DeliriumICU_DeliriumNCT02465307
Intelligent Intensive Care Unit
An observational study of Delirium and Confusion, run by University of Florida at 1 site in United States.
Trial summary
Delirium, as a common complication of hospitalization, poses significant health problems in hospitalized patients. Though about a third of delirium cases can benefit from intervention, detecting and predicting delirium is still very limited in practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Confusion Assessment Method, Accelerometer and Commercially available camera
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 30 May 2028
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: ICU Patients: Patients who been hospitalized in an intensive care unit and have risk factors to develop delirium or delirium has been suspected by their medical provider. Healthy Controls: People who are healthy and sleep in their home environment.
Who may be able to join
- Intensive care unit patient
- 18 years of age or older
- 18 years of age or older.
- sleeps in home environment
Who cannot join
- Anticipated intensive care unit stay less than one day
- Less than 18 years of age
- Inability to wear a motion sensor watch (ActiGraph)
- does not sleep in home environment
- Less than 18 years of age
- Inability to wear a motion sensor watch (ActiGraph)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motion Analysis of Delirium in Intensive Care Units (ICUs) Subtitle 1: "ADAPT: Autonomous Delirium Monitoring and Adaptive Prevention"
Delirium, as a common complication of hospitalization, poses significant health problems in hospitalized patients. Though about a third of delirium cases can benefit from intervention, detecting and predicting delirium is still very limited in practice. A common characterization of delirium is change in activity level, causing patients to become hyperactive or hypoactive which is manifested in facial expressions and total body movements. This pilot study is designed to test the feasibility of a delirium detection system using movement data obtained from 3-axis wearable accelerometers and commercially available camera with facial recognition video system in conjunction with electronics medical record (EMR) data to analyze the relation of whole-body movement and facial expressions with delirium.
Read the detailed description
The aim of the study is to assess the potential of using motion and facial expression data to detect delirium in ICU patients by comparing motion and facial expression patterns in delirium and control groups. In this study, the investigators will use ActiGraph accelerometers to record each subject's movement patterns. Also, a processed video using a commercially available camera interfaces with a specialized program to identify patient facial expressions and movement patterns. A total of 60 participants will be enrolled with delirium, and 30 patients without delirium will be used as control group. Motion profiles will be compared in the motorically defined subgroups (hyperactive, hypoactive, normal) based on accelerometer and facial recognition data. Then, differences in facial expression, number of changes in postures, and percentage of time spent moving will be compared between motorically defined subgroups and in delirium and control groups. EMR data will also be used to assess the feasibility of detecting delirium by including additional information on related risk factors.
- Being tested
- Confusion Assessment Method, Accelerometer, Commercially available camera, Internet Pod (iPod), Cortisol Swab
- Keywords
- Consciousness, Alertness, Cognition, Activity level, Delirium, Hyperactive delirium, Hypoactive delirium, Facial expression, Posture, Intensive care unit
- Medical subject headings
- Delirium, Confusion, Facial Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confusion Assessment MethodBehavioural
Confusion Assessment Method (CAM) score
AccelerometerDevice
3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor
Commercially available cameraDevice
Also called imaging
As part of facial recognition video system
Internet Pod (iPod)Device
Also called Sound detection
Monitors noise levels in the room
Cortisol SwabDiagnostic test
Cortisol level collected through self administered salivary swab
| Study group | Role | What they receive |
|---|---|---|
| Delirium group | ICU patients with a positive Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod). Receives: Behavioral: Confusion Assessment Method; Device: Accelerometer; Device: Commercially available camera; Device: Internet Pod (iPod) | |
| Control group | ICU patients with a negative Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod). Receives: Behavioral: Confusion Assessment Method; Device: Accelerometer; Device: Commercially available camera; Device: Internet Pod (iPod) | |
| Healthy control group | Healthy subjects that sleep in their home environment; observational using accelerometers, cortisol swabs, and Internet Pod (iPod) Receives: Device: Accelerometer; Device: Internet Pod (iPod); Diagnostic Test: Cortisol Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAM/CAM-ICU
Confusion Assessment Method for detection of delirium
Measured: Changes from Baseline up to 7 Days
Memorial Delirium Assessment Scale (MDAS) will be used for changes from baseline up to 7 days between the groups.
MDAS denotes motor profile and defines motor subtyping. It has 10 items which assesses several areas of cognitive functioning (memory, attention, orientation and disturbances in thinking) and psychomotor activity. The items are rated on a four point scale (0-3) based on the current interaction with the patient or by assessment of behavior. A score of 13 shows the diagnosis of delirium.
Measured: Changes from Baseline up to 7 Days
Delirium Motor Subtyping Scale (DMSS-4) will be used for changes from baseline up to 7 days between the groups.
Scoring from DMSS-4 which has 5 hyperactive and 8 hypoactive symptoms requires at least two symptoms to be present from either the hyperactive or hypoactive list to meet subtype criteria. The higher the score the higher the delirium.
Measured: Changes from Baseline up to 7 Days
Freedman Sleep Scale
To determine sleep quality of patient for given day.
Measured: Changes from Baseline up to 7 Days
Secondary outcomes (2)
Number of subjects who died
Death at any time during admission
Measured: Baseline up to 7 Days
Number of subjects on mechanical ventilation
Number of subjects requiring mechanical ventilation greater than 48 hours.
Measured: greater than 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startFeb 2016
- Primary completion11 Mar 2020
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation, National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Azra Bihorac, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465307
- Sponsor's protocol ID
- IRB201400546 -N
- Other IDs
- 1750192, 1R21EB027344-01, R01NS120924-01
- Acronym
- ICU_Delirium
- Status last verified
- Jul 2026
- First submitted
- 29 May 2015
- Last updated
- 21 Jul 2026
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Analysis of Delirium in Intensive Care Units (ICUs) Subtitle 1: "ADAPT: Autonomous Delirium Monitoring and Adaptive Prevention"
- ClinicalTrials.gov ID
- NCT02465307
- Acronym / sponsor ID
- ICU_Delirium / IRB201400546 -N
- Keywords
- Consciousness, Alertness, Cognition, Activity level, Delirium, Hyperactive delirium, Hypoactive delirium, Facial expression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation, National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Feb 2016 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 8 Jun 2015 (estimated)
- 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.
Delirium, as a common complication of hospitalization, poses significant health problems in hospitalized patients. Though about a third of delirium cases can benefit from intervention, detecting and predicting delirium is still very limited in practice. A common characterization of delirium is change in activity level, causing patients to become hyperactive or hypoactive which is manifested in facial expressions and total body movements. This pilot study is designed to test the feasibility of a delirium detection system using movement data obtained from 3-axis wearable accelerometers and commercially available camera with facial recognition video system in conjunction with electronics medical record (EMR) data to analyze the relation of whole-body movement and facial expressions with delirium.
Detailed description
The aim of the study is to assess the potential of using motion and facial expression data to detect delirium in ICU patients by comparing motion and facial expression patterns in delirium and control groups. In this study, the investigators will use ActiGraph accelerometers to record each subject's movement patterns. Also, a processed video using a commercially available camera interfaces with a specialized program to identify patient facial expressions and movement patterns. A total of 60 participants will be enrolled with delirium, and 30 patients without delirium will be used as control group. Motion profiles will be compared in the motorically defined subgroups (hyperactive, hypoactive, normal) based on accelerometer and facial recognition data. Then, differences in facial expression, number of changes in postures, and percentage of time spent moving will be compared between motorically defined subgroups and in delirium and control groups. EMR data will also be used to assess the feasibility of detecting delirium by including additional information on related risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delirium group | – | Behavioral: Confusion Assessment Method, Device: Accelerometer, Device: Commercially available camera, Device: Internet Pod (iPod)ICU patients with a positive Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod). |
| Control group | – | Behavioral: Confusion Assessment Method, Device: Accelerometer, Device: Commercially available camera, Device: Internet Pod (iPod)ICU patients with a negative Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod). |
| Healthy control group | – | Device: Accelerometer, Device: Internet Pod (iPod), Diagnostic Test: Cortisol SwabHealthy subjects that sleep in their home environment; observational using accelerometers, cortisol swabs, and Internet Pod (iPod) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ICU Patients: Patients who been hospitalized in an intensive care unit and have risk factors to develop delirium or delirium has been suspected by their medical provider. Healthy Controls: People who are healthy and sleep in their home environment.
Key inclusion criteria (4 listed)
- Intensive care unit patient
- 18 years of age or older
- 18 years of age or older.
- sleeps in home environment
Key exclusion criteria (6 listed)
- Anticipated intensive care unit stay less than one day
- Less than 18 years of age
- Inability to wear a motion sensor watch (ActiGraph)
- does not sleep in home environment
- Less than 18 years of age
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 |
|---|---|---|
| Confusion Assessment MethodConfusion Assessment Method (CAM) score | Behavioural | Control group, Delirium group |
| Accelerometer3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor | Device | Control group, Delirium group, Healthy control group |
| Commercially available cameraAlso: imagingAs part of facial recognition video system | Device | Control group, Delirium group |
| Internet Pod (iPod)Also: Sound detectionMonitors noise levels in the room | Device | Control group, Delirium group, Healthy control group |
| Cortisol SwabCortisol level collected through self administered salivary swab | Diagnostic test | Healthy control group |
Primary outcome
CAM/CAM-ICU
Time frame: Changes from Baseline up to 7 Days
Confusion Assessment Method for detection of delirium
Memorial Delirium Assessment Scale (MDAS) will be used for changes from baseline up to 7 days between the groups.
Time frame: Changes from Baseline up to 7 Days
MDAS denotes motor profile and defines motor subtyping. It has 10 items which assesses several areas of cognitive functioning (memory, attention, orientation and disturbances in thinking) and psychomotor activity. The items are rated on a four point scale (0-3) based on the current interaction with the patient or by assessment of behavior. A score of 13 shows the diagnosis of delirium.
Delirium Motor Subtyping Scale (DMSS-4) will be used for changes from baseline up to 7 days between the groups.
Time frame: Changes from Baseline up to 7 Days
Scoring from DMSS-4 which has 5 hyperactive and 8 hypoactive symptoms requires at least two symptoms to be present from either the hyperactive or hypoactive list to meet subtype criteria. The higher the score the higher the delirium.
Freedman Sleep Scale
Time frame: Changes from Baseline up to 7 Days
To determine sleep quality of patient for given day.
2 secondary outcomes
Number of subjects who died
Time frame: Baseline up to 7 Days
Number of subjects on mechanical ventilation
Time frame: greater than 48 hours
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 21 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Delirium
Not yet recruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Active, not recruitingObservational study
Delirium in Children Undergoing Stem Cell Transplantation
Stem Cell Transplant Complications, Delirium
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative 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. This study is not recruiting at the moment.
Azra Bihorac, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Confusion, run by University of Florida at 1 site in United States.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 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 United States. 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?
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?
CAM/CAM-ICU (time frame: Changes from Baseline up to 7 Days). The study lists 4 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 21 Jul 2026.