A study of sleep disorders in patients with chronic pain using actigraphy and sleep diaries.

UMIN ID: UMIN000055607

Registered date:25/09/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Patients with chronic pain
• Date of first enrollment: 2023/06/20
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Bidirectional relationship between pain intensity and sleep parameters
• Secondary Outcome: Sleep satisfaction, sleep efficiency, sleep onset latency, total sleep time, wake time after sleep onset

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients whose pain intensity was less than 3 on the Numerical Rating Scale (NRS) at the examination on the day of consent acquisition. 2) Patients with psychiatric disorders that have a clear impact on pain and sleep. 3) Patients with irregular sleep habits due to their occupation (e.g., three-shift work). 4) Patients who work in jobs that do not allow them to wear an actigraph during the day (e.g., cleaning operations, civil engineering work). 5) Patients who are unable to keep a sleep diary. 6) Patients who are otherwise deemed inappropriate as study subjects by the principal investigator (co-investigator).

Related Information

• Primary Sponsor: Yamaguchi University
• Source(s) of Monetary Support: Scholarship donations for the Department of Anesthesiology, Yamaguchi University Graduate School of Medicine
• Secondary ID(s): 2022-057