Impact of a Multifaceted Intervention of Environment Control in the ICU to Optimize Quantity and Quality of Sleep

NCT05694052 | Completed

• 2 other identifiers: 1905280021201772
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

In critically ill patients, sleep and circadian rhythms are markedly disturbed, including sleep deprivation and disruption, as well as altered sleep architecture, and loss of normal oscillations of Melatonin and Cortisol. These alterations have been associated with delirium, fatigue, and higher mortality. In addition, sleep disturbances may remain after hospital discharge, and they have been associated with psychological comorbidities, which may contribute to the low quality of life observed in ICU survivors. Patient factors for sleep deprivation in ICU are the type/severity of underlying illness, the pathophysiology of the acute illness, pain, and stress/anxiety. Factors associated with the ICU, such as exposure to inadequate levels of light and noise, or inflexible schedules of daily care activities, have also been reported to have a major role in sleep disturbance. A limited number of studies have evaluated interventions targeting sleep optimization in the ICU, using strategies like eye masks and/or earplugs to isolate patients from their environment, the application of a dynamic light system that ensures light at night and higher levels of light at daytime to restore circadian rhythm, or auditory masking, to avoid intense cortical stimuli secondary to annoying noises. These strategies have been reported to have some positive impacts on sleep in ICU but this has only been assessed by qualitative instruments. In addition, they have been tested as isolated interventions, and not as part of a more comprehensive approach. The goal of this project is to determine the impact of a multifaceted intervention of environmental control in the ICU, based on dynamic light therapy, auditory masking, and rationalization of ICU nocturnal patient care activities, on quantity and quality of sleep, assessed by polysomnography and other semi-quantitative methods, compared to standard care. In addition, the effect of both strategies on delirium, circadian rhythm biomarkers, and long-term neuropsychological outcomes will be compared. This is a prospective, parallel-group, randomized trial in 56 critically ill patients once they are starting to recover from their acute illness. After obtaining informed consent, patients will be randomized to receive a multifaceted intervention of environmental control or standard care. And this protocol will be applied from enrollment until ICU discharge, with a follow-up before hospital discharge and at 6 months.

Conditions

Sleep Disturbance

Keywords

ICU; Environment control; Critically ill patients; Adult; Multifaceted intervention

Outcome Measures

Primary Outcomes (1)

• Minutes in slow-wave sleep-N3

  Minutes in slow-wave sleep-N3 evaluated by Polysomnography.

  Night 3 from enrollment.

Secondary Outcomes (9)

• Minutes of rapid eye movement sleep

  Night 3 from enrollment.

• Total sleep time

  From the first day after randomization, assessed up 1 week after ICU discharge.

• Change in Richards-Campbell Sleep Questionnaire (RCSQ) score

  From the second day of enrollment until discharge from ICU, assessed up to day 28.

• Change in Pittsburgh Sleep Quality Index (PSQI) score

  From the second day of enrollment until discharge from ICU, assessed up to day 28.

• Circadian rhythm

  Melatonin and cortisol plasmatic levels will be assessed at the day 1 and 3 after randomization.

Study Arms (2)

Multifaceted Intervention

EXPERIMENTAL

Lighting: a multi-channel LED Spectrum will be implemented. The spectral output covers the wavelength range from 420 nm to 730 nm. All active channels are mixed, providing a smooth (uniform in color) light with a Lambertian pattern profile. Noise: the auditory masking system will provide a continuous background digitally generated broadband pink noise. The sound system will be placed near the head of the bed. This will be started (at 62 DB sound level) each night for 8 hours. Nocturnal patient care activities: night-time patient care activities will be re-organized to minimize interruptions. The medication administration schedule will be organized, and the vital signs monitoring will be done continuously by medical devices without requiring to disturb the patient. Hygiene, comfort, and elective activities will be scheduled for the daytime. Emergency interventions will not be limited.

Behavioral: Multifaceted Intervention of environment control

Standard Care

NO INTERVENTION

Lighting: standard lighting system currently installed in the ICU rooms provides a fix light of 300 to 400 lux during daytime, and 0 to 30 lux during night-time. Controls depends on staff to switched on and off. Noise: The rooms do not have noise isolation and there is no protocol for reducing environmental noise. In our ICU, isolated measurements reported mean average values of 60 dB during daytime and 50 dB during nighttime, with frequent peaks over 80 to 90 dB. Nocturnal patient care activities: There is no specific protocol for patient care activities during the night. The activities (schedules of drug administration and intravenous infusions, non-urgent examinations, and non-urgent procedures) are organized during the morning by the patient's nurse according to their own clinical criteria. Hygiene and comfort activities are carried out in standard schedules according to the rules of the ICU. Drug administration, examinations and urgent procedures are performed when necessary.

Interventions

Multifaceted Intervention of environment control BEHAVIORAL

Dynamic light therapy, auditory masking, and rationalization of ICU nocturnal patient activities.

Multifaceted Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Agencia Nacional de Investigacion y Desarrollo, ANID: collaborator

Study Sites (1)

Hospital Clínico UC CHRISTUS

Santiago, Santiago Metropolitan, 8330024, Chile

Location

Related Publications (1)

• Alegria L, Brockmann P, Repetto P, Leonard D, Cadiz R, Paredes F, Rojas I, Moya A, Oviedo V, Garcia P, Bakker J. Improve sleep in critically ill patients: Study protocol for a randomized controlled trial for a multi-component intervention of environment control in the ICU. PLoS One. 2023 May 25;18(5):e0286180. doi: 10.1371/journal.pone.0286180. eCollection 2023.

  PMID: 37228142 DERIVED

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Alejandro R Bruhn, PhD

  Pontificia Universidad Catolica de Chile

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the type of intervention under study, the patient and the research team can not be blinded to the group assignment. Statisticians and the researchers responsible for analysis of PSG and actigraphy, as well as those performing long-term outcome assessments, will be blinded to the group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, parallel-group, randomized trial in critically ill patients. The project will follow the CONSORT guidelines for this class of studies. Patients randomized sequence will be generated by a computer program with an allocation 1:1. They will be randomized to receive a multifaceted intervention of environmental control in the ICU (intervention group) or standard care (control group).

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: January 23, 2023
• Study Start: May 2, 2023
• Primary Completion: January 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 2, 2025

Record last verified: 2024-08

Locations

CL (1)