Sleep Disturbances and Delirium

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ostrava

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients with cognitive impairment preventing them from cooperating

Glasgow Coma Scale score below 12

terminal disease

previous and current treatment for sleep disturbances

Trial design

Treatments tested in this trial

  • Sleep protocol

Treatment groups

3,240 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Ostrava

Lead sponsor

University Hospital Ostrava

Collaborator

General University Hospital, Prague

Collaborator