Clinical Trials Logo

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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04417556
Study type Interventional
Source Mahidol University
Contact
Status Completed
Phase N/A
Start date July 1, 2020
Completion date June 1, 2021

See also
  Status Clinical Trial Phase
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT04513743 - Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ N/A
Completed NCT03251274 - Bath Machine on Sleep Quality in Nursing Home N/A
Completed NCT04102345 - Lavender vs Zolpidem Sleep Quality During Diagnostic PSG Early Phase 1
Completed NCT03725943 - Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT04562181 - Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index N/A
Completed NCT05102565 - A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers N/A
Completed NCT05576844 - Ai Youmian (Love Better Sleep) for People Living With HIV N/A
Enrolling by invitation NCT04688099 - Synovial Fluid Sleep Study
Recruiting NCT04171245 - Prescribing Laughter for Sleep and Wellbeing in UAE University Students N/A
Completed NCT03758768 - The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms N/A
Completed NCT03163498 - Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
Completed NCT04093271 - Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep Phase 1
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04120363 - Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations Phase 4