Clinical Trial

Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

Study acronym: CP-SLEEP
Completed
View on ClinicalTrials.gov →
Summary
Cerebral palsy (CP) is a lifelong condition that affects movement and posture in children, often requiring continuous care from family members. Children with CP frequently experience sleep problems due to spasticity, pain, seizures, or behavioral difficulties. Poor sleep can negatively affect the child's health and development, as well as increase the physical and emotional burden on their caregivers. This study aims to evaluate the sleep quality of children with CP and their primary caregivers, and to examine the relationship between caregiver burden and these sleep-related factors. The study will include children aged 2 to 18 years with a diagnosis of CP and their primary caregivers (parents or legal guardians). Children's sleep patterns will be assessed using the Children's Sleep Habits Questionnaire (CSHQ). Their functional levels will be classified using the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS). Caregivers' sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI), caregiver burden with the Zarit Burden Interview (ZBI), and psychological status with the Hospital Anxiety and Depression Scale (HADS). By identifying how sleep problems are linked with caregiver burden and psychological health, this study may provide valuable insights for developing supportive intervention programs for both children with CP and their families.
Protocol Amendment History 2 changes
critical Trial completed 2026-05-27
notable Enrollment reduced: 200 -> 62 participants 2026-05-27
Trial Details
NCT Number NCT07168577
Lead Sponsor Selim Sezikli
Conditions Cerebral Palsy, Sleep Disorders in Children, Caregiver Burden, Sleep Quality, Anxiety and Depression (Caregivers)
Enrollment 62 participants
Start Date 2025-09-08
Primary Completion 2026-03-08 (estimated)
Study Completion 2026-03-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-26