Investigation of Sleep Quality and Prevalence of Sleep-disordered Breathing in Children and Young People With Epilepsy

NCT03103841 | Completed

• 1 other identifier: GN2392
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy; Obstructive Sleep Apnea

Keywords

Children

Outcome Measures

Primary Outcomes (1)

• Apnea/Hypopnea index

  Measurement of presence and severity of obstructive sleep apnoea

  Over study duration - 2 years

Secondary Outcomes (5)

• Total Sleep Time

  Over study duration - 2 years

• Sleep Efficiency

  Over study duration - 2 years

• Sleep Quality

  Up to 10 hours

• Symptoms of OSA

  Over study duration - 2 years

• Daytime Sleepiness

  Over study duration - 2 years

Other Outcomes (1)

• Presence of epileptiform discharges during sleep

  Single point in time measurement - Sleep study [8 to 10 hour period of sleep data]

Study Arms (2)

Children and young people with epilepsy

Sleep studies \[Polysomnography\] to assess presence and severity of obstructive sleep apnoea in children with epilepsy compared with a healthy control group

Procedure: Sleep studies [Polysomnography]

Healthy controls

Sleep studies \[Polysomnography\] to assess presence and severity of obstructive sleep apnoea in children with epilepsy compared with a healthy control group

Procedure: Sleep studies [Polysomnography]

Interventions

Sleep studies [Polysomnography] PROCEDURE

Undertaking of sleep measurements by polysomnography and use of validated sleep questionnaires

Children and young people with epilepsy; Healthy controls

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with epilepsy

You may qualify if:

• Diagnosis of primary epilepsy and attendance at Epilepsy clinic

You may not qualify if:

• Neurological co-morbidity affecting muscle tone OR any Respiratory co-morbidity including any history of asthma, airborne allergy or sleep-disordered breathing.

Sponsors & Collaborators

• NHS Lothian: lead
• Action Medical Research: collaborator
• University of Edinburgh: collaborator

Study Sites (1)

Royal Hospital for Sick Children

Edinburgh, EH9 1LF, United Kingdom

Location

Related Publications (2)

• Urquhart DS, Hill EA, Hill LE, Carruthers E, McLellan AE, Chin R, Shetty J. Adults with epilepsy appear to differ from children in regard to daytime sleepiness. J Clin Sleep Med. 2020 Aug 15;16(8):1393-1394. doi: 10.5664/jcsm.8528.

  PMID: 32351204 RESULT

• Urquhart DS, McLellan AE, Hill LE, Carruthers E, Hill EA, Chin RF, Shetty J. A case-control study to investigate the prevalence of obstructive sleep apnea and the utility of the Sleep-Related Breathing Disorder scale of the Pediatric Sleep Questionnaire in children and young people with epilepsy. J Clin Sleep Med. 2024 Jul 1;20(7):1039-1047. doi: 10.5664/jcsm.11054.

  PMID: 38318844 DERIVED

MeSH Terms

Conditions

Epilepsy; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Don S Urquhart, MD, FRCPCH

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: April 6, 2017
• Study Start: March 31, 2017
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 28, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)