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

Not Applicable

Completed

• Conditions: Ventilator; Intensive Care Unit; Sleep Quality; Circadian Rhythm
• Interventions: Behavioral: light and sound modification (earplugs and eye masks)

• Registration Number: NCT04129918
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2019-10-13
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Status Verified: 2020-01
• Study Start: 2020-01-05
• Primary Completion: 2020-12-17
• Study Completion: 2020-12-17
• Last Update Submitted: 2021-02-07
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	light and sound modification (earplugs and eye masks)	ear plugs and eye mask for 3 successive nights

Primary Outcome Measures

Name	Time	Method
Subjective sleep quality	Day 3 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire	Subjective sleep quality

Secondary Outcome Measures

Name	Time	Method
Objective sleep quality	baseline, Day 1, Day 2, and Day 3] using Actigraphy	Objective sleep quality
Circadian rhythms	baseline, Day 1, Day 2, and Day 3] using Actigraphy	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

Trial Locations

Locations (1)

ShinKongHospital; 🇨🇳 Taipei, Taiwan