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RecruitingNCT07122921

Cross-sectional Study of Sleep Disturbance in Hong Kong Children With Cancer Comparing With Healthy Counterparts and Children With Other Chronic Diseases

Sleep Disturbance in Hong Kong Children With Cancer: A Cross-Sectional Study Comparing Healthy Counterparts and Children With Other Chronic Diseases

Status
Recruiting
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Chinese University of Hong Kong · Academic / Other
Sex
All
Age
6 Years – 18 Years
Healthy volunteers
Accepted

Summary

Sleep disturbances are prevalent among children with chronic illnesses, yet the specific impact of cancer on sleep remains underexplored. This prospective and cross-sectional study aims to evaluate the prevalence, severity, and characteristics of sleep disturbances in Chinese children with cancer compared to healthy peers and children with other chronic diseases. By leveraging validated sleep assessment tools and parental reports, the goal is to identify unique challenges faced by children with cancer. Results might influence the design of personalized interventions aimed at enhancing the overall well-being of children with cancer. This study will enroll Chinese children aged 6 to 18 years, divided into three distinct groups based on their health status: children with cancer, children with other chronic illnesses, and healthy children. A total sample size of 150 participants (50 per group) will be targeted to ensure adequate statistical power for comparative analyses. Recruitment will occur at Hong Kong Children's Hospital or the cancer and chronic illness groups, and healthy children will be recruited from healthy siblings of participants or the healthy children of hospital staff with specific inclusion and exclusion criteria applied to each group to maintain homogeneity and minimize confounding variables.

Detailed description

The objectives of this study are threefold: 1. To assess the prevalence and nature of sleep disturbances in children with cancer. 2. To compare sleep disturbances in children with cancer to those in healthy children and children with other chronic diseases. 3. To identify potential factors contributing to sleep disturbances in paediatric patients. Sleep quality, measured by the global PSQI score, will be the primary endpoint. This encompasses the seven component scores (e.g., sleep duration, latency, efficiency), providing a holistic assessment of sleep health. A global score \>5 will classify participants as having poor sleep quality, enabling prevalence comparisons across groups. Health-related quality of life, assessed via the PedsQL total score and its domain-specific subscales (physical, emotional, social, school), as well as physical health summary score and psychosocial health summary score will examine the broader impact of sleep disturbances. This will help determine, for example, whether poor sleep in children with cancer correlates with reduced emotional or physical functioning compared to other groups. To control for potential confounding effects on sleep patterns and access to healthcare resources, the following demographic and clinical variables will be collected: age (in years), gender, socioeconomic status (SES), disease type, disease status, and use of hypnotics (yes/no). SES will be assessed through parental education (categorized as primary or below, junior secondary, senior secondary, or university/college and above). For children with cancer, disease type (e.g., leukemia, lymphoma, brain tumor, bone tumor, or others) and disease status (e.g., stage 1-4, recurrence, years since diagnosis, treatment type such as chemotherapy, radiotherapy, surgery, immunotherapy, transplant, or combination) will be recorded. For children with other chronic illnesses, disease type (e.g., asthma, type 1 diabetes, chronic kidney disease) will be noted. These factors may influence sleep outcomes, e.g., older children may report greater daytime dysfunction, or lower parental education level may limit access to supportive care, necessitating adjustment in statistical analyses to isolate the effects of chronic illness on sleep quality. This study anticipates uncovering significant differences in sleep quality between children hospitalized with cancer, those with other chronic illnesses, and healthy children. The following outcomes are expected: 1. It is hypothesized that children with cancer will exhibit the most severe sleep disturbances among the three groups. Factors such as pain associated with the illness, side effects of chemotherapy, and frequent nighttime medical interventions are likely to result in reduced sleep duration, prolonged sleep latency, and increased sleep fragmentation. Reported data from the PSQI are also expected to place a majority of children with cancer above the clinical threshold for poor sleep. 2. While children with other chronic illnesses are also expected to experience sleep disturbances, these disruptions are likely to be less severe than those observed in children with cancer. For example, conditions such as asthma or diabetes may cause episodic sleep interruptions (e.g., nocturnal coughing or nighttime glucose monitoring), but they are not typically compounded by the environmental and psychological stressors associated with hospitalization. A smaller percentage of this group is anticipated to exceed the clinical threshold for poor sleep on the PSQI. 3. Healthy children are expected to demonstrate the highest sleep quality among the three groups, with results showing near-optimal sleep duration and efficiency. Reported data are anticipated to reflect low levels of sleep disturbances, with the majority of children scoring below the clinical threshold on the PSQI. These findings will provide a baseline for understanding how chronic illnesses and hospitalization affect sleep outcomes.

Conditions

Timeline

Start date
2025-07-02
Primary completion
2026-01-30
Completion
2026-06-30
First posted
2025-08-14
Last updated
2025-08-17

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT07122921. Inclusion in this directory is not an endorsement.