EpilepsyNCT03103841
Investigation of Sleep Quality and Prevalence of Sleep-disordered Breathing in Children and Young People With Epilepsy
An observational study of Epilepsy and Obstructive Sleep Apnea, run by NHS Lothian at 1 site in United Kingdom.
Trial 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 . Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Obstructive Sleep Apnea
- What is being tested?
- Sleep studies [Polysomnography]
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Mar 2017to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with epilepsy
Who may be able to join
- Diagnosis of primary epilepsy and attendance at Epilepsy clinic
Who cannot join
- Neurological co-morbidity affecting muscle tone OR any Respiratory co-morbidity including any history of asthma, airborne allergy or sleep-disordered breathing.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hospital for Sick Children
Edinburgh, EH9 1LF
About this study
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.
Read more
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.
Read the detailed description
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:
- Polysomnography (to record body functions in sleep - airflow in and out of the lungs, oxygen level in the blood, body position, breathing effort and rate, electrical activity of muscles, eye movement and heart rate)
- EEG or electroencephalography (to measure the electrical activity of the brain),
- Electrooculography (to measure rapid eye movements along horizontal and vertical axes),
- Chin electromyogram (to measure electrical impulses to chin muscles),
- Sleep quality.
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.
- Conditions
- Epilepsy, Obstructive Sleep Apnea
- Being tested
- Sleep studies [Polysomnography]
- Keywords
- Children
- Medical subject headings
- Epilepsy, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep studies [Polysomnography]Procedure or surgery
Undertaking of sleep measurements by polysomnography and use of validated sleep questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Sleep studies [Polysomnography] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/Hypopnea index
Measurement of presence and severity of obstructive sleep apnoea
Measured: Over study duration - 2 years
Secondary outcomes (5)
Total Sleep Time
As measured on sleep study
Measured: Over study duration - 2 years
Sleep Efficiency
Used to quantify sleep fragmentation i.e. %time asleep out of total study time
Measured: Over study duration - 2 years
Sleep Quality
Pittsburgh Sleep Quality Index questionnaire
Measured: Up to 10 hours
Symptoms of OSA
PSQ-SRBD scale questionnaire
Measured: Over study duration - 2 years
Daytime Sleepiness
Epworth Sleepiness Score questionnaire
Measured: Over study duration - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start31 Mar 2017
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Collaborators
- Action Medical Research, University of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Don S Urquhart, MD, FRCPCH, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103841
- Sponsor's protocol ID
- GN2392
- Status last verified
- Apr 2022
- First submitted
- 12 Dec 2016
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32351204Urquhart 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.
PubMed 38318844
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Sleep Quality and Prevalence of Sleep-disordered Breathing in Children and Young People With Epilepsy
- ClinicalTrials.gov ID
- NCT03103841
- Acronym / sponsor ID
- GN2392
- Conditions
- Epilepsy, Obstructive Sleep Apnea
- Keywords
- Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Collaborators
- Action Medical Research, University of Edinburgh
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Polysomnography (to record body functions in sleep - airflow in and out of the lungs, oxygen level in the blood, body position, breathing effort and rate, electrical activity of muscles, eye movement and heart rate)
- EEG or electroencephalography (to measure the electrical activity of the brain),
- Electrooculography (to measure rapid eye movements along horizontal and vertical axes),
- Chin electromyogram (to measure electrical impulses to chin muscles),
- Sleep quality.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children and young people with epilepsy | – | Procedure: Sleep studies [Polysomnography]Sleep studies [Polysomnography] to assess presence and severity of obstructive sleep apnoea in children with epilepsy compared with a healthy control group |
| Healthy controls | – | Procedure: Sleep studies [Polysomnography]Sleep studies [Polysomnography] to assess presence and severity of obstructive sleep apnoea in children with epilepsy compared with a healthy control group |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with epilepsy
Key inclusion criteria (1 listed)
- Diagnosis of primary epilepsy and attendance at Epilepsy clinic
Key exclusion criteria (1 listed)
- Neurological co-morbidity affecting muscle tone OR any Respiratory co-morbidity including any history of asthma, airborne allergy or sleep-disordered breathing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep studies [Polysomnography]Undertaking of sleep measurements by polysomnography and use of validated sleep questionnaires | Procedure or surgery | Children and young people with epilepsy, Healthy controls |
Primary outcome
Apnea/Hypopnea index
Time frame: Over study duration - 2 years
Measurement of presence and severity of obstructive sleep apnoea
5 secondary outcomes
Total Sleep Time
Time frame: Over study duration - 2 years
Sleep Efficiency
Time frame: Over study duration - 2 years
Sleep Quality
Time frame: Up to 10 hours
Symptoms of OSA
Time frame: Over study duration - 2 years
Daytime Sleepiness
Time frame: Over study duration - 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Results publication: PubMed 32351204Urquhart 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.
- Derived from this study: PubMed 38318844Urquhart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don S Urquhart, MD, FRCPCH principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Obstructive Sleep Apnea, run by NHS Lothian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea/Hypopnea index (time frame: Over study duration - 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03103841, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.