Effects of Light and Sound Modification on Sleep Quality and Circadian Rhythm in the MICU Patients

Study Overview
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Brief Summary
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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: 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). 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
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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.

Official Title
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Effects of Light and Sound Modification on Sleep Quality and Circadian Rhythm in the Medical Intensive Care Unit Patients

Conditions
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Intensive Care Unit, Ventilator, Sleep Quality, Circadian Rhythm

Intervention / Treatment
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* Behavioral: light and sound modification (earplugs and eye masks)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU stay for 7 days Endotracheal or Tracheostomy patients Exclusion Criteria: Patients with ear injury Hearing impairment Eye disease or injuries

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>ear plugs and eye mask for 3 successive nights | Behavioral: light and sound modification (earplugs and eye masks)<br>* In the experimental group，the patients used earplugs and eye masks during nighttime sleep.<br>|
| No Intervention: control group<br>without ear plugs and eye mask | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleep quality | Subjective sleep quality | baseline after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire | 
| Subjective sleep quality | Subjective sleep quality | Day 1 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire | 
| Subjective sleep quality | Subjective sleep quality | Day 2 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire | 
| Subjective sleep quality | Subjective sleep quality | Day 3 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective sleep quality | Objective sleep quality | baseline, Day 1, Day 2, and Day 3] using Actigraphy | 
| Circadian rhythms | Circadian rhythms including 24-h autocorrelation coefficient (r24), in bed less than out of bed dichotomy index (I<O) collection, Mesor, Amplitude, and Acrophase from actigraphy | baseline, Day 1, Day 2, and Day 3] using Actigraphy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care unit, sleep quality, circadian rhythm