0
Individual
Name [1] 298776 0
Ms Chenda Castro
Address [1] 298776 0
SIDS and Sleep Apnoea Research
The Children's Hospital at Westmead
Corner of Hawkesbury Rd, and Hainesworth St.,
Westmead, NSW 2145
Country [1] 298776 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300381 0
Children's Hospital at Westmead Human Ethics Research Committee
Ethics committee address [1] 300381 0
Research and Development
The Children's Hospital at Westmead
Corner of Hawkesbury Rd. and Hainesworth St.,
Westmead, NSW 2145
Ethics committee country [1] 300381 0
Australia
Date submitted for ethics approval [1] 300381 0
19/06/2003
Approval date [1] 300381 0
12/10/2003
Ethics approval number [1] 300381 0
2003/098
Ethics committee name [2] 300383 0
Sydney South West Area Health Service Human Research Ethics Committee
Ethics committee address [2] 300383 0
Sydney South West Area Health Service
Research Development Office
Level 8, Building 14,
Royal Prince Alfred Hospital
50 Missenden Rd,
Camperdown, NSW 2050
Ethics committee country [2] 300383 0
Australia
Date submitted for ethics approval [2] 300383 0
27/09/2006
Approval date [2] 300383 0
17/10/2006
Ethics approval number [2] 300383 0
X06-0210

Summary
Brief summary
Children diagnosed with mild obstructive sleep apnoea are enrolled and randomised to one of three treatment groups: 1) NS = with nasal steroids alone, 2) NS+AL = nasal steroids plus a leukotriene receptor antagonist, or 3) AD = to surgery with adenoidectomy alone. The aim was to determine whether treatment with surgery (adenoidectomy) or treatment with nasal steroids plus a leukotriene receptor antagonist has clear benefit compared to treatment with nasal steroids alone.. As steroids are routinely used as the first treatment in this disease, outcomes from the surgical and combined treatment (nasal steroid plus leukotriene receptor antagonist) groups will be compared against the group using nasal steroids alone (the comparison group).
Trial website
Trial related presentations / publications
A randomised trial of adenoidectomy against medical therapies for mild OSA in children. Kol-Castro C., Greenslade R., Jayachandra K.A.M.S., Cheng A., Waters K.A. Journal of Sleep Research 2016;25 (Suppl. 2);17
Public notes

Contacts
Principal investigator
Name 83474 0
Prof Karen A Waters
Address 83474 0
Sleep Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, NSW 2145
Country 83474 0
Australia
Phone 83474 0
+61 2 9845 3437
Fax 83474 0
+61 2 9845 3966
Email 83474 0
karen.waters@health.nsw.gov.au
Contact person for public queries
Name 83475 0
Ms Chenda Castro
Address 83475 0
Manager,
Sleep Unit
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, NSW 2145
Country 83475 0
Australia
Phone 83475 0
+61 2 9845 0900
Fax 83475 0
+61 2 9845 2109
Email 83475 0
Chenda.castro@health.nsw.goc.au
Contact person for scientific queries
Name 83476 0
Prof Karen A Waters
Address 83476 0
Sleep Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, NSW 2145
Country 83476 0
Australia
Phone 83476 0
+61 2 9845 3437
Fax 83476 0
+61 2 9845 3966
Email 83476 0
karen.waters@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary