Royal Hospital for Sick Children
Edinburgh, EH9 1LF, United Kingdom
NCT Number: NCT03103841
Obstructive sleep apnoea (OSA) is a condition that affects around one in 20 children. In children with OSA, repeated episodes of airway obstruction can severely disturb and fragment sleep, leading to subsequent cognitive and behavioural problems .
Epilepsy affects 60,000 children in the UK and up to 30% of children with epilepsy have learning problems. Evidence suggests that OSA is more common in children with epilepsy, such that sleep disturbance could account for some of the learning problems they experience.
The aim of this study is to determine the prevalence of OSA in children with epilepsy. The investigators plan carry out detailed sleep studies in children with epilepsy and healthy controls to determine if children with epilepsy are more likely to have OSA than healthy children of the same age.
OSA is almost always treatable and the benefits of detecting and treating the condition in healthy children are well-established. If OSA proves to be a common finding in children with epilepsy, it will be important to carry out further studies to see if treating the condition has beneficial effects on learning and behaviour. This project could lead doctors to target sleep-disordered breathing as a way of improving learning outcomes in children with epilepsy.
Looking for future studies?
Notify Me5 year–18 year
All sexes
Observational
Edinburgh, EH9 1LF, United Kingdom
Obstructive sleep apnoea (OSA) is a condition that affects around one in 20 children. In OSA, the muscles and soft tissues in the throat relax and collapse during sleep causing the upper airway to become blocked. Breathing is briefly interrupted, blood oxygen levels fall and this causes the child to wake and start breathing again. These episodes can happen many times a night causing severely disturbed sleep. Untreated OSA may leave children with daytime attention difficulties and problems with learning and behaviour. Epilepsy affects approximately 60,000 children in the UK and up to 30 per cent of these children have associated learning problems.
There is evidence, including pilot work undertaken by the study team to suggest that OSA is more common in children with epilepsy, in which case, sleep disturbance could account for some of the learning problems they experience. The aim of this study is to determine the prevalence of OSA in children with epilepsy.
The investigators plan to carry out detailed polysomnography sleep studies in 55 children with epilepsy and 28 healthy children (controls). These studies will measure the length and quality of sleep over one night spent at the hospital. Seizure activity during this period will be monitored by video recordings combined with electroencephalograms (EEG). Sleep-disordered will be assessed using a variety of tests to measure air-flow, lung expansion and blood oxygen levels. This study should help to determine if children with epilepsy are more likely to have OSA than healthy children of the same age. OSA is almost always treatable and the benefits of detecting and treating the condition in healthy children are well-established.
If OSA proves to be a common finding in children with epilepsy, it will be important to carry out further studies to see if treating the condition has beneficial effects on learning and behaviour. This project could lead doctors to target sleep-disordered breathing as a way of improving learning outcomes in children with epilepsy.
Children with epilepsy attending Royal Hospital for Children, Edinburgh will be invited to take part in the study. Children without epilepsy (controls) will also be recruited. The children without epilepsy are included because although there are statistics for incidence of OSA in the general population, information for all the measures of sleep the team will collect are not available.
The study will assess sleep time, sleep efficiency, sleep architecture and respiratory events in children with epilepsy and control subjects.
To be sufficiently powered, it is planned to test 50 children with epilepsy and 25 healthy controls.
A sleep physiologist will work with participants to measure:
A neurologist and physiologist will assess seizure frequency and discharges between seizures, and epilepsy types using video EEG monitoring. Further information will be collected: height, weight, body mass index, antiepileptic medication use, tonsillar size, Mallampati score (a measure of base of tongue to hard palate), completion of sleep questionnaires by participants and their parents, to include sleepiness scales and sleep quality index.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undertaking of sleep measurements by polysomnography and use of validated sleep questionnaires
Time frame: Over study duration - 2 years
Measurement of presence and severity of obstructive sleep apnoea
Time frame: Over study duration - 2 years
As measured on sleep study
Time frame: Over study duration - 2 years
Used to quantify sleep fragmentation i.e. %time asleep out of total study time
Time frame: Up to 10 hours
Pittsburgh Sleep Quality Index questionnaire
Time frame: Over study duration - 2 years
PSQ-SRBD scale questionnaire
Time frame: Over study duration - 2 years
Epworth Sleepiness Score questionnaire
Time frame: Single point in time measurement - Sleep study [8 to 10 hour period of sleep data]
As measured on sleep EEG
NHS Lothian
Other Gov
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00047463
Apnea, Brain Diseases
Ann Arbor, Michigan, United States
View Trial DetailsNCT06352372
Autism Spectrum Disorder, Autistic Disorder
Phoenix, Arizona, United States
View Trial DetailsNCT06546410
Brain Diseases, Central Nervous System Diseases
Liverpool, United Kingdom
View Trial DetailsNCT07689084
Brain Diseases, Central Nervous System Diseases
Marburg, Hesse, Germany
View Trial Details