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Clinical Trials/NCT04129918
NCT04129918
Completed
Not Applicable

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

Shin Kong Wu Ho-Su Memorial Hospital1 site in 1 country112 target enrollmentJanuary 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Unit
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Enrollment
112
Locations
1
Primary Endpoint
Subjective sleep quality
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2020
End Date
December 17, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ICU stay for 7 days
  • Endotracheal or Tracheostomy patients

Exclusion Criteria

  • Patients with ear injury
  • Hearing impairment
  • Eye disease or injuries

Outcomes

Primary Outcomes

Subjective sleep quality

Time Frame: Day 3 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire

Subjective sleep quality

Secondary Outcomes

  • Objective sleep quality(baseline, Day 1, Day 2, and Day 3] using Actigraphy)
  • Circadian rhythms(baseline, Day 1, Day 2, and Day 3] using Actigraphy)

Study Sites (1)

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