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NCT Number: NCT03385993

Digital Rehabilitation Environment Augmenting Medical System

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health

Gainesville, Florida, 32610, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Immediately before and after each intervention Up to 7 days

    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)

  2. Blood Pressure -Systolic

    Time frame: Immediately before and after each intervention up to 7 days

    Alterations to vital signs allow for Non-Verbal Pain assessments

  3. Heart Rate

    Time frame: Immediately before and after each intervention up to 7 days

    Alterations to vital signs allow for Non-Verbal Pain assessments

Secondary outcomes

  1. Respiratory Rate

    Time frame: Entire ICU stay up to 7 days

    Alterations to vital signs allow for Non-Verbal Pain assessments

  2. Patient pain perception

    Time frame: Immediately before and after each intervention up to 7 days

    Defense and Veterans Pain Rating Scale (DVPRS) Likert Scale 0 - 10, with 10 = severe pain (as bad as it could be. nothing else matters)

  3. Amount of sedatives requested by subjects

    Time frame: Entire ICU stay up to 7 days

    Richmond Agitation-Sedation Scale (RASS)- Patients with a RASS of -3 or less should have their sedation decreased or modified in order to achieve a RASS of -2 to 0. Patients with a RASS of 2 to 4 are not sedated enough and should be assessed for pain, anxiety, or delirium. The underlying etiology of the agitation should be investigated and appropriately treated to achieve a RASS of -2 to 0.

  4. Amount of sedatives subjects receive

    Time frame: Entire ICU stay up to 7 days

    Richmond Agitation-Sedation Scale (RASS)- Patients with a RASS of -3 or less should have their sedation decreased or modified in order to achieve a RASS of -2 to 0. Patients with a RASS of 2 to 4 are not sedated enough and should be assessed for pain, anxiety, or delirium. The underlying etiology of the agitation should be investigated and appropriately treated to achieve a RASS of -2 to 0.

  5. Subject's quality of sleep

    Time frame: Daily up to 14 days

    Richards-Campbell Sleep Questionnaire (RCSQ) five-item, visual analogue scale was designed as an outcome measure for assessing the perception of sleep in critically ill patients. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality.

  6. DREAMS usability and acceptability questionnaire

    Time frame: After each intervention up to 14 days

    A qualitative assessment of the usability and efficacy of the system Likert Scale 1-5, with 5 = strongly disagree.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: DREAMS

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Dec 29, 2017
Registry last updated
Jul 6, 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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