DeliriumLANYARD-ICUNCT06294158
Light and Noise: Objectively Assessing Environmental Risk Factors for Delirium in the ICU
An observational study of Delirium and Critical Illness, run by Medical University of Graz at 1 site in Austria.
Trial summary
Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in critically ill patients, is a relatively recent development. However, research into delirium prevention and treatment is now in focus of scientific efforts internationally. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Critical Illness
- What is being tested?
- Brightness measurement and Sound level measurement
- How many people
- 315 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2024to 30 Apr 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients shall be included into the study if they can be expected to remain in the ICU for at least another two days, if they are not yet in delirium, if the ICU environment is not actively modified for therapeutic reasons (e.g., in the treatment of burns patients), if no treatment limitations are in place and if the patient can provide written informed consent. In those patients, who cannot provide informed consent upon recruitment due to their current illness or injury, consent by patients or their representatives shall be sought if and once they regain capacity (deferred consent).
Who may be able to join
- Adult patients (age ≥ 18 years)
- Admission to participating Intensive Care Unit
- Expected (further) stay in participating Intensive Care Unit ≥ 48 hours
- Not (currently) deeply sedated (RASS ≥ -3) Exclusion Criteria
- Patient already in delirium (CAM-ICU positive)
- Environmental modification due to treatment necessities (e.g., burns care)
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- Advanced directives / Treatment limitation
- Current inclusion in other (interventional) trial
- Documented patient refusal in advance
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Austria1 site
University Medical Centre Graz, Dept. of Anaesthesiology and Intensive Care Medicine
Graz, Styria, 8036
About this study
Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in critically ill patients, is a relatively recent development. However, research into delirium prevention and treatment is now in focus of scientific efforts internationally.
Knowledge of intensive care unit (ICU) environment as a potential modifiable risk factor for delirium is insufficient to this date. This study thus seeks to evaluate, whether potentially modifiable environmental factors, such as noise or dazzling, are associated with development of delirium. Knowledge derived from this investigation could change both the process of care provision in intensive care units as well as the design of ICUs in general in the future.
Read more
This project is planned to be carried out as an observational pilot study at three perioperative ICUs at the University Medical Centre Graz. Adult patients shall be screened for inclusion, if not deeply sedated. Suitable patients shall be included into the study after written informed consent or deferred consent if they can be expected to remain in the ICU for at least another two days, if they are not already in delirium, if the ICU environment is not actively modified for therapeutic reasons and if no treatment limitations are in place. Over a study duration of one year, 250 to 300 patients are expected to be enrolled into the study. Of those, 60 to 120 patients are likely to develop delirium.
Baseline data known to be of relevance for outcome prediction in critically ill patients and factors known to predispose for development of delirium during ICU and hospital stay will be collected. Study equipment will be deployed to measure noise levels and illumination repeatedly over the day. Daily assessments for delirium using the Confusion Assessment Method in Intensive Care Units (CAM-ICU) will be performed. Vital status, physiologic parameters and parameters of ongoing treatment will concomitantly be documented on a daily basis.
Data on light and noise levels are then to be unified with parameters of physiology and treatment, vital status, and results of daily assessments for delirium. Statistical analysis using methods of descriptive and comparative statistics as well as both unadjusted and adjusted logistic regression analysis will be performed to identify factors significantly associated with the development of delirium (i.e., risk factors).
Read the detailed description
Delirium - derived from the word lira, Latin for furrow - literally means "to get off track". Historically, signs and symptoms of delirium have been taunted as "insanity". Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in in critically ill patients, is a relatively recent development. However, research into delirium, its prevention and treatment, is now in focus of scientific efforts by epidemiologic researchers and international societies alike.
Delirium now is a medical condition both recognised in current versions of the International Classification of Diseases (ICD-10) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). It is characterised by some disturbance in attention and awareness, acute onset and at least one additional disturbance in memory, orientation, language, visuospatial ability or perception, which cannot better be explained by another neurocognitive disorder and when there is evidence that the disturbances are a \"direct physiological consequence\" of another medical condition, substance intoxication or withdrawal, toxin, or various combinations of causes.
While historically sometimes regarded as an inalterable consequence of disease, delirium has been recognised as a significant contributor to both morbidity and even mortality in hospitalised patients, especially in critically ill individuals who require intensive care. Several risk factors for the development of delirium in intensive care units have been identified previously. However, many of these are factors not modifiable by caregivers (e.g., advanced age, frailty, pre-existing cognitive impairment, smoking, alcohol consumption, previous isolation, etc.) While some aspects of environment and interventions (especially endotracheal intubation, use of physical restraints and sedation with benzodiazepines, postoperative pain) have been found to be strongly associated with the development of delirium, assessment of the ICU environment itself as a potential modifiable risk factor is insufficient to this date.
Intensive care is known to be associated with high noise levels; attempts to reduce this noise pollution or provide protection from it may be worthwhile interventions to reduce delirium incidence. However, despite first attempts to establish associations between noise levels and delirium occurrence, no target values for possible future interventions have been established yet.
This study seeks to evaluate, whether potentially modifiable environmental factors in intensive care units, such as disturbances by noise or dazzling by light are associated with the development of delirium in critically ill patients. Knowledge derived from this investigation could change both the process of care provision in intensive care units as well as the design of ICUs in general in the future. Such changes could potentially improve outcomes, which would be much desired progress in delirium care, where both non-pharmacologic and pharmacologic therapeutic approaches have not convincingly been shown to be of benefit.
- Conditions
- Delirium, Critical Illness
- Being tested
- Brightness measurement, Sound level measurement
- Keywords
- Delirium, Critical Illness, Light, Noise
- Medical subject headings
- Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brightness measurementOther
Measurement of ambience brightness using lux meters
Sound level measurementOther
Measurement of ambience sound levels using sound level meters
| Study group | Role | What they receive |
|---|---|---|
| Observation Cohort | Adult patients (age ≥ 18 years) admitted to to participating Intensive Care Units with an expected (further) stay in participating Intensive Care Unit ≥ 48 hours who are not (currently) deeply sedated (RASS ≥ -3) and are not already in delirium (CAM-ICU positive), do not require environmental modification due to treatment necessities (e.g., burns care), and do not have advanced directives or treatment limitation orders in place, in whom environmental light and noise are measured. Receives: Other: Brightness measurement; Other: Sound level measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Development of delirium, i.e., positive CAM-ICU examination
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Oct 2024
- Primary completion31 Mar 2026
- Study completion30 Apr 2026
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 Medical University of GrazThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294158
- Sponsor's protocol ID
- LANYARD-ICU-1.1
- Acronym
- LANYARD-ICU
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light and Noise: Objectively Assessing Environmental Risk Factors for Delirium in the ICU
- ClinicalTrials.gov ID
- NCT06294158
- Acronym / sponsor ID
- LANYARD-ICU / LANYARD-ICU-1.1
- Conditions
- Delirium, Critical Illness
- Keywords
- Delirium, Critical Illness, Light, Noise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 5 Mar 2024 (actual)
- 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.
Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in critically ill patients, is a relatively recent development. However, research into delirium prevention and treatment is now in focus of scientific efforts internationally.
Knowledge of intensive care unit (ICU) environment as a potential modifiable risk factor for delirium is insufficient to this date. This study thus seeks to evaluate, whether potentially modifiable environmental factors, such as noise or dazzling, are associated with development of delirium. Knowledge derived from this investigation could change both the process of care provision in intensive care units as well as the design of ICUs in general in the future.
This project is planned to be carried out as an observational pilot study at three perioperative ICUs at the University Medical Centre Graz. Adult patients shall be screened for inclusion, if not deeply sedated. Suitable patients shall be included into the study after written informed consent or deferred consent if they can be expected to remain in the ICU for at least another two days, if they are not already in delirium, if the ICU environment is not actively modified for therapeutic reasons and if no treatment limitations are in place. Over a study duration of one year, 250 to 300 patients are expected to be enrolled into the study. Of those, 60 to 120 patients are likely to develop delirium.
Baseline data known to be of relevance for outcome prediction in critically ill patients and factors known to predispose for development of delirium during ICU and hospital stay will be collected. Study equipment will be deployed to measure noise levels and illumination repeatedly over the day. Daily assessments for delirium using the Confusion Assessment Method in Intensive Care Units (CAM-ICU) will be performed. Vital status, physiologic parameters and parameters of ongoing treatment will concomitantly be documented on a daily basis.
Data on light and noise levels are then to be unified with parameters of physiology and treatment, vital status, and results of daily assessments for delirium. Statistical analysis using methods of descriptive and comparative statistics as well as both unadjusted and adjusted logistic regression analysis will be performed to identify factors significantly associated with the development of delirium (i.e., risk factors).
Detailed description
Delirium - derived from the word lira, Latin for furrow - literally means "to get off track". Historically, signs and symptoms of delirium have been taunted as "insanity". Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in in critically ill patients, is a relatively recent development. However, research into delirium, its prevention and treatment, is now in focus of scientific efforts by epidemiologic researchers and international societies alike.
Delirium now is a medical condition both recognised in current versions of the International Classification of Diseases (ICD-10) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). It is characterised by some disturbance in attention and awareness, acute onset and at least one additional disturbance in memory, orientation, language, visuospatial ability or perception, which cannot better be explained by another neurocognitive disorder and when there is evidence that the disturbances are a \"direct physiological consequence\" of another medical condition, substance intoxication or withdrawal, toxin, or various combinations of causes.
While historically sometimes regarded as an inalterable consequence of disease, delirium has been recognised as a significant contributor to both morbidity and even mortality in hospitalised patients, especially in critically ill individuals who require intensive care. Several risk factors for the development of delirium in intensive care units have been identified previously. However, many of these are factors not modifiable by caregivers (e.g., advanced age, frailty, pre-existing cognitive impairment, smoking, alcohol consumption, previous isolation, etc.) While some aspects of environment and interventions (especially endotracheal intubation, use of physical restraints and sedation with benzodiazepines, postoperative pain) have been found to be strongly associated with the development of delirium, assessment of the ICU environment itself as a potential modifiable risk factor is insufficient to this date.
Intensive care is known to be associated with high noise levels; attempts to reduce this noise pollution or provide protection from it may be worthwhile interventions to reduce delirium incidence. However, despite first attempts to establish associations between noise levels and delirium occurrence, no target values for possible future interventions have been established yet.
This study seeks to evaluate, whether potentially modifiable environmental factors in intensive care units, such as disturbances by noise or dazzling by light are associated with the development of delirium in critically ill patients. Knowledge derived from this investigation could change both the process of care provision in intensive care units as well as the design of ICUs in general in the future. Such changes could potentially improve outcomes, which would be much desired progress in delirium care, where both non-pharmacologic and pharmacologic therapeutic approaches have not convincingly been shown to be of benefit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation Cohort | – | Other: Brightness measurement, Other: Sound level measurementAdult patients (age ≥ 18 years) admitted to to participating Intensive Care Units with an expected (further) stay in participating Intensive Care Unit ≥ 48 hours who are not (currently) deeply sedated (RASS ≥ -3) and are not already in delirium (CAM-ICU positive), do not require environmental modification due to treatment necessities (e.g., burns care), and do not have advanced directives or treatment limitation orders in place, in whom environmental light and noise are measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients shall be included into the study if they can be expected to remain in the ICU for at least another two days, if they are not yet in delirium, if the ICU environment is not actively modified for therapeutic reasons (e.g., in the treatment of burns patients), if no treatment limitations are in place and if the patient can provide written informed consent. In those patients, who cannot provide informed consent upon recruitment due to their current illness or injury, consent by patients or their representatives shall be sought if and once they regain capacity (deferred consent).
Key inclusion criteria (9 listed)
- Adult patients (age ≥ 18 years)
- Admission to participating Intensive Care Unit
- Expected (further) stay in participating Intensive Care Unit ≥ 48 hours
- Not (currently) deeply sedated (RASS ≥ -3) Exclusion Criteria
- Patient already in delirium (CAM-ICU positive)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Brightness measurementMeasurement of ambience brightness using lux meters | Other | Observation Cohort |
| Sound level measurementMeasurement of ambience sound levels using sound level meters | Other | Observation Cohort |
Primary outcome
Delirium
Time frame: 7 days
Development of delirium, i.e., positive CAM-ICU examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Critical Illness, run by Medical University of Graz at 1 site in Austria.
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 9 inclusion and 0 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: finished, as of the sponsor's last update on 10 Sep 2026. 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 Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Delirium (time frame: 7 days). 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 10 Sep 2026.