CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,000 enrolled
Drug / intervention
Dynamic Lightother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01274819
NCT01274819N/ACompleted

Dynamic Light Application to Prevent ICU Acquired Delirium

Jeroen Bosch Ziekenhuis·interventional·Posted Jan 12, 2011·Updated Oct 16, 2013

In Brief

A clinical study evaluating Dynamic Light for Delirium and Confusion. Completed, enrolled 1,000 participants across 1 site.

Detailed Summary

Rationale: Delirium is a frequently encountered problem in ICU patients and leads to increased morbidity and mortality; Delirium in the ICU is associated with sleep deprivation which is among others caused by a disrupted circadian rhythm; Dynamic Light application aims at restoring a proper circadian rhythm by rhythmically alternating light intensity and has shown beneficial effects in sleep quality. Whether DLA improves sleep quality and reduces delirium incidence in ICU patients is not known Goals/endpoints: To evaluate the feasibility of dynamic light application in the ICU and to study the effects of dynamic light application on the incidence of delirium, duration of mechanical ventilation, the number of ICU and hospital days, and mortality in a mixed population of medical and surgical ICU patients. In a subgroup of patients with a high risk of developing delirium, markers of circadian rhythm, inflammation and brain damage and post ICU HRQoL will be assessed Study design: prospective randomized single centre trial Study population: adult ICU patients \> 18 years old with an expected duration of stay of more than 24 hours Intervention: Patients will be randomized between Standard Care or Standard Care + DLA; When receiving standard care, normal lighting settings will be used in that patient room, which can be controlled by the medical personnel; In the rooms of patients randomized to the DLA group, DL is applied with a changing intensity during the day according to a fixed rhythm, which is regulated centrally. In addition when necessary, an intervention light can be used which can be operated in the patient room. Study parameters/endpoints: incidence of delirium as measured by the CAM-ICU; duration of mechanical ventilation, ICU and total hospital mortality; ICU and hospital LOS; Serum levels of inflammatory markers and markers of brain damage, urinary levels of markers of circadian rhythm, data of HRQoL questionnaires and total light exposure in both groups

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelirium, Confusion
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 12, 2011
Enrollment StartJul 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.5 years ago

Interventions

Dynamic Lightother

Dynamic Light Application (DLA) is a light application which exposes the subject in the room to a varying light intensity and light temperature during the day thus mimicking a natural daylight exposure.