Digital Rehabilitation Environment Augmenting Medical System

NCT ID: NCT03385993

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2028-12-31

Brief Summary

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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

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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).

Conditions

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Delirium

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mediation and Relaxation Intervention

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

Group Type EXPERIMENTAL

Technology based guided meditation and relaxation

Intervention Type 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.

Interventions

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Technology based guided meditation and relaxation

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

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Azra Bihorac, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201703107

Identifier Type: -

Identifier Source: org_study_id

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