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JRCT ID: jRCT1040230053

Registered date:27/06/2023

A Study on Prevention of Sleep Disturbances in ICU and CCU Patients by White Noise

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedPatients admitted to ICU/CCU
Date of first enrollment01/07/2023
Target sample size80
Countries of recruitment
Study typeInterventional
Intervention(s)Implementation of care interventions using white noise at night


Primary OutcomeAmong objective sleep quality (total sleep time (min), sleep onset latency (min), mid-awake time (min, frequency), sleep efficiency (%), and sleep stage (min)), mid-awake time (min, frequency) will be the primary endpoint.
Secondary OutcomeSubjective sleep quality (RCSQ score score (depth of sleep, sleep onset latency, nighttime wakefulness, re-entry status, sleep satisfaction)) Incidence of delirium (ICDSC score)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteriaPatients aged 20 years or older admitted to the ICU/CCU at the investigator's facility (Hamamatsu Medical Center)
Exclude criteria1. Patients after cardiopulmonary arrest resuscitation 2. Patients with psychiatric disorders 3. Patients with alcohol or other intoxication 4. Patients who have been judged to have difficulty in communicating due to continuous administration of sedatives or narcotics. 5. Patients who are judged to have delirium from the time of admission. 6. Patients who are judged by the investigator to be unsuitable as subjects. 7. Patients with severe disturbance of consciousness 8. Patients with a diagnosis of dementia 9. Patients with hearing impairment such as tinnitus or hearing loss 10. Patients who used earplugs during the study period

Related Information


Public contact
Name Yuki Yonesaka
Address 328 Tomizuka-cho, Naka-ku, Hamamatsu City Shizuoka Prefecture Shizuoka Japan 432-8580
Telephone +81-53-453-7111
Affiliation Nursing Department
Scientific contact
Name Hirosi Wakisaka
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture Shizuoka Japan 431-3192
Telephone +81-53-43-2111
Affiliation Clinical Nursing Seminar Adult Nursing