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

JRCT ID: jRCT1040230053

Registered date:27/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients admitted to ICU/CCU
• Date of first enrollment: 01/07/2023
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Implementation of care interventions using white noise at night

Outcome(s)

• Primary Outcome: Among 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 Outcome

Subjective 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 maximum: Not applicable
• Gender: Both
• Include criteria: Patients aged 20 years or older admitted to the ICU/CCU at the investigator's facility (Hamamatsu Medical Center)

Exclude criteria

1. 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

• Primary Sponsor: Wakisaka Hirosi