NCT07122921 Cross-sectional Study of Sleep Disturbance in Hong Kong Children With Cancer Comparing With Healthy Counterparts and Children With Other Chronic Diseases
| NCT ID | NCT07122921 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Sleep |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 150 participants in total. It began in 2025-07-02 with a primary completion date of 2026-01-30.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: 1. Children with Cancer (n=50) 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. 2. 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. 3. Healthy Children (n=50) 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. Exclusion Criteria: Across all three groups, children will be excluded if they are not Chinese and are in intensive care units. Children who exhibit severe cognitive impairments that preclude accurate reporting of sleep experiences, either by themselves or their parents or legal guardians, will be excluded. Additionally, participants with neurological conditions known to independently affect sleep, such as epilepsy or cerebral palsy, will be excluded to avoid confounding the primary relationship between chronic illness and sleep disturbances. The use of sedative medications unrelated to the participant's primary condition (e.g., for behavioral management rather than cancer treatment) will also disqualify participants, as these could artificially alter sleep patterns and obscure study outcomes. These exclusion criteria ensure that sleep disturbances observed are primarily linked to the participants' health status rather than extraneous factors.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07122921 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07122921 currently recruiting?
Yes, NCT07122921 is actively recruiting participants. Contact the research team at 1155203294@link.cuhk.edu.hk for enrollment information.
Where is the NCT07122921 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07122921 clinical trial?
NCT07122921 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 150 participants.