Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
100 participants
OBSERVATIONAL
2023-03-20
2024-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of a Multifaceted Intervention of Environment Control in the ICU to Optimize Quantity and Quality of Sleep
NCT05694052
Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance
NCT01061242
Sleep/Wake Protocol Implementation to Improve Sleep Quality in the ICU
NCT03313115
Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU
NCT06346613
Chronic Sleep Restriction
NCT01493661
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Critically ill patients are particularly vulnerable to sleep disorders. In the context of critical illness and ICU admission, there is an intersection of factors contributing to this situation: pre-existing health conditions, severe acute illness, sleep-altering treatments (sedatives, analgesics, mechanical ventilation), psychiatric disorders, and the physical environment. In addition to the impact during hospitalization, the literature points to a long-term reduction in quality of life due to sleep disturbance. Recent studies following up on patients after ICU discharge reveal high rates of sleep disorders up to 6 months after hospital discharge - related or unrelated to new psychiatric disorders and even cognitive changes. Furthermore, sleep disorders are associated with an increased incidence of delirium in ICUs, which refers to altered consciousness and cognition in patients admitted to the intensive care environment, which are associated with worsened patient outcomes such as increased hospital stay and consequently the risk of fatal complications. The prevalence of delirium is around 70%, with an incidence of 89%. Delirium assessment in ICUs is usually performed daily.
In order to improve the sleep quality of this population, there are modifiable factors, whether environmental (lighting, noise, general care), physiological (medications, ventilatory parameter adjustments), or psychological (anxiety, pain, absence of family members). Routines to control environmental factors in ICUs seem to have an impact on reducing the incidence of acute brain dysfunction - delirium - and could help prevent sleep disturbances in critically ill patients. These measures include dimming or reducing corridor lights at night, grouping (when possible) care activities at appropriate times, raising curtains, and encouraging mobilization during daytime shifts. For non-delirious patients, the use of earplugs and eye masks is also recommended.
Therefore, the investigators have developed this research project with the aim of evaluating the implementation of a multifaceted and multidisciplinary protocol to promote an improvement in sleep quality in critically ill patients.
The SPIRIT Protocol is a summary of recommendations for clinical trials, which was used as a support in this study. This is a multicenter clinical trial with a quasi-experimental design.
The first step consists of assessing the sleep quality in sequential patients admitted to the ICU and characterizing the disruptive elements.
After this period, the second step will involve sensitizing and training the multidisciplinary team about the importance of sleep for critically ill patients and providing training for the implementation of a multifaceted protocol of interventions to promote sleep quality improvement.
Once the multidisciplinary protocol is implemented, the sleep quality of the patients and the clinical impact of this protocol will be reevaluated.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pre-sleep protocol group
Patients with inclusion criteria assessed before the implementation of the sleep protocol.
No interventions assigned to this group
Post-sleep protocol group
Patients with inclusion criteria after the implementation of the sleep protocol.
ICU sleep protocol
Adjusting sound intensity, as well as reducing noise: efforts will be made to minimize staff conversation volume during the night.
Earplugs will be offered, along with the provision of eye masks for lucid patients, and thermal comfort adjustments will be made, such as providing blankets and/or adjusting room temperature.
Dimming of lights starting from 10 PM. Reduced circulation of external services between 11 PM and 6 AM, and rationalization of sample collections and/or patient transfers between beds during the 11 PM to 6 AM interval.
Optimization of analgesics for better pain control; optimization of medication use during wakefulness when clinically feasible; adjustment of intervals for capillary blood glucose measurement; maintaining and/or resuming the use of chronic sleep medications. If the patient has been unable to sleep, a hypnotic medication will be offered.
Other considerations include suggesting ventilatory support measures for selected patients.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ICU sleep protocol
Adjusting sound intensity, as well as reducing noise: efforts will be made to minimize staff conversation volume during the night.
Earplugs will be offered, along with the provision of eye masks for lucid patients, and thermal comfort adjustments will be made, such as providing blankets and/or adjusting room temperature.
Dimming of lights starting from 10 PM. Reduced circulation of external services between 11 PM and 6 AM, and rationalization of sample collections and/or patient transfers between beds during the 11 PM to 6 AM interval.
Optimization of analgesics for better pain control; optimization of medication use during wakefulness when clinically feasible; adjustment of intervals for capillary blood glucose measurement; maintaining and/or resuming the use of chronic sleep medications. If the patient has been unable to sleep, a hypnotic medication will be offered.
Other considerations include suggesting ventilatory support measures for selected patients.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patients with deep sedation that does not allow interaction with the evaluator;
* Moribund patients;
* Refusal to participate in the study.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Moinhos de Vento
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Laura Drehmer
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laura Drehmer
Role: PRINCIPAL_INVESTIGATOR
Vale dos Sinos Hospital
Felippe Dexheimer
Role: STUDY_DIRECTOR
Moinhos de Vento Hospital
Cassiano Teixeira
Role: STUDY_DIRECTOR
Moinhos de Vento Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Unimed Vale dos Sinos Hospital
Novo Hamburgo, Rio Grande do Sul, Brazil
Moinhos de Vento Hospital
Porto Alegre, Rio Grande do Sul, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Felippe Dexheimer
Role: CONTACT
References
Explore related publications, articles, or registry entries linked to this study.
Altman MT, Knauert MP, Pisani MA. Sleep Disturbance after Hospitalization and Critical Illness: A Systematic Review. Ann Am Thorac Soc. 2017 Sep;14(9):1457-1468. doi: 10.1513/AnnalsATS.201702-148SR.
Beltrami FG, John AB, de Macedo BR, Correa Junior V, Nguyen XL, Pichereau C, Maury E, Fleury B, Gus M, Fagondes SC. A multi-intervention protocol to improve sleep quality in a coronary care unit. Eur J Cardiovasc Nurs. 2022 Jun 30;21(5):464-472. doi: 10.1093/eurjcn/zvab099.
Ritmala-Castren M, Virtanen I, Vahlberg T, Leivo S, Kaukonen KM, Leino-Kilpi H. Evaluation of patients' sleep by nurses in an ICU. J Clin Nurs. 2016 Jun;25(11-12):1606-13. doi: 10.1111/jocn.13148. Epub 2016 Mar 18.
Ebben MR, Spielman AJ. Non-pharmacological treatments for insomnia. J Behav Med. 2009 Jun;32(3):244-54. doi: 10.1007/s10865-008-9198-8. Epub 2009 Jan 24.
Mori S, Takeda JR, Carrara FS, Cohrs CR, Zanei SS, Whitaker IY. Incidence and factors related to delirium in an intensive care unit. Rev Esc Enferm USP. 2016 Jul-Aug;50(4):587-593. doi: 10.1590/S0080-623420160000500007. English, Portuguese.
Richards KC, Wang YY, Jun J, Ye L. A Systematic Review of Sleep Measurement in Critically Ill Patients. Front Neurol. 2020 Nov 6;11:542529. doi: 10.3389/fneur.2020.542529. eCollection 2020.
Telias I, Wilcox ME. Sleep and Circadian Rhythm in Critical Illness. Crit Care. 2019 Mar 9;23(1):82. doi: 10.1186/s13054-019-2366-0.
Li SY, Wang TJ, Vivienne Wu SF, Liang SY, Tung HH. Efficacy of controlling night-time noise and activities to improve patients' sleep quality in a surgical intensive care unit. J Clin Nurs. 2011 Feb;20(3-4):396-407. doi: 10.1111/j.1365-2702.2010.03507.x.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
SPIRIT 2013 Checklist
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
842
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.