Cerebral PalsyCP-SLEEPNCT07168577
Sleep Quality and Caregiver Burden in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Sleep Disorders in Children, run by Selim Sezikli at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) is a lifelong condition affecting movement and posture, often requiring substantial care from family members. Children with CP frequently experience sleep disturbances associated with motor impairment, pain, seizures, and other clinical factors. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cerebral Palsy, Sleep Disorders in Children, Caregiver Burden
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jul 2025to 7 Jun 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of children aged 2-18 years diagnosed with cerebral palsy and their primary caregivers (parents or legal guardians aged ≥18 years). Participants will be recruited from the outpatient clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine and Rehabilitation Training and research Hospital
Istanbul
About this study
Official title: Evaluation of Sleep Quality and Caregiver Burden in Children With Cerebral Palsy
Cerebral palsy (CP) is a lifelong condition affecting movement and posture, often requiring substantial care from family members. Children with CP frequently experience sleep disturbances associated with motor impairment, pain, seizures, and other clinical factors. Sleep difficulties may also be associated with poor sleep quality, psychological symptoms, and increased burden among caregivers.
This single-center, observational, cross-sectional study evaluated sleep characteristics in children with CP, caregiver sleep quality, and caregiver burden, as well as their associations with functional status and caregiver psychological symptoms.
Read more
The study included 61 children with CP and their primary caregivers. Eligible children were aged 2-18 years. Children's sleep characteristics were assessed using a 33-item parent-reported questionnaire adapted from the Children's Sleep Habits Questionnaire (CSHQ), which was not identical to the validated Turkish CSHQ. Children's functional characteristics were evaluated using GMFCS, MACS, and CFCS. Caregiver sleep quality, caregiver burden, and psychological symptoms were assessed using the Pittsburgh Sleep Quality Index (PSQI), Zarit Burden Interview (ZBI), and Hospital Anxiety and Depression Scale (HADS), respectively.
The study was designed to examine associations among child sleep characteristics, caregiver sleep quality, caregiver burden, and psychological well-being.
Read the detailed description
Cerebral palsy (CP) is a common cause of motor disability in childhood and is frequently associated with long-term care needs. Sleep disturbances are common among children with CP and may coexist with motor impairment, epilepsy, pain, and behavioral difficulties. Caregivers may experience substantial physical and psychological demands, including sleep problems, anxiety, depressive symptoms, and caregiver burden.
This single-center, observational, cross-sectional study was conducted in the outpatient Physical Medicine and Rehabilitation clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Türkiye. The study initially planned to recruit at least 100 child-caregiver pairs. Data collection was completed with 61 children diagnosed with CP and their primary caregivers. Participants were recruited through convenience sampling and voluntary participation.
Children were eligible if they were aged 2-18 years with a diagnosis of CP and their adult primary caregivers were evaluated. Children's functional characteristics were classified using the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS). Spasticity was evaluated using the Modified Ashworth Scale.
Children's sleep characteristics were assessed using a 33-item parent-reported questionnaire adapted from the Children's Sleep Habits Questionnaire (CSHQ). The questionnaire administered in this study differed in item wording and scoring structure from the validated Turkish CSHQ; therefore, the resulting scores should not be considered directly equivalent to those obtained from the validated instrument.
Caregiver sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), caregiver burden using the Zarit Burden Interview (ZBI), and anxiety and depressive symptoms using the Hospital Anxiety and Depression Scale (HADS).
The study examined associations among children's sleep characteristics, functional status, caregiver sleep quality, caregiver burden, and psychological symptoms using descriptive and inferential statistical methods. Analyses involving the adapted child sleep questionnaire were interpreted as exploratory because of differences from the validated CSHQ instrument.
- Conditions
- Cerebral Palsy, Sleep Disorders in Children, Caregiver Burden, Sleep Quality, Anxiety and Depression (Caregivers)
- Keywords
- Zarit Burden Interview (ZBI), Cerebral palsy, Sleep quality, Pittsburgh Sleep Quality Index (PSQI), Sleep disorders, Caregiver burden, Caregiver sleep quality, Adapted Child Sleep Questionnaire
- Medical subject headings
- Cerebral Palsy, Caregiver Burden, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children With Cerebral Palsy and Primary Caregivers | This group comprised 61 children aged 2-18 years with cerebral palsy and their primary caregivers. Children underwent functional assessments using GMFCS, MACS, and CFCS, and spasticity assessment using the Modified Ashworth Scale. Children's sleep characteristics were evaluated using a 33-item questionnaire adapted from the CSHQ. Caregiver sleep quality, caregiver burden, and psychological symptoms were assessed using the PSQI, ZBI, and HADS, respectively. No experimental intervention was administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Sleep Quality Assessed by Children's Sleep Habits Questionnaire (CSHQ)
Sleep quality of children with cerebral palsy will be assessed using the parent-reported Children's Sleep Habits Questionnaire (CSHQ), a validated scale measuring common sleep behaviors and problems in children.
Measured: Day 1 (single assessment at baseline)
Caregiver Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
Sleep quality of caregivers will be measured using the Pittsburgh Sleep Quality Index (PSQI), which evaluates sleep patterns and disturbances over the previous month.
Measured: Day 1 (single assessment at baseline)
Caregiver Burden Assessed by Zarit Burden Interview (ZBI)
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a validated questionnaire evaluating the impact of caregiving on emotional, physical, and social well-being.
Measured: Day 1 (single assessment at baseline)
Secondary outcomes (5)
Child Functional Level Assessed by Gross Motor Function Classification System (GMFCS)
Functional motor levels of children with cerebral palsy will be classified according to the GMFCS, a standardized 5-level system describing gross motor function.
Measured: Day 1 (single assessment at baseline)
Manual Ability Assessed by Manual Ability Classification System (MACS)
Hand function and manual ability of children will be evaluated using the MACS, a validated classification system for children with cerebral palsy.
Measured: Day 1 (single assessment at baseline)
Communication Function Assessed by Communication Function Classification System (CFCS)
Communication ability of children will be assessed using the CFCS, which categorizes functional communication performance in daily life.
Measured: Day 1 (single assessment at baseline)
Spasticity Assessed by Modified Ashworth Scale (MAS)
Muscle spasticity will be measured using the Modified Ashworth Scale (MAS), a widely used clinical tool for grading resistance to passive movement.
Measured: Day 1 (single assessment at baseline)
Caregiver Psychological Status Assessed by Hospital Anxiety and Depression Scale (HADS)
Caregivers' psychological health will be evaluated using the HADS, a self-reported screening tool for symptoms of anxiety and depression.
Measured: Day 1 (single assessment at baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start9 Jul 2025
- Primary completion7 Jun 2026
- Study completion7 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selim Sezikli
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Selim Sezikli, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Selim Sezikli, MD, Principal investigator, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168577
- Sponsor's protocol ID
- CP-2025-01
- Acronym
- CP-SLEEP
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared, including demographic information, child sleep quality scores (CSHQ), functional classification levels (GMFCS, MACS, CFCS), spasticity scores (MAS), caregiver sleep quality (PSQI), caregiver burden (ZBI), and psychological status (HADS). Data will be anonymized and shared in compliance with ethical and confidentiality requirements.