Clinical trial NCT03385993: Digital Rehabilitation Environment Augmenting Medical System
Official title: Digital Rehabilitation Environment Augmenting Medical System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Delirium
Keywords: Delirium Prevention
Virtual Reality
VR
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The purpose of Digital Rehabilitation Environment Augmenting Medical System (D.R.E.A.M.S.) is to research the feasibility and clinical potential of an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness (e.g. pain, anxiety and insomnia) and environmental exposures (noise \& light) that are risk factors for the development of delirium, a common and devastating complication in the intensive care unit (ICU).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria: The study team will exclude patients 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

Primary outcomes:
measure: Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire
timeFrame: Immediately before and after each intervention Up to 7 days
measure: Blood Pressure -Systolic
timeFrame: Immediately before and after each intervention up to 7 days
measure: Heart Rate
timeFrame: Immediately before and after each intervention up to 7 days
Secondary outcomes:
measure: Respiratory Rate
timeFrame: Entire ICU stay up to 7 days
measure: Patient pain perception
timeFrame: Immediately before and after each intervention up to 7 days
measure: Amount of sedatives requested by subjects
timeFrame: Entire ICU stay up to 7 days
measure: Amount of sedatives subjects receive
timeFrame: Entire ICU stay up to 7 days
measure: Subject's quality of sleep
timeFrame: Daily up to 14 days
measure: DREAMS usability and acceptability questionnaire
timeFrame: After each intervention up to 14 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Azra Bihorac, MD
role: PRINCIPAL_INVESTIGATOR
References: