Clinical trial NCT04129918: Effects of Light and Sound Modification on Sleep Quality and Circadian Rhythm in the MICU Patients
Official title: Effects of Light and Sound Modification on Sleep Quality and Circadian Rhythm in the Medical Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit
Ventilator
Sleep Quality
Circadian Rhythm
Keywords: intensive care unit
sleep quality
circadian rhythm
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, prospective, randomized control trial in the medical intensive care unit of the Shin Kong Wu Ho-Su Memorial Hospital.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will investigate the effectiveness of light and sound modification in improving sleep qualit , and circadian rhythms in MICU patients with Mechanical Ventilation in Taiwan.

Hypothesis:

1. The sleep quality in intervention group is significant improving than usual-care group at Day 1 (after the first intervention), Day 2 (after the second intervention), and Day 3 (after the third intervention).
2. The circadian rhythm in intervention group is significant improving than usual-care group at Day 1 (after the first intervention), Day 2 (after the second intervention), Day 3 (after the third intervention).

Detailed description: The subjects were divided into experimental and control groups. And the improving quality of sleep intervention was provided only in experimental group. In the experimental group，the patients used earplugs and eye masks during nighttime sleep. In the control group, the received routine intensive care.

Eligibility criteria: Inclusion Criteria:

1. ICU stay for 7 days
2. Endotracheal or Tracheostomy patients

Exclusion Criteria:

1. Patients with ear injury
2. Hearing impairment
3. Eye disease or injuries

Primary outcomes:
measure: Subjective sleep quality
timeFrame: baseline after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire
measure: Subjective sleep quality
timeFrame: Day 1 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire
measure: Subjective sleep quality
timeFrame: Day 2 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire
measure: Subjective sleep quality
timeFrame: Day 3 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire
Secondary outcomes:
measure: Objective sleep quality
timeFrame: baseline, Day 1, Day 2, and Day 3] using Actigraphy
measure: Circadian rhythms
timeFrame: baseline, Day 1, Day 2, and Day 3] using Actigraphy
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: ShinKongHospital
Study officials:
affiliation: alice@ntunhs.edu.tw
name: Hui-Mei Chen, PhD
role: STUDY_CHAIR
References:
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