None listed
Conditions
Brief summary
This is a 5-year multicenter trial. Children with a history suggestive of OSA and deemed suitable for adenotonsillectomy (T&A) by an otolaryngologist are eligible to participate in an overnight sleep study (PSG). If the PSG demonstrates mild to moderate OSA OAHI< 10/hr), they will be recruited randomised to receive early (treatment group), or routine (control group) adenotonsillectomy (treatment intervention).The outcome sought is a clinically meaningful improvement in the neurocognitive testing scores, which has been defined as an improvement of 4 IQ points. The primary outcome of the study are intelligence quotient (IQ) and behavioural scores. The IQ and behaviour will be assessed after the PSG result but before randomisation. The PSG, IQ and behaviour tests will be repeated at follow-up 12 months later. After follow-up at 12 months, the control group will proceed to T&A and at 24 months, the treatment and the control groups will have PSG, IQ and behaviour tests repeated for the third time. Rationale: Previous studies have demonstrated that children with OSA have lower IQ scores and more disturbed behaviour than age-matched counterparts who do not snore. No randomized trials have been undertaken to evaluate whether the abnormalities improve after treatment. The participants in this study will have overnight sleep studies and neuropsychological testing at three time points. The first is at baseline before T&A. One group will have T&A after randomisation and the first follow-up (12 months after randomisation) will assess changes for treatment (T&A) vs non-treatment (waiting). after 12 months follow-up, the second group will also undergo T&A. The second assessment (24 months after randomisation) whether a 12 month delay to T&A affects outcomes. The first assessment will allow us to determine whether adenotonsillectomy (T&A) improves IQ and behavioural deficits in 3-5 yr-old children compared to no T&A. We hypothesize that T&A produces improvements in IQ and in behaviour. The second assessment will allow us to determine whether there is any difference in the level of improvement achieved after early compared to late (12 month delayed) T&A.
Interventions
This is a prospective randomised controlled trial in adenotonsillectomy in preschool aged children with mild to moderate OSA. Children will be randomised into either the "Early Intervention" group (early surgery - adenotonsillectomy within two months of randomisation) or "Delayed Intervention" group (usual 12 month surgical wait list for adenotonsillectomy). Children will also undergo the following tests at baseline, 12 months and 24 months: polysomnography, lateral airways x-ray, IQ and behavio
This is a prospective randomised controlled trial in adenotonsillectomy in preschool aged children with mild to moderate OSA. Children will be randomised into either the "Early Intervention" group (early surgery - adenotonsillectomy within two months of randomisation) or "Delayed Intervention" group (usual 12 month surgical wait list for adenotonsillectomy). Children will also undergo the following tests at baseline, 12 months and 24 months: polysomnography, lateral airways x-ray, IQ and behavioural testing. Intervention is Adenotonsillectomy surgery, which is a standardised surgical technique. All children will undergo complete extra-capsular tonsillectomy and adenoidectomy, regardless of the size of the adenoids. The adenoidal bed will be visualized at the end of the procedure, to ensure the adenoidectomy is satisfactorily complete. It has been agreed that diathermy for adenoids is acceptable. This is a 5 year study. Recruitment will last over a period of 5 years, in case of patient drop out from the study. However, each participant is seen upto 24 months after surgery.
Sponsors
The Children's Hospital at Westmead
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
3 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
Children with enlarged adenoids and tonsils and are suitable for adenotonsillectomy.
Exclusion criteria
Children with medical conditions known to affect neurocognitive development (including hearing loss of >35 DB) in both ear, previous tonsillectomy or airway surgery, genetic and craniofacial syndromes that are known to have high risk for severe OSA, identified neurodevelopmental conditions, cyanotic heart disease or previous cardiopulmonary bypass, and conditions that preclude neurocognitive testing such as not able to understand and speak age appropriate English will be excluded from enrolment in the study. Children found to have severe OSA OAHI >10/h) on sleep study will be excluded because it is considered unethical to delay treatment in this group, who have risk for morbidities other than neurocognitive deficit
Outcome results
None listed