DeliriumNCT01343433
Influence of Light Therapy on Confusion in Patients at the Intensive Care Unit
An observational study of Delirium and Intensive Care Unit Syndrome, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
Trial summary
Our purpose of this study is to determine whether bright light therapy is effective for reducing the incidence and the duration of delirium compared to the usual treatment in patients at the Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Intensive Care Unit Syndrome
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2011to May 2011
- Phase
- Observational
- 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
Study population: All patients of 18 years and older who will be admitted to the Intensive Care Unit of the Onze Lieve Vrouwe Gasthuis, Amsterdam can be included in the study. This is a medical surgical level three ICU with 24 beds. There are over 90 specialised ICU nurses laborious in this ICU. An average of 1500 patients a year is admitted, of which 750 from the cardiothoracic surgical department.
Who may be able to join
- Age: a minimum age of 18 years
Who cannot join
- Psychiatric comorbidity: bipolar disorder
- The use of an antipsychotic drug in the home environment
- Participation in this study during a previous admission to the ICU
- Temporary or permanent loss of total vision
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1090 HM
J I van der Spoel, MD, 003120-5993007, j.i.vanderspoel@olvg.nl
J.I van der Spoel, MD
About this study
Official title: Influence of Bright Light Therapy on Delirium in Patients at the Intensive Care Unit: a Pilot-study
Our purpose of this study is to determine whether bright light therapy is effective for reducing the incidence and the duration of delirium compared to the usual treatment in patients at the Intensive Care Unit. Our hypothesis is that bright light therapy is effective for reducing the incidence and duration of delirium in patients at the Intensive Care Unit
Patients will be assigned to a chamber with or without bright light therapy. This assignment is based on occupation of ICU beds and availability of nurses and is therefore independent from patients characteristics. Patients will be included following the inclusion criterion and exclusion criteria. Patients assigned to a chamber with bright light therapy will receive light therapy for three hours in the morning, from eight o'clock till eleven o'clock. The Confusion Assessment Method-score (CAM-score) and the Richmond Agitation Sedation Scale-score (RASS-score) will be performed three times at one day by ICU nurses, this is according to the existing routine. Besides this, an extra CAM-score and a clinical assessment will be performed once a day by a trained non-clinician, to determine the presence of delirium. The use of sedatives, haldol and fixation will be registered to determine the occurrence, duration and severity of delirium. Eventually the most important outcomes will be the clinical assessment of the patients, the CAM-score and the use of haldol. The primary outcome of this study is the duration of delirium, defined in number of days.
Read the detailed description
Intensive Care patients experience severe alterations of sleep. They may develop a circadian rhythm sleep disorder, characterized by an irregular sleep/wake pattern. The presence of abnormal sleep/wake cycles may be a risk factor for delirium, which would link it to higher morbidity, mortality and longer ICU stay. Bright light therapy is the treatment of choice for circadian rhythm sleep disorders and may be helpful in handling delirium. The objective of this study is to determine whether bright light therapy is effective for reducing the incidence and duration of delirium in the Intensive Care Unit.
This is a prospective, single center cohort investigation by witch the influence of bright light therapy on the incidence and duration of delirium will be examined and compared with environmental light. This study will take place at the ICU of the OLVG, a level three ICU with 24 beds in a teaching hospital.
Patients will be assigned to a chamber with or without bright light therapy. This assignment is based on occupation of ICU beds and availability of nurses and is therefore independent from patients characteristics. All patients of 18 years and older who will be admitted to the Intensive Care Unit of the Onze Lieve Vrouwe Gasthuis, Amsterdam can be included in the study. Patients diagnosed with bipolar disorder will be excluded from participation. Other exclusion criteria are the use of an antipsychotic drug in the home environment, temporary or permanent loss of total vision and participation in this study during a previous admission to the Intensive Care Unit.
Patients assigned to a chamber with bright light therapy will receive light therapy for three hours in the morning, from eight o'clock till eleven o'clock. The Confusion Assessment Method-score (CAM-score) and the Richmond Agitation Sedation Scale-score (RASS-score) will be performed three times at one day by ICU nurses, this is according to the existing routine. Besides this, an extra CAM-score and a clinical assessment will be performed once a day by a trained non-clinician, to determine the presence of delirium. The use of sedatives, haldol and fixation will be registered to determine the occurrence, duration and severity of delirium. Eventually the most important outcomes will be the clinical assessment of the patients, the CAM-score and the use of haldol.
At the Intensive Care Unit of the Onze Lieve Vrouwe Gasthuis, Amsterdam, light therapy is used by nurses for optimizing the light intensity in their work environment, for their own well being and for the prevention of sleep disturbances. The light therapy is also randomly used for the treatment of Intensive Care patients, though the effectiveness and functionality have not been a subject of investigation. Our purpose of this study is to determine whether bright light therapy is effective for reducing the incidence and the duration of delirium in the Intensive Care Unit. The primary outcome of this study is the duration of delirium, defined in number of days. This will be derived from the clinical assessments and the CAM-scores, performed by the trained non-clinician.
- Conditions
- Delirium, Intensive Care Unit Syndrome
- Keywords
- Delirium, Intensive Care Unit Syndrome, Bright light therapy, Intensive Care Unit
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Chamber allocation will determine which patient receives bright light therapy. We selected four patient chambers at the Intensive Care Unit, each with the capacity of two patient beds. In two chambers patients will receive bright light therapy. Patients in the other two rooms are only exposed to environmental light | |
| Treatment group (bright light therapy) | Chamber allocation will determine which patient receives bright light therapy. We selected four patient chambers at the Intensive Care Unit, each with the capacity of two patient beds. In two chambers patients will receive bright light therapy. During our study, light therapy will be applied with instrument 'Litepod' (manufactured by Goodlite, Donker Curtiusstraat 7/407, Amsterdam), which gives an intensity of 10000 lux at a distance of 22 centimetres.Patients will receive bright light therapy for three hours in the morning, from eight o'clock till eleven o'clock. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of delirium, defined in days
The primary outcome of this study will be the duration of delirium, defined in number of days. This will be derived from the clinical assessments and CAM-scores, performed by the trained non-clinician.
Measured: After 10 weeks
Secondary outcomes (8)
Incidence of delirium in the patient group receiving bright light therapy and in the group receiving environmental light
Measured: After 10 weeks
CAM-scores of the ICU nurses
The Confusion Assessment Method-ICU is the most accurate diagnostic instrument to detect delirium in hospitalized patients and is the only instrument validated for detecting delirium in mechanically ventilated patients. These scores are already determined three times at one day by Intensive Care nurses.
Measured: After 10 weeks
Dosage of haloperidol use in delirious patients receiving bright light therapy and those receiving environmental light
The dosage of haldol use will be registered to determine the presence and duration of delirium
Measured: After 10 weeks
Duration of haldol use in delirious patients receiving bright light therapy and those receiving environmental light
The duration of haldol use will be registered to determine the presence and duration of delirium
Measured: After 10 weeks
Mortality of delirious patients in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light
We are interested in variables that could be influenced by the presence of delirium, including mortality.
Measured: After 10 weeks
Duration of mechanical ventilation in delirious patients receiving bright light therapy and those receiving environmental light
We are interested in variables that could be influenced by the presence of delirium, including duration of mechanical ventilation
Measured: After 10 weeks
Duration of admission of delirious patients in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light
We are interested in variables that could be influenced by the presence of delirium, including the duration of admission
Measured: After 10 weeks
Duration of admission in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light
We are interested in variables that could be influenced by the presence of delirium, including the duration of admission
Measured: After 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Investigators
- J.I van der Spoel, MD, Principal investigator, Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343433
- Sponsor's protocol ID
- D-3101-4
- Status last verified
- Apr 2011
- First submitted
- 25 Apr 2011
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Bright Light Therapy on Delirium in Patients at the Intensive Care Unit: a Pilot-study
- ClinicalTrials.gov ID
- NCT01343433
- Acronym / sponsor ID
- D-3101-4
- Conditions
- Delirium, Intensive Care Unit Syndrome
- Keywords
- Delirium, Intensive Care Unit Syndrome, Bright light therapy, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 28 Apr 2011 (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.
Our purpose of this study is to determine whether bright light therapy is effective for reducing the incidence and the duration of delirium compared to the usual treatment in patients at the Intensive Care Unit. Our hypothesis is that bright light therapy is effective for reducing the incidence and duration of delirium in patients at the Intensive Care Unit
Patients will be assigned to a chamber with or without bright light therapy. This assignment is based on occupation of ICU beds and availability of nurses and is therefore independent from patients characteristics. Patients will be included following the inclusion criterion and exclusion criteria. Patients assigned to a chamber with bright light therapy will receive light therapy for three hours in the morning, from eight o'clock till eleven o'clock. The Confusion Assessment Method-score (CAM-score) and the Richmond Agitation Sedation Scale-score (RASS-score) will be performed three times at one day by ICU nurses, this is according to the existing routine. Besides this, an extra CAM-score and a clinical assessment will be performed once a day by a trained non-clinician, to determine the presence of delirium. The use of sedatives, haldol and fixation will be registered to determine the occurrence, duration and severity of delirium. Eventually the most important outcomes will be the clinical assessment of the patients, the CAM-score and the use of haldol. The primary outcome of this study is the duration of delirium, defined in number of days.
Detailed description
Intensive Care patients experience severe alterations of sleep. They may develop a circadian rhythm sleep disorder, characterized by an irregular sleep/wake pattern. The presence of abnormal sleep/wake cycles may be a risk factor for delirium, which would link it to higher morbidity, mortality and longer ICU stay. Bright light therapy is the treatment of choice for circadian rhythm sleep disorders and may be helpful in handling delirium. The objective of this study is to determine whether bright light therapy is effective for reducing the incidence and duration of delirium in the Intensive Care Unit.
This is a prospective, single center cohort investigation by witch the influence of bright light therapy on the incidence and duration of delirium will be examined and compared with environmental light. This study will take place at the ICU of the OLVG, a level three ICU with 24 beds in a teaching hospital.
Patients will be assigned to a chamber with or without bright light therapy. This assignment is based on occupation of ICU beds and availability of nurses and is therefore independent from patients characteristics. All patients of 18 years and older who will be admitted to the Intensive Care Unit of the Onze Lieve Vrouwe Gasthuis, Amsterdam can be included in the study. Patients diagnosed with bipolar disorder will be excluded from participation. Other exclusion criteria are the use of an antipsychotic drug in the home environment, temporary or permanent loss of total vision and participation in this study during a previous admission to the Intensive Care Unit.
Patients assigned to a chamber with bright light therapy will receive light therapy for three hours in the morning, from eight o'clock till eleven o'clock. The Confusion Assessment Method-score (CAM-score) and the Richmond Agitation Sedation Scale-score (RASS-score) will be performed three times at one day by ICU nurses, this is according to the existing routine. Besides this, an extra CAM-score and a clinical assessment will be performed once a day by a trained non-clinician, to determine the presence of delirium. The use of sedatives, haldol and fixation will be registered to determine the occurrence, duration and severity of delirium. Eventually the most important outcomes will be the clinical assessment of the patients, the CAM-score and the use of haldol.
At the Intensive Care Unit of the Onze Lieve Vrouwe Gasthuis, Amsterdam, light therapy is used by nurses for optimizing the light intensity in their work environment, for their own well being and for the prevention of sleep disturbances. The light therapy is also randomly used for the treatment of Intensive Care patients, though the effectiveness and functionality have not been a subject of investigation. Our purpose of this study is to determine whether bright light therapy is effective for reducing the incidence and the duration of delirium in the Intensive Care Unit. The primary outcome of this study is the duration of delirium, defined in number of days. This will be derived from the clinical assessments and the CAM-scores, performed by the trained non-clinician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Chamber allocation will determine which patient receives bright light therapy. We selected four patient chambers at the Intensive Care Unit, each with the capacity of two patient beds. In two chambers patients will receive bright light therapy. Patients in the other two rooms are only exposed to environmental light |
| Treatment group (bright light therapy) | – | –Chamber allocation will determine which patient receives bright light therapy. We selected four patient chambers at the Intensive Care Unit, each with the capacity of two patient beds. In two chambers patients will receive bright light therapy. During our study, light therapy will be applied with instrument 'Litepod' (manufactured by Goodlite, Donker Curtiusstraat 7/407, Amsterdam), which gives an intensity of 10000 lux at a distance of 22 centimetres.Patients will receive bright light therapy for three hours in the morning, from eight o'clock till eleven o'clock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of 18 years and older who will be admitted to the Intensive Care Unit of the Onze Lieve Vrouwe Gasthuis, Amsterdam can be included in the study. This is a medical surgical level three ICU with 24 beds. There are over 90 specialised ICU nurses laborious in this ICU. An average of 1500 patients a year is admitted, of which 750 from the cardiothoracic surgical department.
Key inclusion criteria (1 listed)
- Age: a minimum age of 18 years
Key exclusion criteria (4 listed)
- Psychiatric comorbidity: bipolar disorder
- The use of an antipsychotic drug in the home environment
- Participation in this study during a previous admission to the ICU
- Temporary or permanent loss of total vision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of delirium, defined in days
Time frame: After 10 weeks
The primary outcome of this study will be the duration of delirium, defined in number of days. This will be derived from the clinical assessments and CAM-scores, performed by the trained non-clinician.
8 secondary outcomes
Incidence of delirium in the patient group receiving bright light therapy and in the group receiving environmental light
Time frame: After 10 weeks
CAM-scores of the ICU nurses
Time frame: After 10 weeks
Dosage of haloperidol use in delirious patients receiving bright light therapy and those receiving environmental light
Time frame: After 10 weeks
Duration of haldol use in delirious patients receiving bright light therapy and those receiving environmental light
Time frame: After 10 weeks
Mortality of delirious patients in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light
Time frame: After 10 weeks
Duration of mechanical ventilation in delirious patients receiving bright light therapy and those receiving environmental light
Time frame: After 10 weeks
Duration of admission of delirious patients in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light
Time frame: After 10 weeks
Duration of admission in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light
Time frame: After 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
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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.
J.I van der Spoel, MD principal investigator
Onze Lieve Vrouwe Gasthuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Intensive Care Unit Syndrome, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Apr 2011. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact J.I van der Spoel (003120-5993007, j.i.vanderspoel@olvg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of delirium, defined in days (time frame: After 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2011.