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Intelligent Intensive Care Unit

Motion Analysis of Delirium in Intensive Care Units (ICUs) Subtitle 1: ADAPT: Autonomous Delirium Monitoring and Adaptive Prevention

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02465307
Acronym
ICU_Delirium
Enrollment
130
Registered
2015-06-08
Start date
2016-02-29
Completion date
2028-05-30
Last updated
2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Confusion

Keywords

Consciousness, Alertness, Cognition, Activity level, Delirium, Hyperactive delirium, Hypoactive delirium, Facial expression, Posture, Intensive care unit

Brief 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. 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.

Interventions

Confusion Assessment Method (CAM) score

DEVICEAccelerometer

3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor

DEVICECommercially available camera

As part of facial recognition video system

DEVICEInternet Pod (iPod)

Monitors noise levels in the room

DIAGNOSTIC_TESTCortisol Swab

Cortisol level collected through self administered salivary swab

Sponsors

U.S. National Science Foundation
CollaboratorFED
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
CollaboratorNIH
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

(ICU Patients): * Intensive care unit patient * 18 years of age or older

Exclusion criteria

(ICU Patients): * Anticipated intensive care unit stay less than one day * Less than 18 years of age * Inability to wear a motion sensor watch (ActiGraph) Inclusion Criteria (Healthy Controls): * 18 years of age or older. * sleeps in home environment

Design outcomes

Primary

MeasureTime frameDescription
Freedman Sleep ScaleChanges from Baseline up to 7 DaysTo determine sleep quality of patient for given day.
CAM/CAM-ICUChanges from Baseline up to 7 DaysConfusion 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.Changes from Baseline up to 7 DaysMDAS 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.Changes from Baseline up to 7 DaysScoring 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.

Secondary

MeasureTime frameDescription
Number of subjects who diedBaseline up to 7 DaysDeath at any time during admission
Number of subjects on mechanical ventilationgreater than 48 hoursNumber of subjects requiring mechanical ventilation greater than 48 hours.

Other

MeasureTime frameDescription
Facial amimia versus non-amimia expressions between the groupsChanges from Baseline up to 7 DaysFrequency of presence of facial amimia versus non-amimia expressions between the groups.
Dynamic activity versus static positionChanges from Baseline up to 7 DaysPercentage of time spent moving versus static position

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026