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Intensive Care UnitMICUNCT04129918

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

A study testing light and sound modification (earplugs and eye masks) in people with Intensive Care Unit and Ventilator, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Intensive Care Unit, Ventilator, Sleep Quality
What is being tested?
light and sound modification (earplugs and eye masks)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteTaiwan
Study dates
5 Jan 2020to 17 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ICU stay for 7 days
  • Endotracheal or Tracheostomy patients

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • ShinKongHospital

    Taipei, 111

Other trials in Taiwan

About this study

Official title: 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).
Read the 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.

Being tested
light and sound modification (earplugs and eye masks)
Keywords
intensive care unit, sleep quality, circadian rhythm
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • light and sound modification (earplugs and eye masks)Behavioural

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

Study groups in NCT04129918
Study groupRoleWhat they receive
experimental groupExperimentalear plugs and eye mask for 3 successive nights
Receives: Behavioral: light and sound modification (earplugs and eye masks)
control groupNo interventionwithout ear plugs and eye mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective sleep quality

    Subjective sleep quality

    Measured: baseline after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire

  2. Subjective sleep quality

    Subjective sleep quality

    Measured: Day 1 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire

  3. Subjective sleep quality

    Subjective sleep quality

    Measured: Day 2 after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire

  4. Subjective sleep quality

    Subjective sleep quality

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

Secondary outcomes (2)

  1. Objective sleep quality

    Objective sleep quality

    Measured: baseline, Day 1, Day 2, and Day 3] using Actigraphy

  2. 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

    Measured: baseline, Day 1, Day 2, and Day 3] using Actigraphy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2019
  2. Study start5 Jan 2020
  3. Primary completion17 Dec 2020
  4. Study completion17 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a single-center, prospective, randomized control trial in the medical intensive care unit of the Shin Kong Wu Ho-Su Memorial Hospital.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04129918
Sponsor's protocol ID
20190804R
Acronym
MICU
Status last verified
Jan 2020
First submitted
13 Oct 2019
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: partial collected IPD, all IPD that underlie results in a publication

Publications

  • 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.

    PubMed 25594808

  • 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.

    PubMed 25230376

  • 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.

    PubMed 30215172

  • 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.

    PubMed 29358448

  • 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.

    PubMed 27109818

  • 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.

    PubMed 26785964

  • 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.

    PubMed 30113379

  • 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.

    PubMed 29452801

Questions about this trial

What is this clinical trial studying?

A study testing light and sound modification (earplugs and eye masks) in people with Intensive Care Unit and Ventilator, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective sleep quality (time frame: baseline after recruited] using Chinese version of Richards-Campbell Sleep Questionnaire). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04129918, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.

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