Delirium, PostoperativeDREAMS-OTNCT06107517
Reducing Delirium After CABG Surgery With Early Activation and Sleep-Promoting Routines
A study testing DREAMS-OT in people with Delirium, Postoperative, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The goal of this randomized-controlled trial (RCT) is to compare the effectiveness of the DREAMS-OT intervention with standard care in reducing post-Coronary Artery Bypass Graft (CABG) surgery delirium in patients undergoing CABG surgery. The aims of the study are: 1. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Delirium, Postoperative
- What is being tested?
- DREAMS-OT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Jan 2024to Aug 2026
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients deemed medically suitable for elective CABG surgery
- Patients aged 21 years and above
- Patients who are English or Mandarin speaking.
- Patients who are able to provide consent
Who cannot join
- Patients who speak other languages are excluded due to the language requirements of certain outcome measures.
- Patients with premorbid severe hearing impairment, severe cognitive impairment, progressive neurological disorders and psychological disorders will be excluded.
- Patients with surgical complications resulting in profuse bleeding from any invasive sites, septic shock unresponsive to maximal treatment, and those who are moribund or have an expected mortality within 48 hours will be excluded.
- Pregnant women will also be excluded from the study as well.
- Patients who develop delirium before initiation of the treatment are also excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Su Ren Wong, +65-90279451, su_ren_wong@nuhs.edu.sg
Megan HL Tan, megan_huei_lin_tan@nuhs.edu.sg
About this study
Official title: DREAMS-OT Trial: Delirium Reduction Through Early Activation in Motivating and Sleep Promoting Routines: A Randomized Controlled Trial of Occupational Therapy for ICU Patients After Coronary Artery Bypass Graft (CABG) Surgery
The goal of this randomized-controlled trial (RCT) is to compare the effectiveness of the DREAMS-OT intervention with standard care in reducing post-Coronary Artery Bypass Graft (CABG) surgery delirium in patients undergoing CABG surgery.
The aims of the study are:
- To determine if early and intensive OT will lower the incidence of post-op delirium in CABG patients compared to standard are.
- To determine the cost effectiveness of the DREAMS-OT intervention.
The study team will compare intervention group and standard care group (control group) to see if there is a reduction in the incidence of delirium in patients 5 days post-CABG.
- Conditions
- Delirium, Postoperative
- Being tested
- DREAMS-OT
- Keywords
- Delirium, Coronary Artery Bypass Grafting, Occupational Therapy, Intensive Care Units, Randomized Controlled Trial
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DREAMS-OTOther
Patients will receive the DREAMS-OT protocol 3 times per day, 20 minutes per therapy session.
Intervention frequency will be confirmed with a feasibility trial. If not feasible to maintain 3 times per day, the intervention will still be maintained at the same intensity of 1 hour per day, with a graded approach.
| Study group | Role | What they receive |
|---|---|---|
| DREAMS-OT Arm (Intervention Group) | Experimental | Patients will receive an early and intensive occupational therapy protocol starting within the first 15 hours after extubation. Receives: Other: DREAMS-OT |
| Standard Care Arm (Control Group) | No intervention | Standard care OT as per current ICU setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Incidence of delirium from Day 1 to Day 5 post-CABG are measured using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment tool.
Measured: Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM); (+/- 1 day for last measurement)
Delirium
Incidence of delirium from Day 1 to Day 5 post-CABG are measured using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).
Measured: Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM); (+/- 1 day for last measurement)
Secondary outcomes (8)
Length of Stay
Length of stay in ICU and hospital in days
Measured: 3-months post-CABG (+/- 1 month)
Duration of Delirium
Duration of delirium in subgroup of participants who develop delirium
Measured: Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM)
Sleep Quality
Sleep quality (Duration of Total Sleep, Light Sleep, Deep Sleep and Rapid Eye Movement (REM) Sleep in hours) as measured with Oura Ring, a wearable sleep tracking device
Measured: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 1 of post-CABG, Day 2 of post-CABG (+/- 1 day), 3 months post-CABG for 3 consecutive days (+/- 1 month)
Functional Status
Functional status measured using Acute Care Index of Function (ACIF). The score ranges from 0 - 176 (or 206 for wheelchair-bound participants), with higher scores indicating better functional performance.
Measured: Day 5 of post-CABG (+/- 1 day)
Physical Status
Physical status measured using Functional Independence Measure (FIM). The score ranges from 0 - 126, with higher scores indicating better physical status.
Measured: Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)
Cognitive status
Cognitive status measurement using Montreal Cognitive Assessment (MoCA). The score ranges from 0 - 30, with higher scores indicating better cognitive status.
Measured: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)
Psychological State
Psychological state measured using the Hospital Anxiety and Depression Scale (HADS). The score ranges from 0 - 21, with higher scores indicating worse psychological state.
Measured: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/-1 day), 3 months post-CABG (+/- 1 month)
Cognitive status
Cognitive status measured using the Weekly Calendar Planning Activity (WCPA) is assessed using an efficiency score derived from accuracy and time to completion. Higher scores indicate better performance. The score is a continuous variable without a fixed range.
Measured: 3-months post-CABG (+/- 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start8 Jan 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, PostoperativeStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore, National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Su Ren Wong, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107517
- Sponsor's protocol ID
- 2022/00936
- Acronym
- DREAMS-OT
- Status last verified
- Dec 2025
- First submitted
- 24 Oct 2023
- Last updated
- 30 Mar 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DREAMS-OT Trial: Delirium Reduction Through Early Activation in Motivating and Sleep Promoting Routines: A Randomized Controlled Trial of Occupational Therapy for ICU Patients After Coronary Artery Bypass Graft (CABG) Surgery
- ClinicalTrials.gov ID
- NCT06107517
- Acronym / sponsor ID
- DREAMS-OT / 2022/00936
- Conditions
- Delirium, Postoperative
- Keywords
- Delirium, Coronary Artery Bypass Grafting, Occupational Therapy, Intensive Care Units, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore, National Medical Research Council (NMRC), Singapore
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 30 Oct 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.
The goal of this randomized-controlled trial (RCT) is to compare the effectiveness of the DREAMS-OT intervention with standard care in reducing post-Coronary Artery Bypass Graft (CABG) surgery delirium in patients undergoing CABG surgery.
The aims of the study are:
- To determine if early and intensive OT will lower the incidence of post-op delirium in CABG patients compared to standard are.
- To determine the cost effectiveness of the DREAMS-OT intervention.
The study team will compare intervention group and standard care group (control group) to see if there is a reduction in the incidence of delirium in patients 5 days post-CABG.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DREAMS-OT Arm (Intervention Group) | Experimental | Other: DREAMS-OTPatients will receive an early and intensive occupational therapy protocol starting within the first 15 hours after extubation. |
| Standard Care Arm (Control Group) | No intervention | –Standard care OT as per current ICU setting |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients deemed medically suitable for elective CABG surgery
- Patients aged 21 years and above
- Patients who are English or Mandarin speaking.
- Patients who are able to provide consent
Key exclusion criteria (5 listed)
- Patients who speak other languages are excluded due to the language requirements of certain outcome measures.
- Patients with premorbid severe hearing impairment, severe cognitive impairment, progressive neurological disorders and psychological disorders will be excluded.
- Patients with surgical complications resulting in profuse bleeding from any invasive sites, septic shock unresponsive to maximal treatment, and those who are moribund or have an expected mortality within 48 hours will be excluded.
- Pregnant women will also be excluded from the study as well.
- Patients who develop delirium before initiation of the treatment are also excluded from the study.
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 |
|---|---|---|
| DREAMS-OTPatients will receive the DREAMS-OT protocol 3 times per day, 20 minutes per therapy session. Intervention frequency will be confirmed with a feasibility trial. If not feasible to maintain 3 times per day, the intervention will still be maintained at the same intensity of 1 hour per day, with a graded approach. | Other | DREAMS-OT Arm (Intervention Group) |
Primary outcome
Delirium
Time frame: Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM); (+/- 1 day for last measurement)
Incidence of delirium from Day 1 to Day 5 post-CABG are measured using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment tool.
Delirium
Time frame: Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM); (+/- 1 day for last measurement)
Incidence of delirium from Day 1 to Day 5 post-CABG are measured using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).
8 secondary outcomes
Length of Stay
Time frame: 3-months post-CABG (+/- 1 month)
Duration of Delirium
Time frame: Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM)
Sleep Quality
Time frame: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 1 of post-CABG, Day 2 of post-CABG (+/- 1 day), 3 months post-CABG for 3 consecutive days (+/- 1 month)
Functional Status
Time frame: Day 5 of post-CABG (+/- 1 day)
Physical Status
Time frame: Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)
Cognitive status
Time frame: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)
Psychological State
Time frame: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/-1 day), 3 months post-CABG (+/- 1 month)
Cognitive status
Time frame: 3-months post-CABG (+/- 1 month)
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 30 Mar 2026.
- 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.
Su Ren Wong principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DREAMS-OT in people with Delirium, Postoperative, run by National University Hospital, Singapore at 1 site in Singapore.
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 4 inclusion and 5 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 30 Mar 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 Singapore. 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 Megan HL Tan (+65-96280613, megan_huei_lin_tan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM); (+/- 1 day for last measurement)). The study lists 2 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 30 Mar 2026.