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Behavioural Intervention

Virtual Reality + Cognitive Training for Mild Cognitive Impairment

N/A
Recruiting
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 55 years
Chronic HF Stage C validated from echocardiography or comparable measure
Must not have
Major neurological disorder (e.g., previously diagnosed dementia, Parkinson's disease, epilepsy, multiple sclerosis)
Life-threatening unstable illness other than HF (e.g., end-stage cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Awards & highlights

Summary

This trial aims to improve the health, quality of life, and survival of older adults with heart failure and cognitive impairment by testing a dual-component intervention.

Who is the study for?
This trial is for adults over 55 with heart failure (Stage C) and mild cognitive issues, like memory or concentration problems. They must speak English and have someone to report on their daily activities. It's not for those with advanced heart failure, significant vision/hearing issues, major neurological/psychiatric conditions, life-threatening illnesses besides heart failure, or recent cognitive training.Check my eligibility
What is being tested?
The study tests a two-part treatment combining virtual reality-based cognitive restoration and computerized brain exercises to improve thinking skills and overall health in older adults with both heart failure and mild cognitive impairment.See study design
What are the potential side effects?
Since the interventions involve virtual reality experiences and computerized tasks designed to stimulate the brain, side effects might include discomfort from wearing VR headsets such as eye strain or dizziness but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 55 years old or older.
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My heart failure is at Stage C, confirmed by an echo test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a major neurological disorder like dementia or Parkinson's.
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I do not have a life-threatening illness other than heart failure.
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My heart failure is either at an early stage or very advanced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Cognition
Secondary outcome measures
Changes in health-related quality of life
Heart failure
Changes in instrumental activities of daily living
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Vita+Com (Both Vita and Com intervention)Experimental Treatment1 Intervention
Participants randomized to Vita+Com will receive both Vita and Com simultaneously. They will spend 10 minutes on Vita and then 1 hour on Com per day, 2-3 days/week for 8 weeks (a total of 23.3 hours). Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.
Group II: Vita (virtual reality-based cognitive restoration intervention)Experimental Treatment1 Intervention
Participants randomized to Vita will receive a virtual reality head-mount device (e.g., Oculus Quest) to view nature pictures for 10 minutes (1 set of 10 pictures)/day, 2-3 days/week for 8 weeks (a total of 20 sets for 200 minutes, approximately 3.3 hours) based on the provided activity schedule. Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.
Group III: Com (computerized cognitive training intervention )Experimental Treatment1 Intervention
Participants randomized to Com will receive a tablet computer (e.g., iPad) to complete BrainHQ training for 1 hour (6 exercises)/day, 2-3 days/week for 8 weeks (total of 20 hours) based on the provided activity schedule. Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.
Group IV: Usual careActive Control1 Intervention
Participants randomized to this control condition will continue to receive their usual care, but no interventions from the study team. We will monitor changes in their activities that may affect changes in cognitive function (e.g., starting book clubs) by weekly check-in calls during the 8 weeks of intervention phase.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
997 Previous Clinical Trials
1,095,422 Total Patients Enrolled
18 Trials studying Heart Failure
3,717 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,033,085 Total Patients Enrolled
42 Trials studying Heart Failure
213,127 Patients Enrolled for Heart Failure

Media Library

Virtual Reality and Computerized Cognitive Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05601817 — N/A
Heart Failure Research Study Groups: Vita (virtual reality-based cognitive restoration intervention), Com (computerized cognitive training intervention ), Vita+Com (Both Vita and Com intervention), Usual care
Heart Failure Clinical Trial 2023: Virtual Reality and Computerized Cognitive Intervention Highlights & Side Effects. Trial Name: NCT05601817 — N/A
Virtual Reality and Computerized Cognitive Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05601817 — N/A
~113 spots leftby Dec 2026
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