| NCT ID | NCT05402280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ostrava |
| Condition | Sleep Disturbance |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,240 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,240 participants in total. It began in 2022-05-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Darja Jarosova
STUDY DIRECTOR
University of Ostrava
Frequently Asked Questions
Who can join the NCT05402280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Disturbance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05402280 currently recruiting?
Yes, NCT05402280 is actively recruiting participants. Contact the research team at michaela.rybova@osu.cz for enrollment information.
Where is the NCT05402280 trial being conducted?
This trial is being conducted at Ostrava, Czechia.
Who is sponsoring the NCT05402280 clinical trial?
NCT05402280 is sponsored by University of Ostrava. The principal investigator is Darja Jarosova at University of Ostrava. The trial plans to enroll 3,240 participants.