Does Sleep Disordered Breathing in Pre School Age Children Cause Cognitive Weakness Reversible by Adenotonsillectomy? A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Cognition
研究概览
简要总结
Sleep disorder breathing (SDB) is a condition affecting 10% of children aged 2-6 years. It is a combination of snoring most nights during sleep, patchy sleep, short periods of stopping breathing (apnoea) and usually big tonsils. Most of these children get better with no treatment by 8 years old. It has been suggested that having SDB mean that some children concentrate and behave less well during the day and may learn more slowly than children who don't snore. It has become common for many Ear, Nose and Throat (ENT) surgeons to take out tonsils and adenoids (adenotonsillectomy) for this condition. Removing the tonsils and adenoids (which are normally big at this age) means that most children quickly stop snoring and seem to be cured. Unfortunately it is not clear if this operation makes any difference to learning compared to just watching the child and letting them "grow out" of the condition (watchful waiting).
There is no set treatment in the UK today. Children may be offered adenotonsillectomy or watchful waiting; it is not know which, long term, is the right thing to do. Therefore the investigators wish to do a study looking at these two different treatments to see if there is a difference in children's learning over time between the two different treatments. The investigators will look at children with SDB, measure their learning (and behaviour) and then randomly select which children get one treatment or the other. They will then re-measure learning (and behaviour) 7 months later to see if there is any difference between the two groups. The investigators will also scientifically measure their sleep. This is possibly quite a difficult study to do, the investigators are unsure whether families will agree to take part and how easy it will be to measure learning with such young children (aged 2:6 - 5).
详细描述
Purpose and Design. Large numbers of children snore on a regular basis in UK. It is known that habitual snoring is associated with cognitive weakness but not known if it is the cause of cognitive weakness. Teenagers who snored at a young age do less well at school than peers, who did not snore at a young age, but it is not known if this is due to the snoring or multiple other confounding factors.
More than 60% of children who snore regularly at 3 years of age have stopped regularly snoring by 7 years of age. They grow out of SDB with no active treatment. If their tonsils and adenoids are removed 80% will immediately stop snoring (and will be cured). Research shows that if tonsils and adenoids are removed at 6-8 years old, there is no difference in cognitive abilities between the group who had adenotonsillectomy and those that did not.
It is not known if several years of habitual snoring, sleep fragmentation and recurrent short-lived episodes of hypoxia cause minor changes to the developing brain causing cognitive weakness. Therefore it is not known if taking tonsils and adenoids out at a young age (2-4 years) when they first start snoring, thus avoiding several years of habitual snoring, sleep fragmentation and recurrent mild hypoxia, makes a difference to cognition in the future. It is not known if a period of a number of years of habitual snoring (with possible sleep fragmentation and recurrent episodes of hypoxia) causes irreversible cognitive weakness, reversible cognitive weakness or no cognitive weakness at all.
35,000 children undergo adenotonsillectomy in England and Wales per year with the second most common indication being SDB (habitual snoring and other features of recurrent upper airway obstruction).
The balance of benefits versus detrimental effects of adenotonsillectomy in children with SDB is not accurately known. The detrimental effects are well known. They include significant pain for at least 7 days for most children, bleeding after the operation in 1%, and very, very rarely death. The benefits are less clear. Adenotonsillectomy in pre-school age children with SDB results in improved behaviour and quality of life scores in the short term but it is not known if there is an effect on cognition. The effect of adenotonsillectomy on cognitive development versus the effect of watchful waiting with supportive care (treatment of associated conditions such as chronic otitis media with effusion and rhinitis) needs investigation, if clinicians are to give families a true description of advantages and disadvantages of surgery for SDB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged more than 2 years 6 months and less than 5 years of age at time of recruitment
- •A diagnosis of SDB based on clinical criteria.
- •Enlarged tonsils on examination (2 or more on standard Brodsky scale)
排除标准
- •Recurrent tonsillitis as main symptoms leading to consideration for AT
- •Known genetic, cranio-facial or psychiatric condition likely to affect airway, cognition or behaviour
- •Obesity (Body Mass Index > 2.5 standard deviation from mean for age and gender)
- •Severe OSA (Apnoea Hypopnoea Index greater than 30 / hour on sleep study)
- •Severe chronic health conditions that may hamper participation. This may include severe congenital heart disease, cystic fibrosis, sickle cell anaemia, or poorly controlled epilepsy)
- •A history of significant hypertension (defined as greater than the 99th percentile (CDC prediction equations) plus 5mmHg for either systolic or diastolic.
- •Concurrent use of ADHD medicines, psychotropic medications (anti-depressants, anxiolytics, anti-psychotics), hypnotics or anti convulsants.
- •Previous adenotonsillectomy, tonsillectomy or adenoidectomy.
- •Receiving Continuous Positive Airway Pressure as a treatment
- •A parent or Guardian who is unable to read and thus understand the consent form.
- •A family planning to move out of the area within the next 9 months.
- •Severe snoring since birth.
研究组 & 干预措施
Adenotonsillectomy
Removal of tonsils and adenoids under a general anaesthetic
干预措施: Adenotonsillectomy (Procedure)
Watchful waiting with supportive care
Reassurance with active medical treatment of conditions associated with Sleep Disordered Breathing such as otitis media with effusion and allergic rhinitis
干预措施: Watchful waiting with supportive care (Drug)
结局指标
主要结局
Cognition
时间窗: 8 months
Weschler Pre-School and Primary Scale of Intelligence (WPPSI) The full Score IQ measures of each of the two groups will be compared at baseline (to ensure no group differences at the start) and again at the end of the study period. Any difference at the end of the study period will provide information to answer the key study question, and potentially to power a larger definitive study.
次要结局
未报告次要终点
研究者
Mike Tremlett
Consultant Anaesthetist
South Tees Hospitals NHS Foundation Trust