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

NCT04129918 | Completed

• 1 other identifier: 20190804R
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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. 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. 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).

Conditions

Intensive Care Unit; Ventilator; Sleep Quality; Circadian Rhythm

Keywords

intensive care unit; sleep quality; circadian rhythm

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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 Arms (2)

experimental group

EXPERIMENTAL

ear plugs and eye mask for 3 successive nights

Behavioral: light and sound modification (earplugs and eye masks)

control group

NO INTERVENTION

without ear plugs and eye mask

Interventions

light and sound modification (earplugs and eye masks) BEHAVIORAL

In the experimental group，the patients used earplugs and eye masks during nighttime sleep.

experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU stay for 7 days
• Endotracheal or Tracheostomy patients

You may not qualify if:

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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

ShinKongHospital

Taipei, 111, Taiwan

Location

Related Publications (8)

• 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.

  PMID: 25594808 RESULT

• 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.

  PMID: 25230376 RESULT

• 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.

  PMID: 30215172 RESULT

• 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.

  PMID: 29358448 RESULT

• 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.

  PMID: 27109818 RESULT

• 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.

  PMID: 26785964 RESULT

• 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.

  PMID: 30113379 RESULT

• 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.

  PMID: 29452801 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Light; Ear Protective Devices

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Hui-Mei Chen, PhD

  alice@ntunhs.edu.tw

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study was conducted on 126 patients with 56 subjects in experimental group and 56 in control group in the MICU. Effect of ear plugs \& eye mask on sleep among ICU patients: a randomized control trial The participants were randomly divided into two groups: with ear plugs and eye mask (experimental group) for 3 successive nights and without ear plugs and eye mask (control group). participants were provided a Sequentially numbered opaque sealed envelopes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center, prospective, randomized control trial in the medical intensive care unit of the Shin Kong Wu Ho-Su Memorial Hospital.

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 17, 2019
• Study Start: January 5, 2020
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: February 10, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 12 months after publication
• Access Criteria: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Locations

TW (1)