DeliriumPreDeLight-ICUNCT01727375

Prevention of Delirium With Light in the Intensive Care Unit

A study testing Circadian light in people with Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this multicenter randomised controlled trial is to investigate if circadian light at the patients bedside (using Philips HealWell system, CE marked)significantly reduces prevalence of delirium in mechanically ventilated intensive care unit patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Delirium
What is being tested?: Circadian light
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteGermany
Study dates: Jul 2013to Nov 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients with age 18 years and above
Intensive Care Unit stay ≥ 48 hours
Invasive mechanical ventilation or not invasive mechanical ventilation (with positive ventilation pressure >6hours/day and highflow >30 litres) on the day of Intensive Care Unit admission

Who cannot join

Patients with a history Intensive Care Unit stay during the actual hospital stay
Patients with delirium on the day of Intensive Care Unit admission
Patients with psychiatric diseases
Patients with a history of stroke and known cognitive dysfunctions
Participation in other clinical studies 10 days before study inclusion and during the study period
Psychiatric disease

Show all 16Show fewer

History of stroke with known residual cognitive deficits
History of Asystolia or pulseless electric activity with cardiopulmonary resuscitation during entire hospital stay
Analphabetism
Unability of German language use
Anacusis or Hypoacusis with hearing aid device, Amaurosis
Allergies to any ingredient of the electrode fixing material
Lacking willingness to save and hand out data within the study
Accommodation in an institution due to an official or judicial order
The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial

Trial locations and contacts

1 site in 1 country.

Germany1 site

Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin
Berlin, State of Berlin, 10117

Other trials in Germany

About this study

Read the detailed description

Patients, who are randomly assigned to the "Lightening arm" will have the circadian light for the whole ICU stay. Light levels at the patients bedside will be measured continuously: embedded light sensors provide irradiance and luminous lux recordings in red, green, and blue color bands and a white light measurement in lux

Conditions: Delirium
Being tested: Circadian light
Keywords: delirium, light, ICU, sleep
Medical subject headings: Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Circadian lightOther
Artificial ceiling lighting throughout the day will be provided by the Philips HealWell system, CE marked, which is able to deliver varying light levels and warmer or cooler light according to the time of the day (circadian light). Emergency or examination lighting can be set on demand as circumstances require.
Lighting conditions at the patients bedside will be characterized by transformations on the time-series of light levels as measured by a luxmeter. The following metrics will be used for lighting characterization in a period of 24h: mean levels of bright and dark periods, contrast between bright and dark periods, clustering of bright and dark periods, and circadian variation.

Study groups in NCT01727375
Study group	Role	What they receive
Standard light	No intervention	In this arm patients receive standard lightening conditions
Ciradian light	Experimental	In this arm patients receive artificial ceiling light (circadian light) at the bedside. Receives: Other: Circadian light

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of delirium
Dekirium will be measured with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days

Secondary outcomes (21)

Delirium prevalence
In this case, delirium will be measured with the help of the Intensive care Delirium Screening Checklist (ICDSC)
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Severity of delirium
Severity of delirium will be measured with the help of the Intensive Care Delirium Screening Checklist (ICDSC)
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Duration of delirium
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Prevalence of subsyndromal delirium (SSD)
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Severity of anxiety
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Cognitive Dysfunction
Measured: ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge
Post-Traumatic Stress Disorder (PTSD)
Measured: 6 and 12 months after hospital discharge
Sleep quality
Measured: In the night, starting 48 hours after ICU admission
ICU length of stay
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Duration of mechanical ventilation
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Hospital length of stay
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks
Level of sedation
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Pain level
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Amount of administered opioids
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Amount of administered benzodiazepines
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Amount of administered sedatives
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Amount of administered antipsychotics
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Mortality
Measured: ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge
Light levels (lux) Light levels (lux)
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Light frequencies
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Noise levels (decibel)
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Nov 2016

First posted16 Nov 2012 (estimated)
Study startJul 2013
Primary completionNov 2016 (estimated)
Study completionNov 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DeliriumStudies of the same condition, open and under way.
More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01727375
Sponsor's protocol ID: PreDeLight-ICU
Acronym: PreDeLight-ICU
Status last verified: Oct 2015
First submitted: 4 Jul 2012
Last updated: 19 Oct 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer

All Delirium trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Delirium With Light in the Intensive Care Unit
ClinicalTrials.gov ID: NCT01727375
Acronym / sponsor ID: PreDeLight-ICU / PreDeLight-ICU
Conditions: Delirium
Keywords: delirium, light, ICU, sleep
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Charite University, Berlin, GermanyUniversity, hospital or other
Study start: Jul 2013
Primary completion: Nov 2016 (estimated)
Study completion: Nov 2016 (estimated)
First posted: 16 Nov 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard light	No intervention	–In this arm patients receive standard lightening conditions
Ciradian light	Experimental	Other: Circadian lightIn this arm patients receive artificial ceiling light (circadian light) at the bedside.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male and female patients with age 18 years and above
Intensive Care Unit stay ≥ 48 hours
Invasive mechanical ventilation or not invasive mechanical ventilation (with positive ventilation pressure >6hours/day and highflow >30 litres) on the day of Intensive Care Unit admission

Key exclusion criteria (16 listed)

Patients with a history Intensive Care Unit stay during the actual hospital stay
Patients with delirium on the day of Intensive Care Unit admission
Patients with psychiatric diseases
Patients with a history of stroke and known cognitive dysfunctions
Participation in other clinical studies 10 days before study inclusion and during the study period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Circadian lightArtificial ceiling lighting throughout the day will be provided by the Philips HealWell system, CE marked, which is able to deliver varying light levels and warmer or cooler light according to the time of the day (circadian light). Emergency or examination lighting can be set on demand as circumstances require. Lighting conditions at the patients bedside will be characterized by transformations on the time-series of light levels as measured by a luxmeter. The following metrics will be used for lighting characterization in a period of 24h: mean levels of bright and dark periods, contrast between bright and dark periods, clustering of bright and dark periods, and circadian variation.	Other	Ciradian light

Primary outcome

Prevalence of delirium
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Dekirium will be measured with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

21 secondary outcomes

Delirium prevalence
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Severity of delirium
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Duration of delirium
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Prevalence of subsyndromal delirium (SSD)
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Severity of anxiety
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Cognitive Dysfunction
Time frame: ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge
Post-Traumatic Stress Disorder (PTSD)
Time frame: 6 and 12 months after hospital discharge
Sleep quality
Time frame: In the night, starting 48 hours after ICU admission
ICU length of stay
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Duration of mechanical ventilation
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Hospital length of stay
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks
Level of sedation
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Pain level
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Amount of administered opioids
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Amount of administered benzodiazepines
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Amount of administered sedatives
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Amount of administered antipsychotics
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Mortality
Time frame: ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge
Light levels (lux) Light levels (lux)
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Light frequencies
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Noise levels (decibel)
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.

Related trials for Delirium

RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Claudia Spies, MD, Prof. study director

Dept. of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - Universitaetsmedizin Berlin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Circadian light in people with Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of delirium (time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01727375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.