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Completed

NCT Number: NCT04129918

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

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Key information

Conditions

Intensive Care Unit Circadian Rhythm Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders Ventilator

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ShinKongHospital

Taipei, 111, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ICU stay for 7 days
  • Endotracheal or Tracheostomy patients

Exclusion criteria

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

Treatment and study plan

light and sound modification (earplugs and eye masks)

Behavioral

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

Primary outcomes

  1. Subjective sleep quality

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

    Subjective sleep quality

  2. Subjective sleep quality

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

    Subjective sleep quality

  3. Subjective sleep quality

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

    Subjective sleep quality

  4. Subjective sleep quality

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

    Subjective sleep quality

Secondary outcomes

  1. Objective sleep quality

    Time frame: baseline, Day 1, Day 2, and Day 3] using Actigraphy

    Objective sleep quality

  2. Circadian rhythms

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Other

Registry information

Official study title

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

Acronym: MICU

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 17, 2019
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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