Digital Rehabilitation Environment Augmenting Medical System

NCT03385993 | Active Not Recruiting FDA Device

• 1 other identifier: IRB201703107
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

D.R.E.A.M.S. will assess an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness and environmental exposures that are risk factors for the development of delirium.

Conditions

Delirium

Keywords

Delirium Prevention; Virtual Reality; VR

Outcome Measures

Primary Outcomes (3)

• Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire

  The assessment is used to gauge the subject's level of anxiety and depression 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

  Immediately before and after each intervention Up to 7 days

• Blood Pressure -Systolic

  Alterations to vital signs allow for Non-Verbal Pain assessments

  Immediately before and after each intervention up to 7 days

• Heart Rate

  Alterations to vital signs allow for Non-Verbal Pain assessments

  Immediately before and after each intervention up to 7 days

Secondary Outcomes (6)

• Respiratory Rate

  Entire ICU stay up to 7 days

• Patient pain perception

  Immediately before and after each intervention up to 7 days

• Amount of sedatives requested by subjects

  Entire ICU stay up to 7 days

• Amount of sedatives subjects receive

  Entire ICU stay up to 7 days

• Subject's quality of sleep

  Daily up to 14 days

Study Arms (1)

Mediation and Relaxation Intervention

EXPERIMENTAL

Patients will undergo a technology based guided meditation and relaxation exercise through use of an application on a tablet or virtual reality headset.

Device: Technology based guided meditation and relaxation

Interventions

Technology based guided meditation and relaxation DEVICE

Subjects will be guided through a mediation and relaxation exercise on a tablet or virtual reality headset for up to an hour each day.

Mediation and Relaxation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients ≥ 18 years admitted to University of Florida (UF) Health Shands Hospital who do not have a positive Confusion Assessment Method (CAM) score, including ICU patients.

You may not qualify if:

• Their anticipated ICU stay is less than one day
• Patient is intubated and cannot communicate.
• Age: \< 18 years
• Patient with recent (within 6 months) neuro-vascular event, intra-cranial surgery, and/or acute neurological condition as primary ICU admission reason
• Baseline cognitive impairment (e.g., advanced dementia)
• Patients who are unable to wear or use the DREAMS equipment

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Azra Bihorac, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 29, 2017
• Study Start: January 16, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)