Delirium in the Intensive Care UnitNCT07806422
Virtual Reality-based Sensory Stimulation for Delirium Prevention in Intensive Care Units
A study testing immersive VR group in people with Delirium in the Intensive Care Unit, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate whether virtual reality (VR)-based sensory stimulation can help prevent delirium in adult intensive care unit (ICU) patients, compared with an active control condition delivering the same nature-based audiovisual content via a tablet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium in the Intensive Care Unit
- What is being tested?
- immersive VR group
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Admitted to the ICU
- Undergoing or expected to require mechanical ventilation
- Expected ICU stay of at least 48 hours
- Awake or lightly sedated, defined as a Richmond Agitation-Sedation Scale - (RASS) score between -1 and +1
- Able to understand and follow instructions
- Provided informed consent [or surrogate consent, if applicable]
Who cannot join
- Pre-existing cognitive impairment or dementia
- Acute psychiatric illness at admission
- Delirium at enrollment as assessed by CAM-ICU
- Terminal-stage cancer
- APACHE II score > 20
- Severe uncorrectable hearing or visual impairment
- Traumatic brain injury or intracranial drainage tubes that make use of the VR headset impractical
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Southern Medical University Shenzhen Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital
Shenzhen, Guangdong, 518133
Liang Judy, PhD, 37256297, liangsr5@alumni.sysu.edu.cn
About this study
Official title: Virtual Reality-based Sensory Stimulation for Delirium Prevention in Intensive Care Units: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether virtual reality (VR)-based sensory stimulation can help prevent delirium in adult intensive care unit (ICU) patients, compared with an active control condition delivering the same nature-based audiovisual content via a tablet. The main questions it aims to answer are:
- Does VR-based sensory stimulation delay the time to the first delirium event during ICU stay?
- Does VR-based sensory stimulation reduce delirium incidence, duration, and severity?
- What are the effects of the intervention on ICU length of stay, duration of mechanical ventilation, cognitive function at 3 months after ICU discharge, and health-related quality of life? Researchers will compare immersive VR-based sensory stimulation with a non-immersive tablet-based active control to assess the added value of immersion beyond the effects of sensory content alone.
Read more
Participants will:
- Receive either immersive VR-based sensory stimulation or tablet-based sensory stimulation
- Receive one 20-minute session per day for up to 3 days during ICU stay Undergo twice-daily delirium assessments during ICU stay Complete follow-up assessments of cognitive function and health-related quality of life at 3 months after ICU discharge
Read the detailed description
Delirium is a common acute neurocognitive disorder in critically ill patients and is associated with poor short- and long-term outcomes, including prolonged ICU stay, extended mechanical ventilation, persistent cognitive impairment, and reduced quality of life after discharge. Environmental factors in the ICU, particularly sensory deprivation and excessive noise and light disturbance, are recognized as modifiable contributors to delirium risk.
Conventional sensory stimulation has shown potential to delay delirium onset and reduce delirium severity in ICU patients. However, implementation in routine ICU practice is challenging because intervention delivery may be disrupted by the complex ICU environment and may vary across clinical staff and settings.
This study evaluates a virtual reality (VR)-based sensory stimulation intervention designed to provide immersive visual and auditory input while reducing interference from the ICU environment. The intervention uses a head-mounted display and headphones to deliver standardized nature-based content. An active control condition was selected to receive the same content through a tablet, allowing comparison of immersive versus non-immersive delivery while controlling for the sensory content itself.
This study is a pilot randomized controlled trial conducted in adult ICU patients. Participants are randomly assigned in a 1:1 ratio to either the VR intervention group or the active control group. Both groups receive one 20-minute session daily for up to 3 days during ICU stay. Delirium is assessed twice daily during ICU stay, and participants are followed at 3 months after ICU discharge for cognitive and quality-of-life outcomes. The study is intended to generate preliminary estimates of intervention effects and to inform the design of a future definitive trial.
- Conditions
- Delirium in the Intensive Care Unit
- Being tested
- immersive VR group, Active control group
- Keywords
- delirium, ICU, prevention, sensory stimulation, VR
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immersive VR groupDevice
Participants received immersive VR-based sensory stimulation delivered through a head-mounted display with over-ear headphones. The intervention consisted of nature-based audiovisual content delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days.
Active control groupBehavioural
Participants received the same nature-based audiovisual content through a tablet in a non-immersive format for 20 minutes once daily for up to 3 days during ICU stay.
| Study group | Role | What they receive |
|---|---|---|
| immersive VR group | Experimental | Participants received immersive VR-based sensory stimulation delivered through a head-mounted display with over-ear headphones. The intervention consisted of nature-based audiovisual content delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days. Receives: Device: immersive VR group |
| active control group | Active comparator | Participants received the same nature-based audiovisual content delivered through a tablet-based non-immersive format. Sessions were delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days. Receives: Behavioral: Active control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Delirium Event During ICU Stay
Time from study enrollment to the first episode of delirium detected by the Confusion Assessment Method for the ICU (CAM-ICU).
Measured: Every day, from ICU admission to ICU discharge, assessed up to 28 days
Secondary outcomes (6)
Delirium Incidence
Proportion of participants who developed delirium during ICU stay as assessed by CAM-ICU.
Measured: Every day, from ICU admission to ICU discharge, assessed up to 28 days
Delirium Duration
Total number of days during which delirium was present during ICU stay.
Measured: Every day, from ICU admission to ICU discharge, assessed up to 28 days
ICU Length of Stay
Total number of days from ICU admission to ICU discharge.
Measured: From date of ICU admission until the date of ICU discharge, assessed up to 28 days
Duration of Mechanical Ventilation
Total duration of mechanical ventilation during ICU stay.
Measured: From date of randomization until the date of first successful liberation from mechanical ventilation or date of in-hospital death, whichever came first, assessed up to 28 days
Cognitive Function at 3 Months
Cognitive function assessed by the telephone-based Montreal Cognitive Assessment (t-MoCA).
Measured: 3 months after ICU discharge
Health-Related Quality of Life at 3 Months
Health-related quality of life assessed by the EuroQol Five Dimensions Questionnaire (EQ-5D).
Measured: 3 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in the Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Surui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806422
- Sponsor's protocol ID
- NYSZYYEC20230074R003
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-based Sensory Stimulation for Delirium Prevention in Intensive Care Units: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07806422
- Acronym / sponsor ID
- NYSZYYEC20230074R003
- Conditions
- Delirium in the Intensive Care Unit
- Keywords
- delirium, ICU, prevention, sensory stimulation, VR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Sep 2026 (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.
The goal of this clinical trial is to evaluate whether virtual reality (VR)-based sensory stimulation can help prevent delirium in adult intensive care unit (ICU) patients, compared with an active control condition delivering the same nature-based audiovisual content via a tablet. The main questions it aims to answer are:
- Does VR-based sensory stimulation delay the time to the first delirium event during ICU stay?
- Does VR-based sensory stimulation reduce delirium incidence, duration, and severity?
- What are the effects of the intervention on ICU length of stay, duration of mechanical ventilation, cognitive function at 3 months after ICU discharge, and health-related quality of life? Researchers will compare immersive VR-based sensory stimulation with a non-immersive tablet-based active control to assess the added value of immersion beyond the effects of sensory content alone.
Participants will:
- Receive either immersive VR-based sensory stimulation or tablet-based sensory stimulation
- Receive one 20-minute session per day for up to 3 days during ICU stay Undergo twice-daily delirium assessments during ICU stay Complete follow-up assessments of cognitive function and health-related quality of life at 3 months after ICU discharge
Detailed description
Delirium is a common acute neurocognitive disorder in critically ill patients and is associated with poor short- and long-term outcomes, including prolonged ICU stay, extended mechanical ventilation, persistent cognitive impairment, and reduced quality of life after discharge. Environmental factors in the ICU, particularly sensory deprivation and excessive noise and light disturbance, are recognized as modifiable contributors to delirium risk.
Conventional sensory stimulation has shown potential to delay delirium onset and reduce delirium severity in ICU patients. However, implementation in routine ICU practice is challenging because intervention delivery may be disrupted by the complex ICU environment and may vary across clinical staff and settings.
This study evaluates a virtual reality (VR)-based sensory stimulation intervention designed to provide immersive visual and auditory input while reducing interference from the ICU environment. The intervention uses a head-mounted display and headphones to deliver standardized nature-based content. An active control condition was selected to receive the same content through a tablet, allowing comparison of immersive versus non-immersive delivery while controlling for the sensory content itself.
This study is a pilot randomized controlled trial conducted in adult ICU patients. Participants are randomly assigned in a 1:1 ratio to either the VR intervention group or the active control group. Both groups receive one 20-minute session daily for up to 3 days during ICU stay. Delirium is assessed twice daily during ICU stay, and participants are followed at 3 months after ICU discharge for cognitive and quality-of-life outcomes. The study is intended to generate preliminary estimates of intervention effects and to inform the design of a future definitive trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immersive VR group | Experimental | Device: immersive VR groupParticipants received immersive VR-based sensory stimulation delivered through a head-mounted display with over-ear headphones. The intervention consisted of nature-based audiovisual content delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days. |
| active control group | Active comparator | Behavioral: Active control groupParticipants received the same nature-based audiovisual content delivered through a tablet-based non-immersive format. Sessions were delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Admitted to the ICU
- Undergoing or expected to require mechanical ventilation
- Expected ICU stay of at least 48 hours
- Awake or lightly sedated, defined as a Richmond Agitation-Sedation Scale - (RASS) score between -1 and +1
Key exclusion criteria (7 listed)
- Pre-existing cognitive impairment or dementia
- Acute psychiatric illness at admission
- Delirium at enrollment as assessed by CAM-ICU
- Terminal-stage cancer
- APACHE II score > 20
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 |
|---|---|---|
| immersive VR groupParticipants received immersive VR-based sensory stimulation delivered through a head-mounted display with over-ear headphones. The intervention consisted of nature-based audiovisual content delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days. | Device | immersive VR group |
| Active control groupParticipants received the same nature-based audiovisual content through a tablet in a non-immersive format for 20 minutes once daily for up to 3 days during ICU stay. | Behavioural | active control group |
Primary outcome
Time to First Delirium Event During ICU Stay
Time frame: Every day, from ICU admission to ICU discharge, assessed up to 28 days
Time from study enrollment to the first episode of delirium detected by the Confusion Assessment Method for the ICU (CAM-ICU).
6 secondary outcomes
Delirium Incidence
Time frame: Every day, from ICU admission to ICU discharge, assessed up to 28 days
Delirium Duration
Time frame: Every day, from ICU admission to ICU discharge, assessed up to 28 days
ICU Length of Stay
Time frame: From date of ICU admission until the date of ICU discharge, assessed up to 28 days
Duration of Mechanical Ventilation
Time frame: From date of randomization until the date of first successful liberation from mechanical ventilation or date of in-hospital death, whichever came first, assessed up to 28 days
Cognitive Function at 3 Months
Time frame: 3 months after ICU discharge
Health-Related Quality of Life at 3 Months
Time frame: 3 months after ICU discharge
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 8 Sep 2026.
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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.
Southern Medical University Shenzhen Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital
Shenzhen, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immersive VR group in people with Delirium in the Intensive Care Unit, run by Chinese University of Hong Kong at 1 site in China.
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 7 inclusion and 7 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 8 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Delirium Event During ICU Stay (time frame: Every day, from ICU admission to ICU discharge, assessed up to 28 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 8 Sep 2026.