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临床试验 NCT07168577 (CP-SLEEP) 针对脑瘫，儿童睡眠障碍，护理人员负担，睡眠质量，Anxiety and Depression (Caregivers)目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Sleep Quality and Caregiver Burden in Children With Cerebral Palsy (CP-SLEEP) 200
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临床试验NCT07168577 (CP-SLEEP)是一项针对脑瘫，儿童睡眠障碍，护理人员负担，睡眠质量，Anxiety and Depression (Caregivers)的观察研究试验，目前试验状态为招募中。试验始于2025年9月8日，计划招募200名患者。该研究由Selim Sezikli主导，预计于2026年3月8日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月24日。
简要概括
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 aim...
显示更多详细描述
Cerebral palsy (CP) is the most common cause of motor disability in childhood and often requires long-term daily care provided by family members. Sleep disorders are highly prevalent in children with CP compared with typically developing peers and are frequently associated with spasticity, seizures, pain, and behavioral issues. Poor sleep may further compromise the child's functional capacity and quality of life. At ...显示更多
官方标题
Evaluation of Sleep Quality and Caregiver Burden in Children With Cerebral Palsy
疾病
脑瘫儿童睡眠障碍护理人员负担睡眠质量Anxiety and Depression (Caregivers)其他研究标识符
- CP-SLEEP
- CP-2025-01
NCT编号
实际开始日期
2025-09-08
最近更新发布
2026-02-24
预计完成日期
2026-03-08
计划入组人数
200
研究类型
观察研究
试验状态
招募中
关键词
Zarit Burden Interview (ZBI)
Children's Sleep Habits Questionnaire (CSHQ)
Cerebral palsy
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Sleep disorders
Caregiver burden
Caregiver sleep quality
Children's Sleep Habits Questionnaire (CSHQ)
Cerebral palsy
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Sleep disorders
Caregiver burden
Caregiver sleep quality
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Children With Cerebral Palsy and Primary Caregivers This cohort includes children aged 2-18 years with a confirmed diagnosis of cerebral palsy and their primary caregivers (parents or legal guardians aged ≥18 years). All participants will undergo standardized clinical and questionnaire-based assessments. For children, sleep quality will be evaluated with the Children's Sleep Habits Questionnaire (CSHQ), and functional status will be classified using GMFCS, MACS, and C...显示更多 | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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. | 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. | 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. | Day 1 (single assessment at baseline) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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. | 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. | 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. | 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. | 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. | Day 1 (single assessment at baseline) |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
最低年龄要求
2 Years
适龄性别
全部
- 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
- 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
Selim Sezikli研究责任方
Selim Sezikli, 申办者-研究者, Medical Doctor, Specialist in Physical Medicine and Rehabilitation, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
研究中心联系人
联系人: Selim Sezikli, MD, +90 506 510 18 33, [email protected]
联系人: Cansın Medin Ceylan, Assoc. Prof., +90 531 575 95 39, [email protected]
1 位于 1 个国家/地区的研究中心
Istanbul Physical Medicine and Rehabilitation Training and research Hospital, Istanbul, Turkey (Türkiye)
Selim Sezikli, MD, 联系人, +902124965000, [email protected]
Cansın Medin Ceylan, Assoc. Prof., 联系人, +90 531 575 95 39, [email protected]
Selim Sezikli, MD, 主要研究者
Cansın Medin Ceylan, Assoc. Prof., 分研究者
Fatma Nur Kesiktas, Prof., 分研究者
Merve Damla Korkmaz, Assoc. Prof., 分研究者
Yelda Soluk Ozdemir, MD, 分研究者
Nurdan Paker, Prof., 分研究者
招募中