- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05402280
Sleep Disturbances and Delirium (SLEEP)
September 18, 2023 updated by: University of Ostrava
Sleep Disturbances in Hospitalized Patients as a Risk Factor for Delirium
Delirium is a frequent and serious problem in hospitalized patients; it is associated with multiple hospital-acquired complications.
There is evidence that the incidence of deliri-um may be minimized by multimodal interventions (pain management, shortening the duration of mechanical ventilation, light sedation, avoiding benzodiazepines, routine delirium monitoring, and early mobilization).
Even though a clear association between sleep and delirium has not been established, many studies suggest that sleep disturban-ces may be a key risk factor for the development of delirium.
Therefore, sleep promoti-on is becoming an integral part of clinical care.
The project support the hypothesis that non-pharmacological preventive interventions promoting sleep (sleep protocol) positive-ly influence the quality of sleep and reduce the incidence of delirium in hospitalized patients.
This will be verified by qualitative and quantitative research methods, with the quantitative study being divided into three prospective cross-sectional studies and one interventional study.
Data will be obtained from 3240 hospitalized patients by combi-ning subjective methods (questionnaire surveys) and objective measurements (acti-graphy).
The project outcomes will allow better understanding of the relationship betwe-en sleep and delirium.
A set of non-pharmacological preventive interventions promoting sleep will be developed, with a subsidiary aim to potentially reduce the incidence of delirium in hospitalized patients.
Study Overview
Detailed Description
Sleep is one of the most important physiological needs.
Sleep disturbances have detri-mental effects on practically all systems and may thus prolong recovery of patients.
Studies have documented many similarities between clinical and physiological profiles of patients with delirium and sleep disturbances (ischemia/inflammation, hypoxia, neu-rotransmitter imbalance and tryptophan/melatonin metabolism abnormalities).
There is still a lack of strong evidence to support the link between poor sleep and delirium, par-ticularly in hospitalized patients, even though available studies suggest that sleep dis-turbances may be a potential key risk factor for its development, which may have a significant clinical impact.
Low awareness of the negative impact of sleep disturbances on the organism and the options for improving sleep may influence the attitude of health professionals to fulfilling this basic human need.The aim of the study is to assess the quality of sleep in patients staying in general wards and intensive care units, identify disruptive factors responsible for its reduced quality, evaluate the relationship between sleep quality and delirium and verify the effectiveness of preventive measures (sleep protocol) in clinical practice.
The aims of the study will be met by combining the fol-lowing methods qualitative research, a cross-sectional analytical study and an interven-tional study.
The quantitative part of the research will be divided into three consecutive cross-sectional analytical studies.
The aim of cross-sectional study I will be to assess the diagnostic properties of the selected instrument (FIRST) for identification of patients predisposed to situational sleep disturbances.
This will be immediately followed by cross-sectional study II aimed to identify factors most disrupting sleep of hospitalized patients and, subsequently, by cross-sectional study III subjectively and objectively as-sessing sleep quality and its relationship with delirium, this phase also will be an evalua-tion of routine care (PRE phase), which will be smoothly followed by intervention stud-ies..
The quantitative part is divided into the three cross-sectional studies not only to meet the subgoals and ensure seamless continuity but also because of the patient sam-ple.
The patient subgroups are diverse, being specified in detail for each study and se-lected based on the inclusion and exclusion criteria.
Study Type
Interventional
Enrollment (Estimated)
3240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michaela Rybova
- Phone Number: +420608714997
- Email: michaela.rybova@osu.cz
Study Locations
-
-
Česká Republika
-
Ostrava, Česká Republika, Czechia, 70300
- Recruiting
- University of Ostrava
-
Contact:
- Michaela Rybova
- Phone Number: +420608714997
- Email: michaela.rybova@osu.cz
-
Sub-Investigator:
- Karel Sonka, prof.
-
Sub-Investigator:
- Jana Slonkova, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age over 18 years
- a hospital stay longer than 24 hours
- a hospital stay longer than 36 hours
- hospitalized for at least 72 hours, without previous sleep disturbances, without cognitive impairment
Exclusion Criteria:
- Patients with cognitive impairment preventing them from cooperating
- Glasgow Coma Scale score below 12
- terminal disease
- previous and current treatment for sleep disturbances
- neurocognitive dysfunction (dementia)
- sedative administration over the last 24 hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Qualitative study
15 nurses (direct care nurses, nurse managers) and 5 patients, to investigate experiences and compare attitudes and opinions concerning the need for and quality of sleep in hospitalized patients.
|
|
No Intervention: Prospective quantitative study
diagnosing predisposition to sleep disturbances: 400 inpatients staying in gene-ral wards: Patients will undergo a serial of structured and standardized questi-onnaires during scheduled: FIRST: on the day of admission and RCSQ during their hospital stay (record length of up to 7 days).
|
|
No Intervention: Retrospective quantitative study
subjective assessment of factors affecting sleep: 600 hospitalized patients (360 patients in general wards, 240 patients in intensive care wards).
On the day of discharge, patients will retrospectively assess disruptive factors that could in-fluence the quality of their sleep during their hospital stay by standardized que-stionnaire.
|
|
Other: Interventional study
(subjective and objective assessment of sleep, quality of sleep with respect to delirium, baseline - routine care: PRE phase) implementation of sleep protocol and assess effectiveness (POST phase: determining the effectiveness of imple-mented sleep measures): overal: 2240 patients (1480 general ward, 760 inten-sive care wards.
|
To investigate the effect of a multicomponent sleep protocol on the quality of sleep hospitalized patients assessed both subjectively and objectively.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change quality of sleep during hospitalization (subjectively and objectively)
Time Frame: 25 months
|
Assessment of quality of sleep using Richards Campbell Sleep Questionnaire (RCSQ) five-item visual analogue scale was designed as an outcome measure for assessing the perception of sleep in patients.
The RCSQ contains 5 items (sleep depth, sleep latency, awakenings, returning to sleep and sleep quality) plus noise as an optional item (evaluated separately).
Each item is scored by using a 0-100 visual analogue scale.
The total score is calculated as the mean of all items, with 0 and 100 representing the worst and best sleep, respectively.
Objectively sleep were assed by actigraphy -the method collects and stores data generated by patient movements.
|
25 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Time Frame: 25 months
|
This is a two-step assessment of delirium.
The first step is to assess arousal with the Richmond Agitation and Sedation Scale.
The second step is assessment of the presence/absence of delirium using four features; delirium is ruled out when none of them is present.
|
25 months
|
Change of the Confusion Assessment Method (CAM)
Time Frame: 25 months
|
The instrument assesses the presence/absence of delirium using four features; delirium is ruled out when none of them is present.
|
25 months
|
Change of Ford Insomnia Response to Stress Test: FIRST (self-reported)
Time Frame: 4 months
|
The instrument comprises 9 items (scenarios) to identify individuals predisposed to situational sleep disturbances.
The FIRST consists of 9 items which are scored on a four point-scale.
High scores are indicative of greater vulnerability to sleep disruption.
Total FIRST scores range from 9 to 36.
|
4 months
|
Change of Sleep in the Intensive Care Unit Questionnaire (SICQ) (self-reported)
Time Frame: 3 months
|
The most widely used instrument for assessing factors causing sleep disturbances in the ICU.
The final version contains 27 items divided into 4 dimensions (sleep quality, daytime sleepiness, disruptive factors produce by the healthcare team and environmental disruptive factors).
The ratings use a 1-10 Likert scale.
|
3 months
|
Change of Questionnaire to ascertain the factors affecting sleep during hospitalization (self-reported)
Time Frame: 3 months
|
Scale used for measuring disturbances factors.
Questionnaire contains 23 items divided into 4 dimensions (factors - physical, physiological, environmental and psychological).
The ratings use a 1-4 Likert scale.
The following ranges are used to grade the severity of sleep disturbances: mild sleep disturbances range 0 - 30, moderate disturbances 31 - 60 and severe disturbances 61 - 92.
|
3 months
|
Analyse information about concerning the need for sleep
Time Frame: up to 1 months
|
Semi-structured interviews with inpatiens.
|
up to 1 months
|
Analyse information about compare attitudes and opinions of nurses providing direct care, nurse managers about sleep and his disturbances
Time Frame: up to 1 months
|
Semi-structured interviews with nurses.
|
up to 1 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Darja Jarosova, University of Ostrava
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
- Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
- Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
- Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.
- Wesselius HM, van den Ende ES, Alsma J, Ter Maaten JC, Schuit SCE, Stassen PM, de Vries OJ, Kaasjager KHAH, Haak HR, van Doormaal FF, Hoogerwerf JJ, Terwee CB, van de Ven PM, Bosch FH, van Someren EJW, Nanayakkara PWB; "Onderzoeks Consortium Acute Geneeskunde" Acute Medicine Research Consortium. Quality and Quantity of Sleep and Factors Associated With Sleep Disturbance in Hospitalized Patients. JAMA Intern Med. 2018 Sep 1;178(9):1201-1208. doi: 10.1001/jamainternmed.2018.2669.
- Alessi CA, Martin JL, Webber AP, Alam T, Littner MR, Harker JO, Josephson KR. More daytime sleeping predicts less functional recovery among older people undergoing inpatient post-acute rehabilitation. Sleep. 2008 Sep;31(9):1291-300.
- Altman MT, Knauert MP, Murphy TE, Ahasic AM, Chauhan Z, Pisani MA. Association of intensive care unit delirium with sleep disturbance and functional disability after critical illness: an observational cohort study. Ann Intensive Care. 2018 May 8;8(1):63. doi: 10.1186/s13613-018-0408-4.
- Bakken LN, Kim HS, Finset A, Lerdal A. Stroke patients' functions in personal activities of daily living in relation to sleep and socio-demographic and clinical variables in the acute phase after first-time stroke and at six months of follow-up. J Clin Nurs. 2012 Jul;21(13-14):1886-95. doi: 10.1111/j.1365-2702.2011.04014.x. Epub 2012 Apr 4.
- Bertisch SM, Pollock BD, Mittleman MA, Buysse DJ, Bazzano LA, Gottlieb DJ, Redline S. Insomnia with objective short sleep duration and risk of incident cardiovascular disease and all-cause mortality: Sleep Heart Health Study. Sleep. 2018 Jun 1;41(6):zsy047. doi: 10.1093/sleep/zsy047.
- Bihari S, Doug McEvoy R, Matheson E, Kim S, Woodman RJ, Bersten AD. Factors affecting sleep quality of patients in intensive care unit. J Clin Sleep Med. 2012 Jun 15;8(3):301-7. doi: 10.5664/jcsm.1920.
- Boyko Y, Toft P, Ording H, Lauridsen JT, Nikolic M, Jennum P. Atypical sleep in critically ill patients on mechanical ventilation is associated with increased mortality. Sleep Breath. 2019 Mar;23(1):379-388. doi: 10.1007/s11325-018-1718-3. Epub 2018 Sep 13.
- Delaney LJ, Currie MJ, Huang HC, Lopez V, Van Haren F. "They can rest at home": an observational study of patients' quality of sleep in an Australian hospital. BMC Health Serv Res. 2018 Jul 5;18(1):524. doi: 10.1186/s12913-018-3201-z.
- Drake C, Richardson G, Roehrs T, Scofield H, Roth T. Vulnerability to stress-related sleep disturbance and hyperarousal. Sleep. 2004 Mar 15;27(2):285-91. doi: 10.1093/sleep/27.2.285.
- Flannery AH, Oyler DR, Weinhouse GL. The Impact of Interventions to Improve Sleep on Delirium in the ICU: A Systematic Review and Research Framework. Crit Care Med. 2016 Dec;44(12):2231-2240. doi: 10.1097/CCM.0000000000001952.
- Patel J, Baldwin J, Bunting P, Laha S. The effect of a multicomponent multidisciplinary bundle of interventions on sleep and delirium in medical and surgical intensive care patients. Anaesthesia. 2014 Jun;69(6):540-9. doi: 10.1111/anae.12638.
- Smith MT, McCrae CS, Cheung J, Martin JL, Harrod CG, Heald JL, Carden KA. Use of Actigraphy for the Evaluation of Sleep Disorders and Circadian Rhythm Sleep-Wake Disorders: An American Academy of Sleep Medicine Systematic Review, Meta-Analysis, and GRADE Assessment. J Clin Sleep Med. 2018 Jul 15;14(7):1209-1230. doi: 10.5664/jcsm.7228.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
May 19, 2022
First Submitted That Met QC Criteria
May 30, 2022
First Posted (Actual)
June 2, 2022
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 18, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLEEP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Disturbance
-
Università degli Studi di BresciaCompletedSleep Phase Rhythm DisturbanceItaly
-
The First Affiliated Hospital of Xiamen UniversityNot yet recruitingPostoperative Sleep Disturbance
-
University of BergenGlamoxCompletedSleep | Sleep Deprivation | Shift-Work Related Sleep DisturbanceNorway
-
Riphah International UniversityCompletedSleep Disturbance in AthletesPakistan
-
Sam Houston State UniversityThe University of Texas Health Science Center, Houston; Memorial Hermann Texas...CompletedSleep Disturbance in Hospitalized Antepartum PatientsUnited States
-
Pacific UniversityCompletedInsomnia | Shift-Work Related Sleep DisturbanceUnited States
-
Erasmus Medical CenterNational Institute for Public Health and the Environment (RIVM); Netherlands...RecruitingShift-Work Related Sleep DisturbanceNetherlands
-
University of California, San FranciscoRecruiting
-
University of North Carolina, Chapel HillWinclove Probiotics B.V.; National Strength and Conditioning Association FoundationCompletedHealthy | Shift-Work Related Sleep DisturbanceUnited States
-
University of ArizonaWalter Reed Army Institute of Research (WRAIR)CompletedSleep Deprivation | Caffeine | Shift-Work Related Sleep DisturbanceUnited States
Clinical Trials on Sleep protocol
-
The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR); Children's Hospital Medical...Completed
-
University of PittsburghNational Institute on Drug Abuse (NIDA)Recruiting
-
University of ZurichCompleted
-
Brigham and Women's HospitalCompleted
-
Hospital Moinhos de VentoRecruiting
-
Sam Houston State UniversityThe University of Texas Health Science Center, Houston; Memorial Hermann Texas...CompletedSleep Disturbance in Hospitalized Antepartum PatientsUnited States
-
Hospital de Clinicas de Porto AlegreCompletedMuscle Weakness | Obstructive Sleep Apnea | Swallowing Disorder | Muscle Disorder | Face | Breathing, Sleep-DisorderedBrazil
-
Western University, CanadaCompletedSleep Disturbance | Borderline Personality DisorderCanada
-
Craig HospitalColorado Traumatic Brain Injury Trust FundCompletedTraumatic Brain InjuryUnited States
-
Oregon Health and Science UniversityRecruitingCardiovascular Diseases | Hypertension | Sleep | Cardiovascular Risk Factors | Circadian RhythmsUnited States