Clinical trial NCT05191576: Sleep Problems in Epileptic Children and Their Caregivers
Official title: Sleep Problems in Epileptic Children and Their Caregivers: Associations With Psychometric
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epileptic Children,Sleep Disturbances,Maladaptive Behaviors
Keywords: Children
Epilepsy
CSHQ
SDQ
Caregiver
Sleep disturbances
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 120
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Sleep disturbances correlation with behavioral difficulties in epileptic children
timeFrame: participant would be assessed at the beginning of the study
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İpek Dokurel
state: Other
city: İzmir
country: Turkey
facility: İpek Dokurel
state: Other
Study officials:
References: