Improving sleep quality and quantity in ICU patients through environmental control
Impact of the Use a Multifaceted Intervention of Environment Control in the ICU to Optimize Quantity and Quality of Sleep in Critically Ill Patients
This study tests if changing the light and noise levels in the ICU can help critically ill patients sleep better and recover faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago, Región Metropolitana) |
| Trial ID | NCT05694052 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on optimizing the sleep environment for critically ill patients in the ICU to address significant disturbances in sleep and circadian rhythms. The study implements a multifaceted approach to control environmental factors such as light and noise, which are known to disrupt sleep. By monitoring and adjusting these factors, the goal is to enhance both the quantity and quality of sleep for patients undergoing invasive mechanical ventilation. The study aims to evaluate the impact of these interventions on patient outcomes, including delirium and overall recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill patients who have been on invasive mechanical ventilation for at least 72 hours and are not heavily sedated.
Not a fit: Patients with pre-existing sleep disturbances or severe comorbidities that limit their life expectancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall recovery for critically ill patients in the ICU.
How similar studies have performed: While there have been limited studies on sleep optimization in the ICU, this multifaceted approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient under invasive mechanical ventilation for at least 72 hours. * Patient without sedation or with superficial sedation level (SAS 3-4 by Sedation- Agitation Scale), during most of the daytime within the 24 previous hours Exclusion Criteria: * Patient who required mechanical ventilation in another episode of hospitalization in the 2 months before screening. * Patients with primary neurological or neurosurgical disease. * Presence of mental or intellectual disability prior to hospitalization or communication/language barriers. * Pre-existing comorbidity with a life expectancy not exceeding 6 months (eg, metastatic cancer). * Readmission to the ICU (patients can only be included if they are on their first ICU admission of the present hospitalization). * No fixed address for follow-up. * Patients with moderate to severe visual or hearing impairment. * Patients with known sleep disturbance before hospital admission. * Early limitation of therapeutic effort.
Where this trial is running
Santiago, Región Metropolitana
- Hospital Clínico UC CHRISTUS — Santiago, Región Metropolitana, Chile (Recruiting)
Study contacts
- Study coordinator: Leyla M Alegría, MSc
- Email: lmalegri@uc.cl
- Phone: +56961703487
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.