Improving sleep quality for critically ill patients in the ICU

Multidisciplinary Protocol for Best Pracrice in Sleep for Critically Ill Patients

This study is testing a new sleep plan in the ICU to see if it can help critically ill patients sleep better and reduce confusion.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Moinhos de Vento (Academic / other)
• Locations: 2 sites (Novo Hamburgo, Rio Grande Do Sul and 1 other locations)
• Trial ID: NCT05996861 on ClinicalTrials.gov

What this trial studies

This observational study aims to enhance sleep quality in critically ill patients by implementing a structured sleep protocol in the ICU. It addresses the multifaceted factors contributing to sleep disturbances, including environmental, physiological, and psychological elements. By utilizing the Richards-Campbell Sleep Questionnaire, the study will assess improvements in sleep quality and the incidence of delirium among ICU patients. The goal is to propose effective measures that can be integrated into ICU practices to support better sleep for patients during their critical care.

Who should consider this trial

Good fit: Ideal candidates include adult patients aged 18 and older who have spent at least two nights in the ICU and can respond to a sleep questionnaire.

Not a fit: Patients with severe neuropsychiatric conditions that prevent them from responding to the questionnaire or those who are moribund will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the sleep quality and overall recovery of critically ill patients in the ICU.

How similar studies have performed: Other studies have indicated that structured interventions to improve sleep in ICU settings can lead to better patient outcomes, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Adult patients (18 years or older);
* Have spent at least two nights in the ICU;
* Neuropsychiatric conditions to respond to the sleep questionnaire Informed consent - authorization through the ICF (Informed Consent Form).

Exclusion Criteria:

* Neuropsychiatric conditions that prevent responding to the questionnaire, such as patients with dementia, severe sequelae of cerebrovascular disease, inability to understand and/or communicate, severe encephalopathy, deep sedation, acute brain dysfunction and/or delirium, visual and/or auditory acuity impairments that prevent responding to the questionnaire, active alcoholism, active illicit drug use, severe withdrawal symptoms;
* Patients with deep sedation that does not allow interaction with the evaluator;
* Moribund patients;
* Refusal to participate in the study.

Where this trial is running

Novo Hamburgo, Rio Grande Do Sul and 1 other locations

• Unimed Vale dos Sinos Hospital — Novo Hamburgo, Rio Grande Do Sul, Brazil (Recruiting)
• Moinhos de Vento Hospital — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)

Study contacts

• Principal investigator: Laura Drehmer — Vale dos Sinos Hospital
• Study coordinator: Laura Drehmer

Conditions Sleep Disorders; Sleep; ICU; Delirium; Multidisciplinary Team; Sleep Protocol