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Trial record 3 of 16 for:    Recruiting Studies | Epilepsy | United Kingdom

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

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ClinicalTrials.gov Identifier: NCT03103841
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Collaborators:
Action Medical Research
University of Edinburgh
Information provided by (Responsible Party):
NHS Lothian

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.


Condition or disease Intervention/treatment
Epilepsy Obstructive Sleep Apnea Procedure: Sleep studies [Polysomnography]

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 83 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Investigation of Sleep Quality and Prevalence of Sleep-disordered Breathing in Children and Young People With Epilepsy
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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]
Undertaking of sleep measurements by polysomnography and use of validated sleep questionnaires

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




Primary Outcome Measures :
  1. Apnea/Hypopnea index [ Time Frame: Over study duration - 2 years ]
    Measurement of presence and severity of obstructive sleep apnoea


Secondary Outcome Measures :
  1. Total Sleep Time [ Time Frame: Over study duration - 2 years ]
    As measured on sleep study

  2. Sleep Efficiency [ Time Frame: Over study duration - 2 years ]
    Used to quantify sleep fragmentation i.e. %time asleep out of total study time

  3. Sleep Quality [ Time Frame: Up to 10 hours ]
    Pittsburgh Sleep Quality Index questionnaire

  4. Symptoms of OSA [ Time Frame: Over study duration - 2 years ]
    PSQ-SRBD scale questionnaire

  5. Daytime Sleepiness [ Time Frame: Over study duration - 2 years ]
    Epworth Sleepiness Score questionnaire


Other Outcome Measures:
  1. Presence of epileptiform discharges during sleep [ Time Frame: Single point in time measurement - Sleep study [8 to 10 hour period of sleep data] ]
    As measured on sleep EEG



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with epilepsy
Criteria

Inclusion Criteria:

  • Diagnosis of primary epilepsy and attendance at Epilepsy clinic

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103841


Contacts
Contact: Don S Urquhart, MD, FRCPCH don.urquhart@nhslothian.scot.nhs.uk

Locations
United Kingdom
Royal Hospital for Sick Children Recruiting
Edinburgh, United Kingdom, EH9 1LF
Contact: Don S Urquhart, MD, FRCPCH       don.urquhart@nhslothian.scot.nhs.uk   
Sponsors and Collaborators
NHS Lothian
Action Medical Research
University of Edinburgh
Investigators
Principal Investigator: Don S Urquhart, MD, FRCPCH NHS Lothian

Publications of Results:
Responsible Party: NHS Lothian
ClinicalTrials.gov Identifier: NCT03103841     History of Changes
Other Study ID Numbers: GN2392
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by NHS Lothian:
Children

Additional relevant MeSH terms:
Epilepsy
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiratory Aspiration
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Pathologic Processes