Development of a care program for children with circadian rhythm sleep-wake disorder

JRCT ID: jRCT1042240087

Registered date:20/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: circadian rhythm sleep-wake disorder
• Date of first enrollment: 20/09/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): The nurse will provide care to the subject five times during the hospitalization. On the day of admission, the second, third, and fourth weeks, and on the day of discharge, the subject child proceeds with the care program booklet in a self-administered format with the nurse. The content of the program includes chronotyping, sleep disorders, sleep hygiene education, and planning a schedule for their own rhythm of life.

Outcome(s)

• Primary Outcome: Circadian Rhythm Sleep-Wake Disorder Acceptance Assessment Questionnaire

Secondary Outcome

(1) Children's Daytime Sleepiness Scale
(2) Athens Insomnia Scale
(3) Sleep diary
(4) Actigraph (bedtime, waking time, continuous sleep time, nocturnal sleep)
(5) Questionnaire for sleep hygiene education evaluation
(6)Symptom scale for circadian rhythm sleep/wake disorders (sleep phase regression type, free continuous type)
(7) Printed copies of care program booklets conducted by research collaborators
(8) Questionnaire for morning and nighttime sleep

Key inclusion & exclusion criteria

• Age minimum: >= 13age old
• Age maximum: <= 19age old
• Gender: Both

Include criteria

Patients who are attending outpatient psychiatric clinics and are (in the process of) being scheduled for hospitalization. Among the patients in the circadian rhythm sleep-wake disorder group, those with delayed sleep-wake phase disorder (DSWPD) and non-24-hour sleep-wake rhythm disorder (N24SWD), who meet the following criteria
1. have given their free and voluntary written consent to participate in this study after receiving a full explanation and with full understanding
2. the subject is an adolescent between 13 and 19 years of age, who has given informed consent and obtained consent from a surrogate (parent)
3. who have been diagnosed with circadian rhythm sleep/wake disorder by their primary care physician or physician in charge, and who are deemed eligible to participate in the study.

• Exclude criteria: If the attending physician, physician in charge, principal investigator, or principal research investigator determines that continuation of the research would be detrimental to the subject, or if a complaint of suicidal ideation (attempt) is heard.

Related Information

• Primary Sponsor: Kitajima Tsuyoshi
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research