NCT07802392

Brief Summary

This study aims to evaluate an immersive virtual reality program designed to support cognitive and emotional well-being in older adults with mild to moderate cognitive impairment. The program uses nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques. The goal is to determine whether immersive virtual reality can be a safe and effective tool to improve well-being and support active and healthy aging. The study will be conducted in two phases. In the first phase, virtual environments will be tested in healthy participants using behavioral and physiological measures. In the second phase, 200 older adults with cognitive impairment from day care centers and residential facilities will participate in a group-based immersive virtual reality intervention consisting of 10 sessions. Researchers will assess changes in cognitive function, emotional wellbeing, daily functioning, and quality of life before and after the intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 31, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 3, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

April 29, 2026

Last Update Submit

September 1, 2026

Conditions

Keywords

Immersive Virtual RealityCognitive ImpairmentOlder AdultsWell-beingQuality of LifeBlue and Green SpacesCognitive Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in cognitive function (verbal fluency and Digit Span tests)

    Cognitive function is assessed using verbal fluency tasks and Digit Span tests (forward and backward). Verbal fluency evaluates language and executive function by measuring the number of words generated under specific conditions. Digit Span forward assesses attention, while Digit Span backward assesses working memory. Higher scores indicate better cognitive performance.

    Baseline (pre-intervention) and immediately post-intervention (1 week)

Secondary Outcomes (6)

  • Change in anxiety symptoms (Generalized Anxiety Disorder 7-item scale [GAD-7])

    Baseline (pre-intervention) and immediately post-intervention (1 week)

  • Short-form Yesavage Geriatric Depression Scale (GDS-SF)

    Baseline (pre-intervention) and immediately post-intervention (1 week)

  • Change in positive and negative affect (Positive and Negative Affect Schedule-10 [PANAS-10])

    Baseline (pre-intervention) and immediately post-intervention (1 week)

  • Change in loneliness (UCLA Loneliness Scale, UCLA-10)

    Baseline (pre-intervention) and immediately post-intervention (1 week)

  • Change in quality of life (EuroQol 5-Dimension 5-Level questionnaire [EQ-5D-5L])

    Baseline (pre-intervention) and immediately post-intervention (1 week)

  • +1 more secondary outcomes

Other Outcomes (3)

  • Perceived immersion during virtual reality sessions (Self-Assessment Manikin, SAM)

    At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.

  • Participant satisfaction with immersive virtual reality sessions

    At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.

  • Intervention adherence based on session attendance and completion rates

    At the end of each intervention day: Day 1 (after session 4), Day 2 (after session 7), and Day 3 (after session 10).

Study Arms (1)

Immersive virtual reality intervention

EXPERIMENTAL

Participants receive a group-based immersive virtual reality intervention consisting of 10 sessions using nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques.

Device: Immersive virtual reality program

Interventions

Participants receive an immersive virtual reality intervention using nature-based environments. The program consists of 10 group sessions that combine mindfulness, cognitive stimulation, and breathing techniques to promote cognitive and emotional well-being.

Immersive virtual reality intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 65 years
  • Diagnosis of mild or moderate cognitive impairment
  • Ability to understand study procedures and follow instructions
  • Ability to provide informed consent (or consent provided by a legal representative)
  • Attendance at participating day care centers or residential facilities (Phase 2)
  • For Phase 1: healthy adults without cognitive impairment

You may not qualify if:

  • Severe cognitive impairment or diagnosis of advanced dementia
  • Severe visual, auditory, or motor impairments that prevent use of virtual reality
  • Neurological or psychiatric conditions that may interfere with participation
  • History of epilepsy or conditions contraindicating virtual reality exposure
  • Severe behavioral disturbances or agitation
  • Participation in other clinical studies that may interfere with results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Maite Garolera, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Neuropsychological Unit and Director of the Brain, Cognition, and Behavior Research Group

Study Record Dates

First Submitted

April 29, 2026

First Posted

September 3, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 3, 2026

Record last verified: 2026-05

Locations