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

NCT02945306 | Completed

• 1 other identifier: 2016048
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Sleep Disordered Breathing

Keywords

Sleep Disordered Breathing; Adenotonsillectomy; Child

Outcome Measures

Primary Outcomes (1)

• Cognition

  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.

  8 months

Study Arms (2)

Adenotonsillectomy

EXPERIMENTAL

Removal of tonsils and adenoids under a general anaesthetic

Procedure: Adenotonsillectomy

Watchful waiting with supportive care

ACTIVE COMPARATOR

Reassurance with active medical treatment of conditions associated with Sleep Disordered Breathing such as otitis media with effusion and allergic rhinitis

Drug: Watchful waiting with supportive care

Interventions

Adenotonsillectomy PROCEDURE

Adenotonsillectomy

Watchful waiting with supportive care DRUG

Use of widely prescribed medicines to treat associated conditions

Watchful waiting with supportive care

Eligibility Criteria

• Age: 30 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Tees Hospitals NHS Foundation Trust: lead
• University of Leeds: collaborator

Study Sites (1)

The James Cook University Hospital

Middlesbrough, Cleveland, TS4 3BW, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Watchful Waiting; Palliative Care

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Michael R Tremlett, BM, FRCA

  South Tees Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: October 26, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)