Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-04-30
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study focuses on improving the quality of life of older healthy people by facilitating cognitive training through VR. Healthy people aged 65-85 will be eligible for the project. If the participants meet the inclusion criteria, they will be invited to participate in the study and be provided with detailed information about the research project. Based on sample size calculations, up to two hundred (200) older adults are intended to be included in the project. The participants will use specially designed VR systems and activities aimed at improving their cognitive abilities.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
NCT03605017
Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention
NCT05583903
Virtual Reality Training for Inhibitory Control in Neurocognitive Disorders
NCT06597591
Computerized Virtual Reality in Elderly
NCT04984694
Virtual Reality Training Intervention on Cognitive Function and Quality of Life
NCT05329272
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The CNS-Vital Signs, a computerized neuropsychological battery, will be used to assess primary outcomes (Working Memory and Complex Attention), and will be administered to the participants before the intervention and after 36 training sessions. Differences in performance on primary and secondary outcomes will be analyzed with a Linear Mixed Model Analysis of Variance for longitudinal outcomes. Measures of anxiety and well-being will also be registered.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
The data gathered before and after the intervention will be sent to an external statistical analyst blinded to group assignment.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VR training
VR training for at least 10 minutes at least three days per week, resulting in a total of at least 36 sessions (at least \~12 hours of training in total) for each participant, spread across three months. Each session will focus on cognitive training.
VR training
The intervention group will receive cognitive training through VR headsets three times a week for 12 weeks. The intervention will be delivered in a virtual setting using images and music. The participants will be allowed to select the type of music and virtual environment during the intervention. The intervention will include four modules targeting attention and working memory through immersive VR.
VR activity
VR activity for at least 10 minutes at least three days per week, resulting in a total of at least 36 sessions (at least \~12 hours of training in total) for each participant, spread across three months, with 360º images and videos but without the interactive cognitive training.
VR activity
High-quality 360º images and videos from natural environments, such as a relaxing mountain environment. The participants in the control group will not receive cognitive training.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VR training
The intervention group will receive cognitive training through VR headsets three times a week for 12 weeks. The intervention will be delivered in a virtual setting using images and music. The participants will be allowed to select the type of music and virtual environment during the intervention. The intervention will include four modules targeting attention and working memory through immersive VR.
VR activity
High-quality 360º images and videos from natural environments, such as a relaxing mountain environment. The participants in the control group will not receive cognitive training.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Undisturbed locomotion
* Do not require care or help from others in their everyday functioning
* Are able to go on long walks unassisted
* Are able to use common modern technology unassisted (e.g. using a smartphone to send a message)
Exclusion Criteria
* Abuse or addiction to alcohol, drugs and tranquilizers
* Blurred vision that cannot be corrected with lenses or glasses that fit under the VR headset
* Auditory pathologies causing a significant decrease in hearing unaided
* High sensitivity to motion sickness
* Proneness to migraines
* Subject epileptic
* Subject vulnerable
* Subject obese or frail, as assessed based on their Body Mass Index (BMI)
* Subject considered by the study investigator to be an unsuitable candidate to participate in the study, due to other relevant reasons
65 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Center for Research and Development, Poland
OTHER
Senopi AG
UNKNOWN
Medical University of Lodz
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jakub Kazmierski
Assoc. Prof. MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jakub M Kaźmierski, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Lodz, Poland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
Lodz, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Szczepocka E, Mokros L, Kazmierski J, Nowakowska K, Lucka A, Antoszczyk A, Oltra-Cucarella J, Werzowa W, Hellevik MM, Skouras S, Bagger K. The Effectiveness of Virtual Reality-Based Training on Cognitive, Social, and Physical Functioning in High-Functioning Older Adults (CoSoPhy FX): 2-Arm, Parallel-Group Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 5;13:e53261. doi: 10.2196/53261.
Szczepocka E, Mokros L, Kazmierski J, Nowakowska K, Lucka A, Antoszczyk A, Oltra-Cucarella J, Werzowa W, Hellevik M, Skouras S, Bagger K. Virtual reality-based training may improve visual memory and some aspects of sustained attention among healthy older adults - preliminary results of a randomized controlled study. BMC Psychiatry. 2024 May 8;24(1):347. doi: 10.1186/s12888-024-05811-2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RNN/222/21/KE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.