Epileptic Children,Sleep Disturbances,Maladaptive BehaviorsNCT05191576
Sleep Problems in Epileptic Children and Their Caregivers
An observational study of Epileptic Children,Sleep Disturbances,Maladaptive Behaviors, run by Ege University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the frequency of sleep problems in epileptic children and their caregivers. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Epileptic Children,Sleep Disturbances,Maladaptive Behaviors
- What is being tested?
- Children's sleep habits questionnaire (CSHQ)
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 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 11 to 18 years
- All sexes
- Child, Adult
Study population: A total of 120 patients (epileptic patients: 50, healthy controls: 70) aged 11-17 years who were attended to the pediatric neurology outpatient clinic of Ege University Medical Faculty between February and June 2020 were recruited to this observational case-control study. In the patient group, 13 patients were excluded due to incomplete questionnaires and the following exclusion criteria. In the control group, 23 children with incomplete forms and 4 children with presence of depressive or an anxiety disorder were excludedThe study cohort consisted of 80 cases. 37 were epileptic patients as study group and 43 were similar aged healthy children as control group. The control group was matched in terms of their age, gender, and caregiver educational level
Who may be able to join
- clinical diagnosis of epilepsy that based on the International League Against Epilepsy (ILAE) operational clinical definition criteria for epilepsy
- must be diagnosed by pediatric neurologists
- must receive treatment for at least one year.
Who cannot join
- to have an IQ ≤80, as measured by the Wechsler Intelligence Scale for Children-Revised Form (WISC-R) or below-average academic performance documented by last year's final school grade
- to have a history of psychiatric, developmental disorder, or psychosis
- to have a history of progressive neurological disorder other than epilepsy
- to have any complaint (e.g., behavior problems, depression, or anxiety) that could interfere with sleep
- to have a caregiver who has any medical or psychiatric condition (e.g., depression or anxiety) that could interfere with sleep.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 1 recruiting
- Completed
İpek Dokurel
Izmir, Other, 35100
- Recruiting
İpek Dokurel
Izmir, Other, 35100
İpek Dokurel, +905325863157, dripekdokurel@gmail.com
About this study
Official title: Sleep Problems in Epileptic Children and Their Caregivers: Associations With Psychometric
The aim of this study is to investigate the frequency of sleep problems in epileptic children and their caregivers.
Read the detailed description
The study instruments include two parts. First, data on socio-demographic, height, weight, the sleep duration, caregiver's level of education (Illiterate, Preliminary school, High school, University), caregiver sleep problems, and medical background were noted. Clinical data regarding epilepsy (a type of seizure, etiology, the frequency of seizures, actual and previous antiseizure medications) were collected from interviews of participants/parents and examination. Second, the psychometric assessment tools used to evaluate all participants and caregivers; Children's sleep habits questionnaire (CSHQ), strength and difficulties questionnaire (SDQ), diagnostic and statistical manual of mental disorders (DSM)-V Sleep Disorders Scale-Child Report, DSM-V Sleep Disorder Scale- Adult Report. All participants and their caregivers completed the psychometric questionnaires.
- Being tested
- Children's sleep habits questionnaire (CSHQ)
- Keywords
- Children, Epilepsy, CSHQ, SDQ, Caregiver, Sleep disturbances
- Medical subject headings
- Epilepsy, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children's sleep habits questionnaire (CSHQ)Other
Also called Strength and difficulties questionnaire (SDQ), Diagnostic and statistical manual of mental disorders (DSM)-V Sleep Disorders Scale-Child Report, DSM-V Sleep Disorder Scale- Adult Report
- Children's Sleep Habits Questionnaire is a validated tool to screen sleep behavior in young children's assessment of pediatric sleep problems.
- DSM-V Level II Sleep Disturbance- Child Report. is retrospective, 8-item self-report used to assess the pure domain of sleep disturbances in children and adolescents age of 11-17 years in the past seven days.Higher scores indicate more severe sleep disorders. High scores on a particular domain might indicate significant and problematic areas for the child that may warrant further assessment.
- DSM -V Sleep Disturbance -Adult Report. is used to assess the pure domain of sleep disturbances in adults for the past seven days. SDQ).is used to screen emotional and behavioral problems in children.
- SDQ is used to screen emotional and behavioral problems in children.
| Study group | Role | What they receive |
|---|---|---|
| epileptic children | All patients were diagnosed based on the International League Against Epilepsy (ILAE) operational clinical definition criteria for epilepsy and pediatric neurologists made the diagnosis. The patients had been receiving treatment for at least one year. Epileptic patients were grouped into idiopathic generalized or self-limiting focal epilepsy syndromes according to the International League Against Epilepsy (ILAE) criteria for epileptic seizures and syndromes and guidelines for epidemiological studies for diagnosis and classification. Receives: Other: Children's sleep habits questionnaire (CSHQ) | |
| healthy controls | healthy controls without any complaint (e.g., behavior problems, depression, or anxiety) that could interfere with sleep. Receives: Other: Children's sleep habits questionnaire (CSHQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep disturbances correlation with behavioral difficulties in epileptic children
The subscales of sleep problems would be investigated with Diagnostic and Statistical Manual of Mental Disorders (DSM) -V Level II Sleep Disturbance- Child Report,Children's Sleep Habits Questionnaire. The subscales of behavioral problems in epileptic children would be investigated with Strength and Difficulties Questionnaire.The correlation of these subscales would be correlated with statistical methods to define significant differences.
Measured: participant would be assessed at the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epileptic Children,Sleep Disturbances,Maladaptive BehaviorsStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İpek Dokurel, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191576
- Sponsor's protocol ID
- E.148753
- Status last verified
- Mar 2022
- First submitted
- 28 Dec 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: individual deidentified participant data (including data dictionaries) will be not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Problems in Epileptic Children and Their Caregivers: Associations With Psychometric
- ClinicalTrials.gov ID
- NCT05191576
- Acronym / sponsor ID
- E.148753
- Keywords
- Children, Epilepsy, CSHQ, SDQ, Caregiver, Sleep disturbances
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Jan 2022 (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.
The aim of this study is to investigate the frequency of sleep problems in epileptic children and their caregivers.
Detailed description
The study instruments include two parts. First, data on socio-demographic, height, weight, the sleep duration, caregiver's level of education (Illiterate, Preliminary school, High school, University), caregiver sleep problems, and medical background were noted. Clinical data regarding epilepsy (a type of seizure, etiology, the frequency of seizures, actual and previous antiseizure medications) were collected from interviews of participants/parents and examination. Second, the psychometric assessment tools used to evaluate all participants and caregivers; Children's sleep habits questionnaire (CSHQ), strength and difficulties questionnaire (SDQ), diagnostic and statistical manual of mental disorders (DSM)-V Sleep Disorders Scale-Child Report, DSM-V Sleep Disorder Scale- Adult Report. All participants and their caregivers completed the psychometric questionnaires.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epileptic children | – | Other: Children's sleep habits questionnaire (CSHQ)All patients were diagnosed based on the International League Against Epilepsy (ILAE) operational clinical definition criteria for epilepsy and pediatric neurologists made the diagnosis. The patients had been receiving treatment for at least one year. Epileptic patients were grouped into idiopathic generalized or self-limiting focal epilepsy syndromes according to the International League Against Epilepsy (ILAE) criteria for epileptic seizures and syndromes and guidelines for epidemiological studies for diagnosis and classification. |
| healthy controls | – | Other: Children's sleep habits questionnaire (CSHQ)healthy controls without any complaint (e.g., behavior problems, depression, or anxiety) that could interfere with sleep. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- A total of 120 patients (epileptic patients: 50, healthy controls: 70) aged 11-17 years who were attended to the pediatric neurology outpatient clinic of Ege University Medical Faculty between February and June 2020 were recruited to this observational case-control study. In the patient group, 13 patients were excluded due to incomplete questionnaires and the following exclusion criteria. In the control group, 23 children with incomplete forms and 4 children with presence of depressive or an anxiety disorder were excludedThe study cohort consisted of 80 cases. 37 were epileptic patients as study group and 43 were similar aged healthy children as control group. The control group was matched in terms of their age, gender, and caregiver educational level
Key inclusion criteria (3 listed)
- clinical diagnosis of epilepsy that based on the International League Against Epilepsy (ILAE) operational clinical definition criteria for epilepsy
- must be diagnosed by pediatric neurologists
- must receive treatment for at least one year.
Key exclusion criteria (5 listed)
- to have an IQ ≤80, as measured by the Wechsler Intelligence Scale for Children-Revised Form (WISC-R) or below-average academic performance documented by last year's final school grade
- to have a history of psychiatric, developmental disorder, or psychosis
- to have a history of progressive neurological disorder other than epilepsy
- to have any complaint (e.g., behavior problems, depression, or anxiety) that could interfere with sleep
- to have a caregiver who has any medical or psychiatric condition (e.g., depression or anxiety) that could interfere with sleep.
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 |
|---|---|---|
| Children's sleep habits questionnaire (CSHQ)Also: Strength and difficulties questionnaire (SDQ), Diagnostic and statistical manual of mental disorders (DSM)-V Sleep Disorders Scale-Child Report, DSM-V Sleep Disorder Scale- Adult Report1. Children's Sleep Habits Questionnaire is a validated tool to screen sleep behavior in young children's assessment of pediatric sleep problems. 2. DSM-V Level II Sleep Disturbance- Child Report. is retrospective, 8-item self-report used to assess the pure domain of sleep disturbances in children and adolescents age of 11-17 years in the past seven days.Higher scores indicate more severe sleep disorders. High scores on a particular domain might indicate significant and problematic areas for the child that may warrant further assessment. 3. DSM -V Sleep Disturbance -Adult Report. is used to assess the pure domain of sleep disturbances in adults for the past seven days. SDQ).is used to screen emotional and behavioral problems in children. 4. SDQ is used to screen emotional and behavioral problems in children. | Other | epileptic children, healthy controls |
Primary outcome
Sleep disturbances correlation with behavioral difficulties in epileptic children
Time frame: participant would be assessed at the beginning of the study
The subscales of sleep problems would be investigated with Diagnostic and Statistical Manual of Mental Disorders (DSM) -V Level II Sleep Disturbance- Child Report,Children's Sleep Habits Questionnaire. The subscales of behavioral problems in epileptic children would be investigated with Strength and Difficulties Questionnaire.The correlation of these subscales would be correlated with statistical methods to define significant differences.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Undecided. individual deidentified participant data (including data dictionaries) will be not be shared.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epileptic Children,Sleep Disturbances,Maladaptive Behaviors, run by Ege University at 2 sites in Turkey (Türkiye).
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İpek Dokurel, MD (+905325863157, dripekdokurel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep disturbances correlation with behavioral difficulties in epileptic children (time frame: participant would be assessed at the beginning of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2022.