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Validation of Various Sleep Assessment Tools in SICU

Primary Purpose

Sleep, Sleep Disturbance, Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Sleep measurement
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep focused on measuring Sleep Disturbance, Sleep Measurement Tools, Polysomnography, Actigraphy, Richards Campbell Questionnaire, Validation, Surgical Intensive Care Unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient whose age ≥ 18 years old.
  • Patients who are anticipated to stay in surgical intensive care unit at least one full night (from 8 p.m. to 6 a.m. next day).
  • Patients who can answer the questionnaires and can communicate, read and write in Thai.

Exclusion Criteria:

  • Patients with severe cognitive impairment, dementia, Richmond Agitation Sedation Scale (RASS) score of less than -2 or more than +1 or those receiving neuromuscular blocking agents.
  • Patients with pathological lesions that preclude applying electrodes and sensors of polysomnography or applying actigraphy.
  • Patients with high acuity of illness whose ICU survival is not expected.

Sites / Locations

  • Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sleep Measurement

Arm Description

Sleep Measurement arm, sleep are simultaneously measured using polosomgraphy, actigraphy and Thai-version Richards Campbell Sleep Questionnaire.

Outcomes

Primary Outcome Measures

Total sleep time measured using polosomnography
Total sleep time measured using polysomnography from 8 pm until 6 am next day
Total sleep time measured using wrist actigraphy
Total sleep time measured using wrist actigraphy from 8 pm unitl 6 am next day
Sleep measurement using Thai-version Richards Campbell Sleep Questionnaire
Sleep measurement using five-item, visual analogue scale, Thai-version Richards Campbell Sleep Questionnaire, which range from 0 to 100 mm and the higher scores indicate a better quality of sleep.

Secondary Outcome Measures

Number of patients with sleep deprivation
Number of patients with sleep deprivation, which is defined as total sleep time of less than 5 hours measured using polysomnography
Sleep efficiency measured using polysomnography
Sleep efficiency measured using polysomnography from 8 pm until 6 am next day and defined as the ratio of total sleep time to time in bed.

Full Information

First Posted
June 1, 2020
Last Updated
May 15, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04417556
Brief Title
Validation of Various Sleep Assessment Tools in SICU
Official Title
Validation of Sleep Assessment Tools in the Surgical Intensive Care Unit: Comparison of Thai Version of Richards-Campbell Sleep Questionnaire, Actigraphy, and Polysomnography
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sleep deprivation is common in critical patients and it can cause impair consolidation of memory, cognitive function, metabolic function, immune, neurological and respiratory system as well as worsen the quality of life after discharge. It has been demonstrated that reducing sleep disturbance could attenuate the development of delirium in ICU patients. However, sleep evaluation is only personal perception. There are various methods for sleep monitoring, in which the most commonly mentioned methods include polysomnography, actigraphy, and the Richards-Campbell Sleep Questionnaire (RCSQ). The aims of this study is to validate the accuracy of the Thai-version RCSQ and actigraphy for sleep measurement compared to polysomnography, which is considered as the gold-standard in Thai critically ill patients admitted to surgical intensive care unit.
Detailed Description
Sleep is a periodic, reversible state of reduced consciousness, and response to external stimuli. A total sleep duration of normal human sleep is approximately 7-8 hours per night. Sleep deprivation is common in critical patients and it can cause impair consolidation of memory, cognitive function, metabolic function, immune, neurological and respiratory system as well as worsen the quality of life after discharge. The impact of sleep deprivation in critically ill patients is gaining attention as it links between sleep loss and delirium. It has been demonstrated that reducing sleep disturbance could attenuate the development of delirium in ICU patients. However, sleep evaluation is only personal perception and the previous study expressed that medical personnel evaluation still showed some error in approximately 56%. There are various methods for sleep monitoring, in which the most commonly mentioned methods include polysomnography, actigraphy, and the Richards-Campbell Sleep Questionnaire (RCSQ). Polysomnography is considered as the gold standard for monitoring the quantity and quality of sleep. Although, it is difficult to apply in critical care as it requires expensive setup and maintenance and is prone to patient dislodgment and electrical interference leading to low quality of signals and missed interpretation. Nowadays, actigraphy has been used to assess patterns of rest and activity, which can distinguish sleep from wakefulness. The advantage of actigraphy is easy to use and non-invasive, can be used by non-specialists, and allows continuous measurement over days to weeks. On the other hand, its disadvantages are such as neuromuscular weakness and increases risk of overestimating sleep quantity as periods of inactivity scored as sleep. However, the technology has been improved recently leading to more accurate sleep measurement. Although it has been shown that actigraphy is a good alternative sleep measure in non-ICU patients, the accuracy of actigraphy is unknown in ICU patients. For subjective tool for evaluating sleep, the Richards-Campbell Sleep Questionnaire (RCSQ) is one of the most commonly used questionnaires. It contains a simple five-item questionnaire which are sleep depth, ability to fall asleep, number of awakening, ability to fall asleep when awake and quality of sleep. The RCSQ shows a good correlation with polysomnography in sleep efficacy index. The advantages of RCSQ are easy-to-use, inexpensive and providing good quality of sleep assessment. It has been widely used in the United States and many countries. Moreover, it has been translated to many languages, such as Spanish, Swedish, German, and Japanese; and the translated version of RCSQ can be used as an alternative sleep measurement to polysomnography. Currently, our research group is translating the RCSQ into Thai version by using standard guidelines on the translation process. In spite of this, The Thai version of RCSQ (T-RCSQ) has not been validated with polysomnography before. The aims of our study are to validate the accuracy of the T-RCSQ for sleep measurement compared to polysomnography, which is considered as the gold-standard and to access the accuracy of actigraphy for monitoring sleep quality and quantity compared to polysomnography in Thai critically ill patients admitted to surgical intensive care unit (SICU).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Sleep Disturbance, Sleep Deprivation, Polysomnography, Surveys and Questionnaires, Intensive Care Unit, Adult
Keywords
Sleep Disturbance, Sleep Measurement Tools, Polysomnography, Actigraphy, Richards Campbell Questionnaire, Validation, Surgical Intensive Care Unit

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Measurement
Arm Type
Experimental
Arm Description
Sleep Measurement arm, sleep are simultaneously measured using polosomgraphy, actigraphy and Thai-version Richards Campbell Sleep Questionnaire.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sleep measurement
Intervention Description
Sleep measurement with polysomnography, actigraphy, and Thai-version Richards Campbell Sleep Questionnaire.
Primary Outcome Measure Information:
Title
Total sleep time measured using polosomnography
Description
Total sleep time measured using polysomnography from 8 pm until 6 am next day
Time Frame
10 hours
Title
Total sleep time measured using wrist actigraphy
Description
Total sleep time measured using wrist actigraphy from 8 pm unitl 6 am next day
Time Frame
10 hours
Title
Sleep measurement using Thai-version Richards Campbell Sleep Questionnaire
Description
Sleep measurement using five-item, visual analogue scale, Thai-version Richards Campbell Sleep Questionnaire, which range from 0 to 100 mm and the higher scores indicate a better quality of sleep.
Time Frame
10 hours
Secondary Outcome Measure Information:
Title
Number of patients with sleep deprivation
Description
Number of patients with sleep deprivation, which is defined as total sleep time of less than 5 hours measured using polysomnography
Time Frame
10 hours
Title
Sleep efficiency measured using polysomnography
Description
Sleep efficiency measured using polysomnography from 8 pm until 6 am next day and defined as the ratio of total sleep time to time in bed.
Time Frame
10 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient whose age ≥ 18 years old. Patients who are anticipated to stay in surgical intensive care unit at least one full night (from 8 p.m. to 6 a.m. next day). Patients who can answer the questionnaires and can communicate, read and write in Thai. Exclusion Criteria: Patients with severe cognitive impairment, dementia, Richmond Agitation Sedation Scale (RASS) score of less than -2 or more than +1 or those receiving neuromuscular blocking agents. Patients with pathological lesions that preclude applying electrodes and sensors of polysomnography or applying actigraphy. Patients with high acuity of illness whose ICU survival is not expected.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annop Piriyapatsom, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan of sharing.
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Validation of Various Sleep Assessment Tools in SICU

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