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

Intensive Care Unit Clinical Trial

— MICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129918
• Other study ID #: 20190804R
• Status: Completed
• Phase: N/A
• Start date: January 5, 2020
• Est. completion date: December 17, 2020

Study information

• Verified date: January 2020
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 17, 2020
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circadian Rhythm
• Intensive Care Unit
• Sleep Quality
• Ventilator

Intervention

Behavioral:
• light and sound modification (earplugs and eye masks)
In the experimental group,the patients used earplugs and eye masks during nighttime sleep.

Locations

Country	Name	City	State
Taiwan	ShinKongHospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

Beltrami FG, Nguyen XL, Pichereau C, Maury E, Fleury B, Fagondes S. Sleep in the intensive care unit. J Bras Pneumol. 2015 Nov-Dec;41(6):539-46. doi: 10.1590/S1806-37562015000000056. Review. English, Portuguese. — View Citation

Boyko Y, Toft P, Ørding H, Lauridsen JT, Nikolic M, Jennum P. Atypical sleep in critically ill patients on mechanical ventilation is associated with increased mortality. Sleep Breath. 2019 Mar;23(1):379-388. doi: 10.1007/s11325-018-1718-3. Epub 2018 Sep 1 — View Citation

Delaney LJ, Currie MJ, Huang HC, Litton E, Wibrow B, Lopez V, Haren FV. Investigating the application of motion accelerometers as a sleep monitoring technique and the clinical burden of the intensive care environment on sleep quality: study protocol for a — View Citation

Devlin JW, Skrobik Y, Gélinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress — View Citation

Horsten S, Reinke L, Absalom AR, Tulleken JE. Systematic review of the effects of intensive-care-unit noise on sleep of healthy subjects and the critically ill. Br J Anaesth. 2018 Mar;120(3):443-452. doi: 10.1016/j.bja.2017.09.006. Epub 2017 Nov 23. — View Citation

Kamdar BB, Niessen T, Colantuoni E, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Collop NA, Needham DM. Delirium transitions in the medical ICU: exploring the role of sleep quality and other factors. Crit Care Med. 2015 Jan;43(1):135-141. doi: 10.1097/CCM — View Citation

Pisani MA, Friese RS, Gehlbach BK, Schwab RJ, Weinhouse GL, Jones SF. Sleep in the intensive care unit. Am J Respir Crit Care Med. 2015 Apr 1;191(7):731-8. doi: 10.1164/rccm.201411-2099CI. Review. — View Citation

Solverson KJ, Easton PA, Doig CJ. Assessment of sleep quality post-hospital discharge in survivors of critical illness. Respir Med. 2016 May;114:97-102. doi: 10.1016/j.rmed.2016.03.009. Epub 2016 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective sleep quality	Subjective sleep quality	baseline after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire
Primary	Subjective sleep quality	Subjective sleep quality	Day 1 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire
Primary	Subjective sleep quality	Subjective sleep quality	Day 2 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire
Primary	Subjective sleep quality	Subjective sleep quality	Day 3 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire
Secondary	Objective sleep quality	Objective sleep quality	baseline, Day 1, Day 2, and Day 3] using Actigraphy
Secondary	Circadian rhythms	Circadian rhythms including 24-h autocorrelation coefficient (r24), in bed less than out of bed dichotomy index (I	baseline, Day 1, Day 2, and Day 3] using Actigraphy