Objective effects of a program to improve insomnia in hospitalized stroke patients: a pilot RCT

UMIN ID: UMIN000053635

Registered date:17/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Stroke (cerebral infarction, cerebral hemorrhage)
• Date of first enrollment: 2024/02/16
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Undergo a 2-week program to improve insomnia (sleep hygiene education, relaxation methods)
Receive usual care (care provided in the hospital ward)

Outcome(s)

• Primary Outcome: The amount of pre- and post-intervention change in the 7-day averages of objective sleep assessments: sleep latency, sleep efficiency, total sleep time, time of mid-wake, and number of mid-wake

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: Persons with severe complications or physical symptoms that prevent the program from being implemented Persons with sleep disorders other than insomnia Persons taking regular oral sleeping pills Persons with dementia Persons with a diagnosis of depression or mental illness Those with physical illnesses (chronic obstructive pulmonary disease, bronchial asthma, heart failure, renal dialysis, rheumatic diseases, fibromyalgia, atopic dermatitis) that accompany sleep disorders

Related Information

• Primary Sponsor: Toyohashi Sozo University
• Source(s) of Monetary Support: Toyohashi Sozo University