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Active, Not Recruiting

NCT Number: NCT02465307

Intelligent Intensive Care Unit

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Delirium Behavior Communication Confusion Facial Expression Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nonverbal Communication Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

(Healthy Controls):

  • does not sleep in home environment
  • Less than 18 years of age
  • Inability to wear a motion sensor watch (ActiGraph)

Treatment and study plan

Confusion Assessment Method

Behavioral

Confusion Assessment Method (CAM) score

Accelerometer

Device

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

Commercially available camera

Device

As part of facial recognition video system

Other names: imaging

Internet Pod (iPod)

Device

Monitors noise levels in the room

Other names: Sound detection

Cortisol Swab

Diagnostic Test

Cortisol level collected through self administered salivary swab

Primary outcomes

  1. CAM/CAM-ICU

    Time frame: Changes from Baseline up to 7 Days

    Confusion Assessment Method for detection of delirium

  2. 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.

  3. 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.

  4. Freedman Sleep Scale

    Time frame: Changes from Baseline up to 7 Days

    To determine sleep quality of patient for given day.

Secondary outcomes

  1. Number of subjects who died

    Time frame: Baseline up to 7 Days

    Death at any time during admission

  2. Number of subjects on mechanical ventilation

    Time frame: greater than 48 hours

    Number of subjects requiring mechanical ventilation greater than 48 hours.

Other outcomes

  1. Facial amimia versus non-amimia expressions between the groups

    Time frame: Changes from Baseline up to 7 Days

    Frequency of presence of facial amimia versus non-amimia expressions between the groups.

  2. Dynamic activity versus static position

    Time frame: Changes from Baseline up to 7 Days

    Percentage of time spent moving versus static position

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • U.S. National Science Foundation

Registry information

Official study title

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

Acronym: ICU_Delirium

Important dates

Study start
2016
Primary completion
2020
Study completion
2028
First posted
Jun 8, 2015
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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