Virtual RealityNCT05369897
VR for Improving Attention and Working Memory
A study testing VR training and VR activity in people with Virtual Reality, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The main objective of the study is to investigate the effects of using a set of Virtual Reality (VR)-based Digital Therapeutics (DTx) apps to improve the cognitive abilities of healthy (high-functioning) seniors. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- VR training and VR activity
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 30 Apr 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy or in a stable medical condition
- 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)
Who cannot join
- Presence of neuropsychiatric disorders, including mild cognitive impairment (MCI) - Montreal Cognitive Assessment (MoCA) score <26 points
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
Lodz, 92-213
Jakub Kaźmierski, PhD, 0048426757232, jakub.kazmierski@umed.lodz.pl
About this study
Official title: Benefits of a Virtual Reality Based Cognitive Intervention for Attention and Working Memory
The main objective of the study is to investigate the effects of using a set of Virtual Reality (VR)-based Digital Therapeutics (DTx) apps to improve the cognitive abilities of healthy (high-functioning) seniors. For the purposes of the study, high-functioning seniors are defined as being over the age of 65 years, while maintaining their functional independence with regards to activities of daily living, including the ability to go on a long walk and the ability to interact with common modern technology (e.g. using a smartphone to send a message).
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.
Read the detailed description
The participants that meet inclusion criteria will be randomly assigned to the experimental group or the control group. The participants in the experimental group will receive a cognitive intervention focused on attention and working memory through virtual reality handsets. The intervention will be delivered at home and monitored by the research team via wifi. The participants will be required to perform the cognitive training at least 3 times a week for 12 weeks (36 training sessions). The participants in the control group will see high definition images through VR handsets without cognitive training.
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
- Virtual Reality
- Being tested
- VR training, VR activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR trainingDevice
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 activityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VR training | Experimental | 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. Receives: Device: VR training |
| VR activity | Sham comparator | 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. Receives: Device: VR activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory
Assessed with the "Working Memory" domain from the CNS Vital Signs (CNSVS) computerized neuropsychological battery. The range of scores is from 0 to 38, with higher scores indicating better performance.
A positive change after the intervention corresponds to an improvement in performace from baseline to follow-up.
Measured: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Attention
Assessed with the "Complex Attention" domain from the CNS Vital Signs (CNSVS) computerized neuropsychological battery. The range of scores is from 0 to 76, with higher scores indicating better performance.
A positive change after the intervention corresponds to an improvement in performace from baseline to follow-up.
Measured: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Secondary outcomes (5)
Cognitive functioning
Assessment of cognitive performance across a wide range of cognitive subdomains on the CNS Vital Signs (CNSVS) computerized battery (composite memory, verbal memory, visual memory, psychomotor speed, reaction time, cognitive flexibility, processing speed, executive function, simple attention, motor speed). The range of scores is from 0 to 40 (depending on the test), with higher scores indicating better performance.
A positive change after the intervention corresponds to an improvement in performace from baseline to follow-up.
Measured: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Standard grip strength measurement using a dynamometer
Assessment of grip strength as a key frailty indicator. The range of scores is from 0 to 90, with higher scores indicating higher grip strength.
A positive change after the intervention corresponds to an improvement in performace from baseline to follow-up.
Measured: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
The quality of life and the level of perceived well-being
Assessment of the quality of life and the level of perceived well-being by using the World Health Organization 5 Well-Being Index. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
A positive change after the intervention corresponds to an improvement in well-being from baseline to follow-up.
Measured: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Severity of anxiety symptoms
Assessment of the severity of anxiety symptoms by using Generalized Anxiety Disorder Questionnaire (GAD-7). The range of scores is from 0-21, with higher scores suggesting more severe ansiety symptoms.
A positive change after the intervention corresponds to an increase in anxiety symptoms from baseline to follow-up.
Measured: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Health-related quality of life
Assessment of the quantify the health-related quality of life by using the 5-level Euroquol 5D (EQ-5D-5L) questionnaire.
The EQ-5D-5L questionnaire has 5 dimensions, each with 5 levels of perceived problems describing 3125 distinct health states: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4), and extreme problems (level 5). EQ-5D-5L is a widely used measure of health-related quality of life.
A positive change in the level of problems corresponds to an increase in the severity of symptoms from baseline to follow-up.
Measured: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start30 Apr 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research and Development, Poland, Senopi AG
- Responsible party
- Principal investigator, Jakub Kazmierski, Medical University of Lodz
- Investigators
- Jakub M Kaźmierski, PhD, Principal investigator, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369897
- Sponsor's protocol ID
- RNN/222/21/KE
- Status last verified
- Jun 2022
- First submitted
- 21 Apr 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the first publication is publicly accessible, the anonymous data generated will be made available for sharing upon request. Shared data will include demographics, primary and secondary outcomes, and VR usability data. A committee of experts within the study team will discuss and decide whether data sharing is appropriate, based on the novelty and scientific rigor of the proposal. Applicants will be asked to sign a data access agreement to ensure a commitment to using the data only for research purposes and to securing the data with appropriate procedures. Redistribution of the data to other third parties will not be allowed.
Publications
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.
PubMed 38837194Szczepocka 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.
PubMed 38720251
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a Virtual Reality Based Cognitive Intervention for Attention and Working Memory
- ClinicalTrials.gov ID
- NCT05369897
- Acronym / sponsor ID
- RNN/222/21/KE
- Conditions
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- National Center for Research and Development, Poland, Senopi AG
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to investigate the effects of using a set of Virtual Reality (VR)-based Digital Therapeutics (DTx) apps to improve the cognitive abilities of healthy (high-functioning) seniors. For the purposes of the study, high-functioning seniors are defined as being over the age of 65 years, while maintaining their functional independence with regards to activities of daily living, including the ability to go on a long walk and the ability to interact with common modern technology (e.g. using a smartphone to send a message).
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.
Detailed description
The participants that meet inclusion criteria will be randomly assigned to the experimental group or the control group. The participants in the experimental group will receive a cognitive intervention focused on attention and working memory through virtual reality handsets. The intervention will be delivered at home and monitored by the research team via wifi. The participants will be required to perform the cognitive training at least 3 times a week for 12 weeks (36 training sessions). The participants in the control group will see high definition images through VR handsets without cognitive training.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR training | Experimental | Device: VR trainingVR 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 activity | Sham comparator | Device: VR activityVR 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Healthy or in a stable medical condition
- 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)
Key exclusion criteria (10 listed)
- Presence of neuropsychiatric disorders, including mild cognitive impairment (MCI) - Montreal Cognitive Assessment (MoCA) score <26 points
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR trainingThe 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. | Device | VR training |
| VR activityHigh-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. | Device | VR activity |
Primary outcome
Working memory
Time frame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Assessed with the "Working Memory" domain from the CNS Vital Signs (CNSVS) computerized neuropsychological battery. The range of scores is from 0 to 38, with higher scores indicating better performance. A positive change after the intervention corresponds to an improvement in performace from baseline to follow-up.
Attention
Time frame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Assessed with the "Complex Attention" domain from the CNS Vital Signs (CNSVS) computerized neuropsychological battery. The range of scores is from 0 to 76, with higher scores indicating better performance. A positive change after the intervention corresponds to an improvement in performace from baseline to follow-up.
5 secondary outcomes
Cognitive functioning
Time frame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Standard grip strength measurement using a dynamometer
Time frame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
The quality of life and the level of perceived well-being
Time frame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Severity of anxiety symptoms
Time frame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Health-related quality of life
Time frame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Derived from this study: PubMed 38837194Szczepocka 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.
- Derived from this study: PubMed 38720251Szczepocka 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.
- Individual participant dataSharing planned: Yes. Once the first publication is publicly accessible, the anonymous data generated will be made available for sharing upon request. Shared data will include demographics, primary and secondary outcomes, and VR usability data. A committee of experts within the study team will discuss and decide whether data sharing is appropriate, based on the novelty and scientific rigor of the proposal. Applicants will be asked to sign a data access agreement to ensure a commitment to using the data only for research purposes and to securing the data with appropriate procedures. Redistribution of the data to other third parties will not be allowed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakub M Kaźmierski, PhD principal investigator
Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR training and VR activity in people with Virtual Reality, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jakub M Kaźmierski, PhD (426757232 ext. 0048, jakub.kazmierski@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working memory (time frame: Change in scores between pre-intervention (baseline) and post-intervention (after 3 months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05369897, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.