Sleep Disordered Breathing, Adenotonsillectomy, Cognition and Pre-school Age Children

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: South Tees Hospitals NHS Foundation Trust
• Collaborator: University of Leeds

Criteria

Inclusion Criteria:

1. Aged more than 2 years 6 months and less than 5 years of age at time of recruitment

2. A diagnosis of SDB based on clinical criteria.

3. Enlarged tonsils on examination (2 or more on standard Brodsky scale)

Exclusion Criteria:

1. Recurrent tonsillitis as main symptoms leading to consideration for AT

2. Known genetic, cranio-facial or psychiatric condition likely to affect airway, cognition or behaviour

3. Obesity (Body Mass Index > 2.5 standard deviation from mean for age and gender)

4. Severe OSA (Apnoea Hypopnoea Index greater than 30 / hour on sleep study)

5. Severe chronic health conditions that may hamper participation. This may include severe congenital heart disease, cystic fibrosis, sickle cell anaemia, or poorly controlled epilepsy)

6. A history of significant hypertension (defined as greater than the 99th percentile (CDC prediction equations) plus 5mmHg for either systolic or diastolic.

7. Concurrent use of ADHD medicines, psychotropic medications (anti-depressants, anxiolytics, anti-psychotics), hypnotics or anti convulsants.

8. Previous adenotonsillectomy, tonsillectomy or adenoidectomy.

9. Receiving Continuous Positive Airway Pressure as a treatment

10. A parent or Guardian who is unable to read and thus understand the consent form.

11. A family planning to move out of the area within the next 9 months.

12. Severe snoring since birth.