What is the mechanism of action of this treatment?

Common treatments for delirium include pharmacological interventions like antipsychotics, which work by modulating neurotransmitter activity to reduce symptoms such as agitation and hallucinations. Non-pharmacological approaches, such as environmental modifications and cognitive therapies, aim to reduce stressors and improve orientation and cognitive function. The Immersive Digital Reality-Augmenting System (D.R.E.A.M.S.) aligns with these non-pharmacological strategies by providing a controlled, engaging environment that can mitigate stressors and enhance cognitive and emotional outcomes. This is crucial for delirium patients as it helps stabilize their mental state, reduces confusion, and promotes recovery without the side effects associated with medications.

What side effects are associated with this type of intervention?

Common treatments for delirium include pharmacological interventions like antipsychotics and sedatives, which can cause side effects such as sedation, extrapyramidal symptoms, and cardiovascular issues. Non-pharmacological treatments, such as cognitive therapies and environmental modifications, generally have fewer side effects but may include temporary discomfort or anxiety as patients adjust to new routines or environments.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for delirium mentioned in the provided context. However, the Immersive Digital Reality-Augmenting System being studied aims to reduce cognitive, behavioral, and emotional consequences of critical illness and environmental exposures, which are risk factors for delirium. This approach is innovative and focuses on creating a controlled, engaging environment to mitigate stressors and improve cognitive and emotional outcomes. Traditional treatments for delirium often include addressing underlying causes, providing supportive care, and sometimes using medications like antipsychotics to manage severe symptoms.

What other types of research exist?

Promising, novel alternatives to the Immersive Digital Reality-Augmenting System for delirium patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown benefits in improving cognitive and emotional outcomes in various neurological conditions. 2) Repetitive Transcranial Magnetic Stimulation (rTMS), which has demonstrated efficacy in reducing symptoms in psychiatric and neurological disorders. 3) Non-invasive neuromodulation therapies, such as median and radial nerve stimulation, which have been effective in improving motor and cognitive functions. These alternatives offer non-invasive, controlled interventions that can potentially mitigate stressors and improve cognitive and emotional outcomes in delirium patients.

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Behavioural Intervention

Digital Guided Meditation and Relaxation for Delirium (DREAMS Trial)

N/A

Waitlist Available

Led By Azra Bihorac, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

Age: < 18 years

Patient is intubated and cannot communicate.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily up to 14 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a digital system called D.R.E.A.M.S. that creates a calming environment for ICU patients. It aims to reduce stress by managing noise and light. The goal is to prevent delirium, a common issue in critically ill patients.

Who is the study for?

This trial is for adults over 18 years old at UF Health Shands Hospital who are not currently experiencing delirium. It's open to ICU patients unless they expect to stay less than a day, can't communicate due to intubation, have trouble using the tech equipment, severe cognitive issues like advanced dementia, or recent major brain events/surgery.

What is being tested?

The D.R.E.A.M.S. study tests if a high-tech guided meditation and relaxation system can help prevent mental and emotional problems that often happen after critical illness or being in intense medical environments which could lead to delirium.

What are the potential side effects?

Since this intervention involves technology-based meditation, side effects might be minimal but could include discomfort with wearing the equipment or possible stress from engaging with digital reality tools.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older, admitted to UF Health Shands Hospital, and not confused.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Select...

I am currently intubated and unable to speak.

Select...

I cannot use or wear the DREAMS equipment.

Select...

I was admitted to the ICU recently for a brain-related issue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily up to 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily up to 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily up to 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Blood Pressure -Systolic

Heart Rate

Secondary study objectives

Amount of sedatives requested by subjects

Amount of sedatives subjects receive

DREAMS usability and acceptability questionnaire

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mediation and Relaxation InterventionExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for delirium include pharmacological interventions like antipsychotics, which work by modulating neurotransmitter activity to reduce symptoms such as agitation and hallucinations. Non-pharmacological approaches, such as environmental modifications and cognitive therapies, aim to reduce stressors and improve orientation and cognitive function. The Immersive Digital Reality-Augmenting System (D.R.E.A.M.S.) aligns with these non-pharmacological strategies by providing a controlled, engaging environment that can mitigate stressors and enhance cognitive and emotional outcomes. This is crucial for delirium patients as it helps stabilize their mental state, reduces confusion, and promotes recovery without the side effects associated with medications.