Validation of Various Sleep Assessment Tools in SICU

Sleep Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417556
• Other study ID #: 103/2563(IRB2)
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 1, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adult
• Dyssomnias
• Intensive Care Unit
• Parasomnias
• Polysomnography
• Sleep
• Sleep Deprivation
• Sleep Disturbance
• Surveys and Questionnaires

Intervention

Diagnostic Test:
• Sleep measurement
Sleep measurement with polysomnography, actigraphy, and Thai-version Richards Campbell Sleep Questionnaire.

Locations

Country	Name	City	State
Thailand	Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (18)

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Knauert MP, Yaggi HK, Redeker NS, Murphy TE, Araujo KL, Pisani MA. Feasibility study of unattended polysomnography in medical intensive care unit patients. Heart Lung. 2014 Sep-Oct;43(5):445-52. doi: 10.1016/j.hrtlng.2014.06.049. Epub 2014 Jul 12. — View Citation

Krotsetis S, Richards KC, Behncke A, Köpke S. The reliability of the German version of the Richards Campbell Sleep Questionnaire. Nurs Crit Care. 2017 Jul;22(4):247-252. doi: 10.1111/nicc.12275. Epub 2017 Feb 6. — View Citation

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Murata H, Oono Y, Sanui M, Saito K, Yamaguchi Y, Takinami M, Richards KC, Henker R. The Japanese version of the Richards-Campbell Sleep Questionnaire: Reliability and validity assessment. Nurs Open. 2019 Mar 28;6(3):808-814. doi: 10.1002/nop2.252. eCollection 2019 Jul. — View Citation

Nicolás A, Aizpitarte E, Iruarrizaga A, Vázquez M, Margall A, Asiain C. Perception of night-time sleep by surgical patients in an intensive care unit. Nurs Crit Care. 2008 Jan-Feb;13(1):25-33. doi: 10.1111/j.1478-5153.2007.00255.x. — View Citation

Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44. — View Citation

Tryon WW. Issues of validity in actigraphic sleep assessment. Sleep. 2004 Feb 1;27(1):158-65. — View Citation

Weinhouse GL, Schwab RJ, Watson PL, Patil N, Vaccaro B, Pandharipande P, Ely EW. Bench-to-bedside review: delirium in ICU patients - importance of sleep deprivation. Crit Care. 2009;13(6):234. doi: 10.1186/cc8131. Epub 2009 Dec 7. Review. — View Citation

Wolters AE, Slooter AJ, van der Kooi AW, van Dijk D. Cognitive impairment after intensive care unit admission: a systematic review. Intensive Care Med. 2013 Mar;39(3):376-86. doi: 10.1007/s00134-012-2784-9. Epub 2013 Jan 18. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sleep time measured using polosomnography	Total sleep time measured using polysomnography from 8 pm until 6 am next day	10 hours
Primary	Total sleep time measured using wrist actigraphy	Total sleep time measured using wrist actigraphy from 8 pm unitl 6 am next day	10 hours
Primary	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.	10 hours
Secondary	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	10 hours
Secondary	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.	10 hours