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

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

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).

Study Overview

• Status: Completed
• Conditions: Sleep Quality; Circadian Rhythm; Intensive Care Unit; Ventilator
• Intervention / Treatment: Behavioral: light and sound modification (earplugs and eye masks)

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 111
    • ShinKongHospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
• Investigators: Study Chair: Hui-Mei Chen, PhD, alice@ntunhs.edu.tw

Publications and helpful links

General Publications

• Devlin JW, Skrobik Y, Gelinas 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 JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
• 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.
• 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.0000000000000610.
• Boyko Y, Toft P, Ording 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 13.
• 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 prospective observational study in Australia. BMJ Open. 2018 Jan 21;8(1):e019704. doi: 10.1136/bmjopen-2017-019704.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2020
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: October 13, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 7, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: intensive care unit; circadian rhythm; sleep quality
• Other Study ID Numbers: 20190804R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: partial collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 12 months after publication
• IPD Sharing Access Criteria: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No