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

NCT07122921 | Recruiting

• 1 other identifier: PAED-2025-045
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep; Sleep Disturbances in Children; Sleep Disturbances

Keywords

sleep; sleep disturbance; children; paediatrics

Outcome Measures

Primary Outcomes (2)

• Sleep Quality

  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.

  1 month

• Health-related quality of life

  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.

  1 month

Study Arms (3)

Healthy control

The healthy control group will be of adequate sample size. These include siblings of pediatric patients (both oncology and non-oncology wards), and children of hospital staff (e.g., nurses, administrative personnel). Inclusion criteria require no history of chronic illness, psychiatric disorders, or known sleep conditions. Parental consent and child assent will be obtained for all participants.

Children with Other Chronic Illnesses

This group will comprise children diagnosed with chronic conditions other than cancer, such as asthma, type 1 diabetes, or chronic kidney disease, recruited from the cardiac, nephrology, and mixed wards of Hong Kong Children's Hospital. These illnesses are selected for their known potential to disrupt sleep-e.g., nocturnal asthma symptoms or glucose instability-while differing in pathophysiology from cancer. Participants must be under active management for their condition and currently hospitalized, but must not have a history of primary sleep disorders (e.g., narcolepsy, obstructive sleep apnea) unrelated to their chronic illness. This criterion ensures that observed sleep disturbances are attributable to the chronic condition rather than pre-existing sleep pathology.

Children with Cancer

Participants in this group will be children with a confirmed cancer diagnosis, such as leukemia, lymphoma, or solid tumors, who are currently hospitalized for treatment at the inpatient oncology wards of Hong Kong Children's Hospital. Eligible participants must be actively receiving cancer-directed therapy (e.g., chemotherapy, radiation) during their hospital stay. Inclusion criteria require that participants, or their parents or legal guardians as proxies, can provide accurate reports about sleep patterns, either through self-assessment or observation, ensuring reliable data collection. This group will capture the acute impact of cancer treatment and hospitalization on sleep, a critical focus of the study.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Paediatrics

You may qualify if:

• Children with Other Chronic Illnesses (n=50) This group will comprise children diagnosed with chronic conditions other than cancer, such as asthma, type 1 diabetes, or chronic kidney disease, recruited from the cardiac, nephrology, and mixed wards of Hong Kong Children's Hospital. These illnesses are selected for their known potential to disrupt sleep-e.g., nocturnal asthma symptoms or glucose instability-while differing in pathophysiology from cancer. Participants must be under active management for their condition and currently hospitalized, but must not have a history of primary sleep disorders (e.g., narcolepsy, obstructive sleep apnea) unrelated to their chronic illness. This criterion ensures that observed sleep disturbances are attributable to the chronic condition rather than pre-existing sleep pathology.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Shuk Yan Mak

CONTACT

(852)62229509; 1155203294@link.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Ward Manager (Paed)

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: July 2, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)