NCT05601817 · ACTIVE NOT RECRUITING

Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure

This trial is testing three behavioral interventions for older adults who have both heart failure and mild cognitive impairment: a virtual reality cognitive restoration program, a computerized cognitive training program, and a combination of both. Researchers want to know which approach best supports cognitive function and overall health. This is a Phase NA trial, meaning it is a practical intervention study rather than a traditional drug trial phase.

Eligibility criteria

We will use a two-step process to screen and enroll the patients. First, we will screen potentially eligible patients from the Indiana University Health systems using these eligibility criteria.
Inclusion Criteria:
1. ≥ 55 years;
2. chronic HF Stage C validated from echocardiography or comparable measure or B-type natriuretic peptide (BNP) level > 400 pg/ml [or equivalent NT-proBNP] in past 3 years;
3. ability to communicate in English;
4. capacity to consent according to the Indiana University Institutional Review Board policies, or lacks capacity to consent but has the ability to provide assent from someone who can serve as LAR; and
5. Subjectively reported cognitive concern assessed by the question, "Do you have any trouble with your memory or thinking?".
Exclusion Criteria:
1. pre-HF (Stages A and B) or advanced HF (Stage D);
2. vision or hearing problems that can interfere with cognitive testing;
3. major neurological disorder (e.g., previously diagnosed dementia, Parkinson's disease, epilepsy, multiple sclerosis);
4. major psychiatric disease (e.g., schizophrenia, bipolar disorder);
5. life-threatening unstable illness other than HF (e.g., end-stage cancer); and
6. users of regular computerized cognitive training or participants in cognitive training trials in the past year.
Second, we will enroll patients only if they have MCI or normal cognition by not meeting criteria for dementia.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-03-23

View full record on ClinicalTrials.gov

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