Sleep Problems in Epileptic Children and Their Caregivers

• Conditions: Epileptic Children,Sleep Disturbances,Maladaptive Behaviors
• Interventions: Other: Children's sleep habits questionnaire (CSHQ)

• Registration Number: NCT05191576
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2022-01-02
• Study First Posted: 2022-01-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-26
• Last Update Posted: 2022-03-29
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
epileptic children	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	Children's sleep habits questionnaire (CSHQ)	healthy controls without any complaint (e.g., behavior problems, depression, or anxiety) that could interfere with sleep.

Primary Outcome Measures

Name	Time	Method
Sleep disturbances correlation with behavioral difficulties in epileptic children	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.

Trial Locations

Locations (1)

İpek Dokurel; 🇹🇷 İzmir, Other, Turkey