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Sleep Disturbances and Delirium

Key facts

Who runs it
University of Ostrava
Where
Czechia1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
3,240 people, planned
Started
1 May 2022
Planned end
31 Dec 2025
Type of study
Interventional, 4 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Sleep protocol
Record updated
25 February 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • previous and current treatment for sleep disturbances
  • Patients with cognitive impairment preventing them from cooperating
  • terminal disease
  • neurocognitive dysfunction (dementia)
  • Glasgow Coma Scale score below 12
  • sedative administration over the last 24 hours

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Qualitative studyNo study treatment, for comparison

    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.

  • Prospective quantitative studyNo study treatment, for comparison

    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).

  • Retrospective quantitative studyNo study treatment, for comparison

    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.

  • Interventional studyOther group

    (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.

    Treatment: Sleep protocol

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Sleep Disturbances in Hospitalized Patients as a Risk Factor for Delirium
Record updated
25 February 2025