Sleep Disturbances and Delirium

Официальное название

Sleep Disturbances in Hospitalized Patients as a Risk Factor for Delirium

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Sleep protocol
  To investigate the effect of a multicomponent sleep protocol on the quality of sleep hospitalized patients assessed both subjectively and objectively.

Первичные конечные точки

• Change quality of sleep during hospitalization (subjectively and objectively) [Срок оценки: 25 months]

Вторичные конечные точки (7)

• Change of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) [Срок оценки: 25 months]
• Change of the Confusion Assessment Method (CAM) [Срок оценки: 25 months]
• Change of Ford Insomnia Response to Stress Test: FIRST (self-reported) [Срок оценки: 4 months]
• Change of Sleep in the Intensive Care Unit Questionnaire (SICQ) (self-reported) [Срок оценки: 3 months]
• Change of Questionnaire to ascertain the factors affecting sleep during hospitalization (self-reported) [Срок оценки: 3 months]
• Analyse information about concerning the need for sleep [Срок оценки: up to 1 months]
• Analyse information about compare attitudes and opinions of nurses providing direct care, nurse managers about sleep and his disturbances [Срок оценки: up to 1 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Чехия · 1 центр

• University of Ostrava — Ostrava

Публикации

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• 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. PMID 22486783
• 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. PMID 29522193
• 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. PMID 22701388
• 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. PMID 30215172
• 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. PMID 29976191
• 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, C PMID 30113379

Идентификаторы

NCT: NCT05402280 · SLEEP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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