Critical CareNCT05518955
VR Integrated Into Multicomponent Interventions for Improving Sleep in ICU
A study testing Virtual reality and eye mask in people with Critical Care and Sleep Quality, run by Hsiao-Yean Chiu at 1 site in Taiwan.
Trial summary
Background: The patients who are admitted to ICUs mostly experience sleep disturbance. Seeking an effective strategy and integrating it into the daily routine is of clinical importance. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Critical Care, Sleep Quality
- What is being tested?
- Virtual reality and eye mask
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2022to 3 Feb 2025
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20 years and above.
- Conscious and able to communicate with Chinese or Mandarin.
- To stay in ICU at least 72 hrs
Who cannot join
- The medical history of sleep disorder, cognition impairment, psychiatric disorders, seizures, visual difficulty or hearing difficulty
- The APACHE II score over than 25
- The participates who are delirium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strategies Establishment for Promoting Sleep Quality and Quantity of Patients Requiring Intensive Care: Verifying the Effect of Virtual Reality Integrated Into Multicomponent Interventions
Background: The patients who are admitted to ICUs mostly experience sleep disturbance. Seeking an effective strategy and integrating it into the daily routine is of clinical importance. Therefore, we aim to examine the effects of guided virtual reality integrated into the multicomponent program (SLEEP care) on sleep quality and quantity in critically ill patients. This will be a randomized controlled trial with assessor-blinded and two-arm parallel-group design. A total of 120 critical ill adults will be randomly allocated to the SLEEP care group and eyemask groups in a 1:1 ratio (60 participants in each group).
Read the detailed description
This study is expected to enroll 120 critically ill patients. We will collect basic data on the first day of admission to the intensive care unit, including demographics and disease characteristics, pain, anxiety, and stress, sleep quality and quantity, measure 5-minute HRV, wear an actigraph watch, and connect to the on-lead EEG sensor, and attach the brain wave to monitor the brain wave and sleep cycle. Then they will be randomly assigned 1:1, dividing into SLEEP care group and eyemask group. Participants who are in the control will receive eyemask intervention and daily care in the ICU. Participants who are assigned to the SLEEP care group will receive the VR and night sleep promotion routine. The researcher will assist participants to wear a virtual reality helmet for a 30-minute program at 10 pm, and then remove the helmet and wear eye masks until 6:30 in the morning. The ICU routine care of promoting sleep is still maintained. The next morning (the second day of the ICU), the researcher will assist participants to remove EEG sensors and evaluate the RCSQ scale to understand the previous night's sleep. The above process will repeat for three days (ICU days 1 to 3) until the intervention and measurement during the intensive care unit are completed on the morning of the fourth day. In order to understand the impact of sleep on cognitive function during the stay in the intensive care units and after discharge, the PSQI, VAS of pain, anxiety, and stress (confounders), and MOCA will be evaluated in the first and sixth months after discharge.
- Conditions
- Critical Care, Sleep Quality
- Being tested
- Virtual reality and eye mask
- Keywords
- Intensive care unit, Sleep deprivation, Virtual reality, multicomponent intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality and eye maskBehavioural
Participates will receive a virtual reality program 30 min before their sleep and combine with the sleep routine program for consecutive 2 nights in the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality combine with sleep promotion routine | Experimental | Participants will receive virtual reality for 30 minutes before bedtime then will be placed on an eye mask and combine with the sleep promotion routine. The intervention duration need continues for two days or until discharge from ICU. Receives: Behavioral: Virtual reality and eye mask |
| control group | No intervention | Participants will receive eye masks during their sleep for consecutive two days or until discharge from ICU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subjective sleep quality from first day to 3rd day of ICU recruitment
Subjective sleep quality in ICU is assessed by Richards-Campbell Sleep Questionnaire(RCSQ). The mean of total score is 0-100. The higher score means the better sleep quality.
Measured: The 1st to 3rd day of ICU recruitment
Change of subjective sleep quality from before ICU and admission for 30 and 180 days after ICU discharge
sleep quality is assessed by Pittsburgh Sleep Quality. Index(PSQI). The total score is 0-21. The higher score means the worse sleep quality.
Measured: The 1st day of ICU recruitment, 30 and 180 days days after ICU discharge
Change of objective sleep from 1st day to 3rd day of ICU recruitment
Objective sleep quality in ICU is measured by actigraphy
Measured: The 1st day to 3rd day of ICU recruitment
Secondary outcomes (7)
Change of quality of life from the first day of ICU recruitment, 30 and 180 day after ICU discharge
Cognitive function is assessed by MoCA. The total scales is 30. The scale is more than 26 means the patients do not have cognitive impairment.
Measured: The 30 and 180 days after ICU discharge
Delirium occurrence
Delirium is assessed by Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the intensive care unit (CAM-ICU)
Measured: The 1st to 3th days of ICU recruitment
Change of heart rate variability
Heart rate variability is measured by portable ECG recorder and analyzer.
Measured: The 1st and 3rd days of ICU recruitment
Change from baseline on anxiety
Anxiety is assessed by Visual Analog Scale (VAS) anxiety scoring.The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain(score of 10) .The higher score means the very anxiety.
Measured: the 1st day of ICU recruitment and up to 30 and 180 days
Change of stress
Stress is assessed by Visual Analog Scale(VAS) stress scoring.The scale is most commonly anchored by "no stress" (score of 0) and "very stressful(score of 10) .The higher score means the very stressful.
Measured: The 1st day of ICU recruitment, 30 and 180 days after ICU discharge
Change of pain
Pain is assessed by Visual Analog Scale(VAS) pain scoring.The scale is most commonly anchored by "no pain" (score of 0) and "very painful(score of 10) .The higher score means the very painful.
Measured: The 1st day of ICU recruitment, 30 and 180 days days after ICU discharge
Electroencephalography
Electroencephalography is measured by SOMNOwatch
Measured: The 1st day to 3rd day of ICU recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start20 Sep 2022
- Primary completion6 Mar 2024
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hsiao-Yean Chiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hsiao-Yean Chiu, Taipei Medical University
- Investigators
- Hsiao-Yean Chiu, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518955
- Sponsor's protocol ID
- N202202058
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2022
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies Establishment for Promoting Sleep Quality and Quantity of Patients Requiring Intensive Care: Verifying the Effect of Virtual Reality Integrated Into Multicomponent Interventions
- ClinicalTrials.gov ID
- NCT05518955
- Acronym / sponsor ID
- N202202058
- Conditions
- Critical Care, Sleep Quality
- Keywords
- Intensive care unit, Sleep deprivation, Virtual reality, multicomponent intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hsiao-Yean ChiuUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 29 Aug 2022 (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.
Background: The patients who are admitted to ICUs mostly experience sleep disturbance. Seeking an effective strategy and integrating it into the daily routine is of clinical importance. Therefore, we aim to examine the effects of guided virtual reality integrated into the multicomponent program (SLEEP care) on sleep quality and quantity in critically ill patients. This will be a randomized controlled trial with assessor-blinded and two-arm parallel-group design. A total of 120 critical ill adults will be randomly allocated to the SLEEP care group and eyemask groups in a 1:1 ratio (60 participants in each group).
Detailed description
This study is expected to enroll 120 critically ill patients. We will collect basic data on the first day of admission to the intensive care unit, including demographics and disease characteristics, pain, anxiety, and stress, sleep quality and quantity, measure 5-minute HRV, wear an actigraph watch, and connect to the on-lead EEG sensor, and attach the brain wave to monitor the brain wave and sleep cycle. Then they will be randomly assigned 1:1, dividing into SLEEP care group and eyemask group. Participants who are in the control will receive eyemask intervention and daily care in the ICU. Participants who are assigned to the SLEEP care group will receive the VR and night sleep promotion routine. The researcher will assist participants to wear a virtual reality helmet for a 30-minute program at 10 pm, and then remove the helmet and wear eye masks until 6:30 in the morning. The ICU routine care of promoting sleep is still maintained. The next morning (the second day of the ICU), the researcher will assist participants to remove EEG sensors and evaluate the RCSQ scale to understand the previous night's sleep. The above process will repeat for three days (ICU days 1 to 3) until the intervention and measurement during the intensive care unit are completed on the morning of the fourth day. In order to understand the impact of sleep on cognitive function during the stay in the intensive care units and after discharge, the PSQI, VAS of pain, anxiety, and stress (confounders), and MOCA will be evaluated in the first and sixth months after discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality combine with sleep promotion routine | Experimental | Behavioral: Virtual reality and eye maskParticipants will receive virtual reality for 30 minutes before bedtime then will be placed on an eye mask and combine with the sleep promotion routine. The intervention duration need continues for two days or until discharge from ICU. |
| control group | No intervention | –Participants will receive eye masks during their sleep for consecutive two days or until discharge from ICU. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 20 years and above.
- Conscious and able to communicate with Chinese or Mandarin.
- To stay in ICU at least 72 hrs
Key exclusion criteria (3 listed)
- The medical history of sleep disorder, cognition impairment, psychiatric disorders, seizures, visual difficulty or hearing difficulty
- The APACHE II score over than 25
- The participates who are delirium
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 |
|---|---|---|
| Virtual reality and eye maskParticipates will receive a virtual reality program 30 min before their sleep and combine with the sleep routine program for consecutive 2 nights in the ICU. | Behavioural | Virtual reality combine with sleep promotion routine |
Primary outcome
Changes in subjective sleep quality from first day to 3rd day of ICU recruitment
Time frame: The 1st to 3rd day of ICU recruitment
Subjective sleep quality in ICU is assessed by Richards-Campbell Sleep Questionnaire(RCSQ). The mean of total score is 0-100. The higher score means the better sleep quality.
Change of subjective sleep quality from before ICU and admission for 30 and 180 days after ICU discharge
Time frame: The 1st day of ICU recruitment, 30 and 180 days days after ICU discharge
sleep quality is assessed by Pittsburgh Sleep Quality. Index(PSQI). The total score is 0-21. The higher score means the worse sleep quality.
Change of objective sleep from 1st day to 3rd day of ICU recruitment
Time frame: The 1st day to 3rd day of ICU recruitment
Objective sleep quality in ICU is measured by actigraphy
7 secondary outcomes
Change of quality of life from the first day of ICU recruitment, 30 and 180 day after ICU discharge
Time frame: The 30 and 180 days after ICU discharge
Delirium occurrence
Time frame: The 1st to 3th days of ICU recruitment
Change of heart rate variability
Time frame: The 1st and 3rd days of ICU recruitment
Change from baseline on anxiety
Time frame: the 1st day of ICU recruitment and up to 30 and 180 days
Change of stress
Time frame: The 1st day of ICU recruitment, 30 and 180 days after ICU discharge
Change of pain
Time frame: The 1st day of ICU recruitment, 30 and 180 days days after ICU discharge
Electroencephalography
Time frame: The 1st day to 3rd day of ICU recruitment
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 17 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Hsiao-Yean Chiu principal investigator
Taipei Medical 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 Virtual reality and eye mask in people with Critical Care and Sleep Quality, run by Hsiao-Yean Chiu at 1 site in Taiwan.
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 3 inclusion and 3 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 17 Aug 2025. 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 Taiwan. 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?
Changes in subjective sleep quality from first day to 3rd day of ICU recruitment (time frame: The 1st to 3rd day of ICU recruitment). The study lists 3 primary outcomes in all. 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 17 Aug 2025.