Intensive Care Unit DeliriumNCT05950958
Prevention of Delirium in ICU Using Multimodal Interventions
A study testing Multimodal therapy for prevention of delirium in people with Intensive Care Unit Delirium, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study was designed to evaluate the impact of non-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Intensive Care Unit Delirium
- What is being tested?
- Multimodal therapy for prevention of delirium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2022to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 50 years who are expected to spend more than 24 hours in the intensive care unit
Who cannot join
- Patients who developed delirium before entering the intensive care unit
- Patients with cognitive impairment
- Patients who have hearing or vision deficits, or have difficulty in communication
- Patients who are expected to die within 24 hours or do not want life-sustaining treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Ho Geol Ryu, MD, PhD, +82-2072-2065, hogeol@gmail.com
Seung-Young Oh, MD, MS, +82-2072-3098, faun1226@gmail.com
About this study
Official title: The Impact of Audio and Visual Intervention in Preventing ICU Delirium in Critically Ill Patients : A Randomized Clinical Trial
This study was designed to evaluate the impact of non-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit.
Read the detailed description
Delirium significantly increases not only the length of the intensive care unit stay and overall mortality, but also the likelihood of persistant cognitive impairment after recovery. However there is no definitive treatment for delirium, thereby it is important to prevent delirium before it occur. Researches also have focused on the prevention of delirium or the reduction of duration of delirium.
Several studies evaluated the effect of non-pharmacological treatment, such as improvement of orientation, prevention of sensory deprivation, active pain control and prevention of dehydration, to reduce the occurrence of delirium and the results were inconsistent depending on the patients included. However, there have been no randomized clinical trials that have tested the effect of prevention of delirium by applying non-pharmacological multimodal approaches in the intensive care unit for Korean patients.
A randomized controlled trial was planned to evaluate the impact of on-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit in Korea.
- Conditions
- Intensive Care Unit Delirium
- Being tested
- Multimodal therapy for prevention of delirium
- Keywords
- Delirium, Intensive Care Unit, Non-pharmacological intervention
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal therapy for prevention of deliriumOther
Multimodal therapy for prevention of delirium
| Study group | Role | What they receive |
|---|---|---|
| Multimodal therapy group | Experimental | Continuous regional cerebral oxygen saturation and processed electroencephalogram (EEG) are monitored.
Multimodal therapy with conventional care are provided to prevent delirium. Ongoing orientation: 3 times per day Sensory correction: the hearing device and the glasses are supplied. Cognitive stimulation: a portable monitor is used to provide visual stimulation, and a directional speaker is used to avoid disturbing the alarm of the patient's life supportimng system.
Sleep promotion: the lights are turned off from 10 pm to 7 am, and the indirect light source is used if necessary. Receives: Other: Multimodal therapy for prevention of delirium |
| Conventional care group | No intervention | Continuous regional cerebral oxygen saturation and processed electroencephalogram (EEG) are monitored. Conventional care: If sedation is required, dexmedetomidine is considered as the first-line sedative drug. The sedation is interrupted daily and the possibility of awakening is assessed. Pain with NRS score above 3, is controlled with opioid. For patients with Richmond Agitation Sedation Scale (RASS) -4 or -5, possible items are provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with delirium
Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)
Measured: From ICU admission up to day 28 or discharge from ICU or death
Secondary outcomes (4)
Delirium-free days
Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)
Measured: From ICU admission up to day 28 or discharge from ICU or death
Severity of delirium
Confusion Assessment Method for the ICU-7 (CAM-ICU-7) delirium severity score
Measured: From ICU admission up to day 28 or discharge from ICU or death
Accidental extubation or disconnection of treatment devices
Accidental extubation or disconnection of treatment devices
Measured: From ICU admission up to day 28 or discharge from ICU or death
ICU and hospital length of stay
Duration of ICU and hospital stay
Measured: From ICU admission up to day 28 or discharge from ICU or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Aug 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit DeliriumStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Geol Ryu, Seoul National University Hospital
- Investigators
- Ho Geol Ryu, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950958
- Sponsor's protocol ID
- Delirium_ICU
- Status last verified
- May 2026
- First submitted
- 28 Jul 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Audio and Visual Intervention in Preventing ICU Delirium in Critically Ill Patients : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05950958
- Acronym / sponsor ID
- Delirium_ICU
- Conditions
- Intensive Care Unit Delirium
- Keywords
- Delirium, Intensive Care Unit, Non-pharmacological intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 18 Jul 2023 (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.
This study was designed to evaluate the impact of non-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit.
Detailed description
Delirium significantly increases not only the length of the intensive care unit stay and overall mortality, but also the likelihood of persistant cognitive impairment after recovery. However there is no definitive treatment for delirium, thereby it is important to prevent delirium before it occur. Researches also have focused on the prevention of delirium or the reduction of duration of delirium.
Several studies evaluated the effect of non-pharmacological treatment, such as improvement of orientation, prevention of sensory deprivation, active pain control and prevention of dehydration, to reduce the occurrence of delirium and the results were inconsistent depending on the patients included. However, there have been no randomized clinical trials that have tested the effect of prevention of delirium by applying non-pharmacological multimodal approaches in the intensive care unit for Korean patients.
A randomized controlled trial was planned to evaluate the impact of on-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit in Korea.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal therapy group | Experimental | Other: Multimodal therapy for prevention of deliriumContinuous regional cerebral oxygen saturation and processed electroencephalogram (EEG) are monitored. Multimodal therapy with conventional care are provided to prevent delirium. Ongoing orientation: 3 times per day Sensory correction: the hearing device and the glasses are supplied. Cognitive stimulation: a portable monitor is used to provide visual stimulation, and a directional speaker is used to avoid disturbing the alarm of the patient's life supportimng system. Sleep promotion: the lights are turned off from 10 pm to 7 am, and the indirect light source is used if necessary. |
| Conventional care group | No intervention | –Continuous regional cerebral oxygen saturation and processed electroencephalogram (EEG) are monitored. Conventional care: If sedation is required, dexmedetomidine is considered as the first-line sedative drug. The sedation is interrupted daily and the possibility of awakening is assessed. Pain with NRS score above 3, is controlled with opioid. For patients with Richmond Agitation Sedation Scale (RASS) -4 or -5, possible items are provided. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients over 50 years who are expected to spend more than 24 hours in the intensive care unit
Key exclusion criteria (4 listed)
- Patients who developed delirium before entering the intensive care unit
- Patients with cognitive impairment
- Patients who have hearing or vision deficits, or have difficulty in communication
- Patients who are expected to die within 24 hours or do not want life-sustaining treatment
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 |
|---|---|---|
| Multimodal therapy for prevention of deliriumMultimodal therapy for prevention of delirium | Other | Multimodal therapy group |
Primary outcome
Number of patients with delirium
Time frame: From ICU admission up to day 28 or discharge from ICU or death
Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)
4 secondary outcomes
Delirium-free days
Time frame: From ICU admission up to day 28 or discharge from ICU or death
Severity of delirium
Time frame: From ICU admission up to day 28 or discharge from ICU or death
Accidental extubation or disconnection of treatment devices
Time frame: From ICU admission up to day 28 or discharge from ICU or death
ICU and hospital length of stay
Time frame: From ICU admission up to day 28 or discharge from ICU or death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Intensive Care Unit Delirium
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruitingEarly Phase 1
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Sleep, Circadian Dysregulation
Not yet recruitingEarly Phase 1
Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle
Sleep, Delirium
RecruitingPhase 4
Lemborexant for Sleep and Delirium Prevention in Elderly ICU Patients
Sleep Disturbance, Delirium
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.
Ho Geol Ryu, MD, PhD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal therapy for prevention of delirium in people with Intensive Care Unit Delirium, run by Seoul National University Hospital at 1 site in South Korea.
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: looking for participants now, as of the sponsor's last update on 2 Jun 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leerang Lim, MD (+82-2-2072-2469, erange@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with delirium (time frame: From ICU admission up to day 28 or discharge from ICU or death). 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 2 Jun 2026.