Sleep Problems in Epileptic Children and Their Caregivers

NCT ID: NCT05191576

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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The aim of this study is to investigate the frequency of sleep problems in epileptic children and their caregivers.

Detailed Description

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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.

Conditions

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Epileptic Children,Sleep Disturbances,Maladaptive Behaviors

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Children's sleep habits questionnaire (CSHQ)

Intervention Type OTHER

1. 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.

healthy controls

healthy controls without any complaint (e.g., behavior problems, depression, or anxiety) that could interfere with sleep.

Children's sleep habits questionnaire (CSHQ)

Intervention Type OTHER

1. 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.

Interventions

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Children's sleep habits questionnaire (CSHQ)

1. 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.

Intervention Type OTHER

Other Intervention Names

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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

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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İpek Dokurel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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İpek Dokurel

Izmir, Other, Turkey (Türkiye)

Site Status COMPLETED

İpek Dokurel

Izmir, Other, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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İpek Dokurel, MD

Role: CONTACT

+905325863157

İpek Dokurel

Role: CONTACT

+905325863157

Facility Contacts

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İpek Dokurel

Role: primary

+905325863157

Other Identifiers

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E.148753

Identifier Type: -

Identifier Source: org_study_id

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