Sleep Problems in Epileptic Children and Their Caregivers

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.

Study Overview

• Status: Recruiting
• Conditions: Epileptic Children,Sleep Disturbances,Maladaptive Behaviors
• Intervention / Treatment: Other: Children's sleep habits questionnaire (CSHQ)

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: İpek Dokurel, MD; Phone Number: +905325863157; Email: dripekdokurel@gmail.com
• Study Contact Backup: Name: İpek Dokurel; Phone Number: +905325863157; Email: dripekdokurel@gmail.com

Study Locations

• Turkey
  • Other
    • İzmir, Other, Turkey, 35100
      • Completed
      • İpek Dokurel
    • İzmir, Other, Turkey, 35100
      • Recruiting
      • İpek Dokurel
      • Contact: İpek Dokurel; Phone Number: +905325863157; Email: dripekdokurel@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Children's sleep habits questionnaire (CSHQ); 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.; Other Names: 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
healthy controls; healthy controls without any complaint (e.g., behavior problems, depression, or anxiety) that could interfere with sleep.	Other: Children's sleep habits questionnaire (CSHQ); 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.; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	participant would be assessed at the beginning of the study

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: January 2, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 26, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Epilepsy; Children; Caregiver; Sleep disturbances; SDQ; CSHQ
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Epilepsy; Dyssomnias; Parasomnias
• Other Study ID Numbers: E.148753

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: individual deidentified participant data (including data dictionaries) will be not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No