Digital Rehabilitation Environment Augmenting Medical System

Delirium Clinical Trial

— DREAMS  

Official title:

Digital Rehabilitation Environment Augmenting Medical System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03385993
• Other study ID #: IRB201703107
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 16, 2018
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Blood Pressure -Systolic	Alterations to vital signs allow for Non-Verbal Pain assessments	Immediately before and after each intervention up to 7 days
Primary	Heart Rate	Alterations to vital signs allow for Non-Verbal Pain assessments	Immediately before and after each intervention up to 7 days
Secondary	Respiratory Rate	Alterations to vital signs allow for Non-Verbal Pain assessments	Entire ICU stay up to 7 days
Secondary	Patient pain perception	Defense and Veterans Pain Rating Scale (DVPRS) Likert Scale 0 - 10, with 10 = severe pain (as bad as it could be. nothing else matters)	Immediately before and after each intervention up to 7 days
Secondary	Amount of sedatives requested by subjects	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.	Entire ICU stay up to 7 days
Secondary	Amount of sedatives subjects receive	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.	Entire ICU stay up to 7 days
Secondary	Subject's quality of sleep	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.	Daily up to 14 days
Secondary	DREAMS usability and acceptability questionnaire	A qualitative assessment of the usability and efficacy of the system Likert Scale 1-5, with 5 = strongly disagree.	After each intervention up to 14 days