Dynamic Light Application to Prevent ICU Acquired Delirium (DLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01274819
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
K.S. Simons, Jeroen Bosch Ziekenhuis

Brief 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


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

Condition or disease Intervention/treatment Phase
Delirium Confusion Other: Dynamic Light Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dynamic Light Application to Prevent ICU Acquired Delirium
Study Start Date : July 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Dynamic light
ICU patients exposed to dynamic light during ICU stay
Other: Dynamic Light
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.
Other Name: Philips

No Intervention: Normal Light
control group is exposed to normal light during ICU stay

Primary Outcome Measures :
  1. delirium outcome [ Time Frame: duration of ICU stay(average duration 5 days) ]
    This is a composite endpoint of incidence of delirium during ICU stay, 28-day delirium free days (28-DFD) and 28-day ventilator free days (28-VFD)

Secondary Outcome Measures :
  1. ICU length-of-stay and ICU mortality [ Time Frame: duration of ICU stay, (average duration 5 days) ]
    ICU length-of-stay and ICU mortality

  2. duration of mechanical ventilation [ Time Frame: duration of ICU stay (average duration 5 days) ]
  3. Hospital length-of-stay and hospital mortality [ Time Frame: duration of hospital stay (average duration 14 days) ]
  4. serum levels of inflammatory markers and markers of brain damage [ Time Frame: duration of ICU stay (average duration 5 days) ]
    when patients are considered to be at high risk of developing ICU acquired delirium ( using a validated scoring system) blood samples will be drawn on days 1, 3, 5, 7, 14, 21, and 28 after inclusion in the study and stored at -80 degrees until analysis.

  5. urinary levels of markers of circadian rhythm [ Time Frame: duration of ICU stay (average duration 5 days) ]
    in a subgroup of long-stay ICU patients 3-hour urinary samples of cortisol and melatonin will taken during 24 hours to determine the circadian rhythm and the possible effect of DLA on this rhythm

  6. data of Health-related Quality of Life (HrQoL) questionnaires [ Time Frame: during ICU stay and 3, 6 and 12 months after ICU discharge ]
    3 and 6 months after ICU discharge, a validated HrQoL will be sent to patients homes to assess their QoL after the ICU stay and to detect differences between the DLA and reference group

  7. Delirium-free days without coma in 28 days [ Time Frame: 28 days ]
    To assess whether Dynamic Light not only influences incidence of delirium, but also duration of delirium, 28-day delirium free days without coma is used as a marker of duration of delirium. Patients who leave the ICU with a delirium (defined as a positive CAM-ICU score within 3 days of ICU discharge) will be followed on the wards using nurse charts and the delirium observation scale (DOS) to assess duration of delirium after ICU discharge

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ICU-patients >18 yrs old
  • expected duration of stay > 24 hrs

Exclusion Criteria:

  • life expectancy of <48 hrs on ICU admission
  • necessity of prolonged deep sedation
  • blindness
  • inability to speak or understand dutch

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01274819

Jeroen Bosch Hospital
Den bosch, Netherlands, 5211 nl
Sponsors and Collaborators
Jeroen Bosch Ziekenhuis
Principal Investigator: KS Simons, drs Jeroen Bosch Hospital


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: K.S. Simons, Drs, Jeroen Bosch Ziekenhuis Identifier: NCT01274819     History of Changes
Other Study ID Numbers: DLA 2011
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by K.S. Simons, Jeroen Bosch Ziekenhuis:

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders