NCT07168577 Sleep Quality and Caregiver Burden in Children With Cerebral Palsy
| NCT ID | NCT07168577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Selim Sezikli |
| Condition | Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-09-08 |
| Primary Completion | 2026-03-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-09-08 with a primary completion date of 2026-03-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Children aged 2-18 years with a confirmed diagnosis of cerebral palsy * Primary caregiver (≥18 years, parent or legal guardian) responsible for the child's daily care * Ability to read and write in Turkish * Sufficient cognitive capacity to complete questionnaires and participate in interviews * Voluntary agreement of both the child's caregiver and participant to join the study Exclusion Criteria: * Presence of severe comorbid neurological or metabolic disease in the child * Caregiver with a history of severe psychiatric disorder or cognitive impairment * Communication problems that prevent completion of questionnaires * Hospitalization within the last 3 months due to acute medical condition * Withdrawal of consent or incomplete questionnaires during the study
Contact & Investigator
Selim Sezikli, MD
PRINCIPAL INVESTIGATOR
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Frequently Asked Questions
Who can join the NCT07168577 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07168577 currently recruiting?
Yes, NCT07168577 is actively recruiting participants. Contact the research team at selimsezikli@hotmail.com for enrollment information.
Where is the NCT07168577 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07168577 clinical trial?
NCT07168577 is sponsored by Selim Sezikli. The principal investigator is Selim Sezikli, MD at Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. The trial plans to enroll 200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.