Validation of Various Sleep Assessment Tools in SICU

NCT04417556 | Completed

• 1 other identifier: 103/2563(IRB2)
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Total sleep time measured using polosomnography

  Total sleep time measured using polysomnography from 8 pm until 6 am next day

  10 hours

• Total sleep time measured using wrist actigraphy

  Total sleep time measured using wrist actigraphy from 8 pm unitl 6 am next day

  10 hours

• 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 Outcomes (2)

• Number of patients with sleep deprivation

  10 hours

• Sleep efficiency measured using polysomnography

  10 hours

Study Arms (1)

Sleep Measurement

EXPERIMENTAL

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

Diagnostic Test: Sleep measurement

Interventions

Sleep measurement DIAGNOSTIC_TEST

Sleep measurement with polysomnography, actigraphy, and Thai-version Richards Campbell Sleep Questionnaire.

Sleep Measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

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

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (18)

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  PMID: 18538194 BACKGROUND

• Gabor JY, Cooper AB, Crombach SA, Lee B, Kadikar N, Bettger HE, Hanly PJ. Contribution of the intensive care unit environment to sleep disruption in mechanically ventilated patients and healthy subjects. Am J Respir Crit Care Med. 2003 Mar 1;167(5):708-15. doi: 10.1164/rccm.2201090.

  PMID: 12598213 BACKGROUND

• Mistraletti G, Carloni E, Cigada M, Zambrelli E, Taverna M, Sabbatini G, Umbrello M, Elia G, Destrebecq AL, Iapichino G. Sleep and delirium in the intensive care unit. Minerva Anestesiol. 2008 Jun;74(6):329-33.

  PMID: 18500209 BACKGROUND

• Kamdar BB, Kamdar BB, Needham DM. Bundling sleep promotion with delirium prevention: ready for prime time? Anaesthesia. 2014 Jun;69(6):527-31. doi: 10.1111/anae.12686. No abstract available.

  PMID: 24813131 BACKGROUND

• 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.

  PMID: 20053301 BACKGROUND

• Nicolas A, Aizpitarte E, Iruarrizaga A, Vazquez 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.

  PMID: 18226052 BACKGROUND

• Bourne RS, Minelli C, Mills GH, Kandler R. Clinical review: Sleep measurement in critical care patients: research and clinical implications. Crit Care. 2007;11(4):226. doi: 10.1186/cc5966.

  PMID: 17764582 BACKGROUND

• Elliott R, McKinley S, Cistulli P, Fien M. Characterisation of sleep in intensive care using 24-hour polysomnography: an observational study. Crit Care. 2013 Mar 18;17(2):R46. doi: 10.1186/cc12565.

  PMID: 23506782 BACKGROUND

• 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.

  PMID: 25023504 BACKGROUND

• de Souza L, Benedito-Silva AA, Pires ML, Poyares D, Tufik S, Calil HM. Further validation of actigraphy for sleep studies. Sleep. 2003 Feb 1;26(1):81-5. doi: 10.1093/sleep/26.1.81.

  PMID: 12627737 BACKGROUND

• 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.

  PMID: 23328935 BACKGROUND

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

  PMID: 11227580 BACKGROUND

• Frisk U, Nordstrom G. Patients' sleep in an intensive care unit--patients' and nurses' perception. Intensive Crit Care Nurs. 2003 Dec;19(6):342-9. doi: 10.1016/s0964-3397(03)00076-4.

  PMID: 14637294 BACKGROUND

• Krotsetis S, Richards KC, Behncke A, Kopke 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.

  PMID: 28168810 BACKGROUND

• 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.

  PMID: 31367403 BACKGROUND

• Berry RB, Brooks R, Gamaldo C, Harding SM, Lloyd RM, Quan SF, Troester MT, Vaughn BV. AASM Scoring Manual Updates for 2017 (Version 2.4). J Clin Sleep Med. 2017 May 15;13(5):665-666. doi: 10.5664/jcsm.6576. No abstract available.

  PMID: 28416048 BACKGROUND

• Bonnet MH, Arand DL. Clinical effects of sleep fragmentation versus sleep deprivation. Sleep Med Rev. 2003 Aug;7(4):297-310. doi: 10.1053/smrv.2001.0245.

  PMID: 14505597 BACKGROUND

• Tryon WW. Issues of validity in actigraphic sleep assessment. Sleep. 2004 Feb 1;27(1):158-65. doi: 10.1093/sleep/27.1.158.

  PMID: 14998254 RESULT

MeSH Terms

Conditions

Parasomnias; Sleep Deprivation

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Dyssomnias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Annop Piriyapatsom, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: July 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: June 1, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)