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Clinical Trials/NCT05191576
NCT05191576
Unknown
Not Applicable

Sleep Problems in Epileptic Children and Their Caregivers: Associations With Psychometric

Ege University1 site in 1 country120 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epileptic Children,Sleep Disturbances,Maladaptive Behaviors
Sponsor
Ege University
Enrollment
120
Locations
1
Primary Endpoint
Sleep disturbances correlation with behavioral difficulties in epileptic children
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

İpek Dokurel

Principal Investigator

Ege University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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