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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Austria

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.

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 groups in NCT06294158
Study groupRoleWhat they receive
Observation CohortAdult 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.

  1. 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.

  1. First posted5 Mar 2024
  2. Study start1 Oct 2024
  3. Primary completion31 Mar 2026
  4. Study completion30 Apr 2026

Resources

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)
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

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.

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