NCT05402280: SLEEP

Sleep Disturbances and Delirium

Recruiting now NA Last updated 25 February 2025

What this trial tests

NA trial testing Sleep protocol in Sleep Disturbance in 3,240 participants. Currently enrolling.

Timeline

1 May 2022

Primary endpoint
30 June 2025

31 December 2025

Quick facts

Lead sponsor	University of Ostrava
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	3,240
Start date	1 May 2022
Primary completion	30 June 2025
Estimated completion	31 December 2025
Sites	1 location across Czechia

Drugs / interventions tested

• Sleep protocol

Conditions studied

• Sleep Disturbance — all drugs for Sleep Disturbance →

Sponsor

University of Ostrava

Who can join

18 and older, any sex, with Sleep Disturbance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sleep Quality of Patients on a General Department During the First Days of Hospitalization.
   Locihová H, Jarošová D, Šrámková K, Slonkova J, et al · · 2025 · PMID 40170930 · DOI 10.2147/nss.s501743