Dementia AlzheimersNCT05265182
ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia
A study testing virtual reality in people with Dementia Alzheimers, run by Augmented eXperience E-health Laboratory at 1 site in Philippines.
Trial summary
The proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the first phase. Read more about this study
- Who is it for?
- Ages 40 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia Alzheimers
- What is being tested?
- virtual reality
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePhilippines
- Study dates
- 28 Apr 2022to 26 Jul 2022
- 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 40 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 40 to 59 years old
- Montreal Cognitive Assessment-Philippine Version (MoCA-P) score > 20
- Neuropsychiatric Inventory (NPI) score of 0
- Able to understand Filipino and English
Who cannot join
- Previously diagnosed with dementia
- Receptive aphasia
- Previously diagnosed with a psychiatric disorder
- Previously diagnosed with seizures or epilepsy
- Significant visual and hearing impairment
- Has a history of motion sickness
- Quadriplegia or paralysis of dominant hand
- Life expectancy of less than a year
Trial locations and contacts
1 site in 1 country.
Philippines1 site
College of Allied Medical Professions Clinic for Therapy Services
Manila, National Capital Region, 1000
About this study
Official title: Developing an Immersive Gamification Technology System (ImGTS) for the Management of Patients With Behavioral and Psychological Symptoms of Dementia (Phase 1 Trial)
The proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the first phase. The phase 1 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population.
Read the detailed description
The participants will undergo an intervention using the assigned ImGTS for four sessions (twice a week for two weeks), with a maximum of 45 minutes per session. VR trials are in 10- to 20-minute periods with introduction, orientation, and provisions for rest periods for patient comfort. During the experience, documentation of the patient's reaction and interaction with the ImGTS will be recorded by the researchers. The participants will be staying at the designated laboratory for not more than one hour.
Demographic characteristics Demographic characteristics of the participant (age, sex, educational attainment, marital status, living conditions, hobbies and interests, previous experience with VE applications, existing illnesses, medications) will be collected by the researchers through a questionnaire. Personal data, such as name and contact information, will only be collected to allow the investigators to contact the participants, as needed.
Safety Safety will be ensured by assessing a participant's experience of cybersickness. A cybersickness questionnaire, the Virtual Reality Sickness Questionnaire will be administered after each session. In this self-report questionnaire, nine symptoms will be rated as absent/none, slight, moderate, or severe. These symptoms are general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness when the eyes are closed, and vertigo. Answering the questionnaire will take around 10 minutes.
In the event that a participant will experience severe cybersickness, they may opt to discontinue the experience. They will be instructed to remove the HMD or to step out of the Semi-CAVE room to rest and recover from the symptoms. A medical professional will be present to monitor the participant's symptoms and to attend to them for further management. The reason(s) for discontinuing the experience will be documented.
Acceptability The acceptability of the design will be measured using the Place Probe, a sense of place questionnaire. The questionnaire will be administered after each session, and it will collect information on a participant's experience in the VE application, particularly on (a) their general impression of the environment, (b) the key features of the environment, and (c) their feelings of presence. A positive general impression, a memorable environment, and high level of presence will indicate that the VE developed is acceptable. This will take about 10 minutes to complete.
Usability Usability testing will be performed according to the PNS ISO/IEC Metrics. The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction. Additional usability metrics will be identified during the first phase of the study. The metrics will be specifically adjusted to the target participants as well as the contents to be included in the VR system.
- Conditions
- Dementia Alzheimers
- Being tested
- virtual reality
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityProcedure or surgery
Create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population initially, using semi-Cave or head-mounted display.
| Study group | Role | What they receive |
|---|---|---|
| Semi-CAVE | Experimental | The Semi-CAVE (Figure 2) will use two screens positioned at a corner of the room, each with a ceiling-mounted short throw projector in front. The user will sit in the middle of the area, giving them a viewing angle of roughly 180 degrees. The user will interact with the system through motion sensors positioned at the corners of the area. To one side of the area will be a sufficiently powerful computer running the software. The projectors will be connected to this computer via HDMI cables or similar. The Semi-CAVE may be offered as a solution for rehabilitation centers. Receives: Procedure: virtual reality |
| Head-mounted display or HMD | Experimental | The HMD will be a commercially available device that uses handheld controllers in addition to the head mounted apparatus, to control movement while in the VE. This device could provide a cheaper, more practical alternative to patients with mobility issues and environmental limitations brought about by the pandemic, since this can be used at home. Any patient, with supervision from their caregivers, will be able to use the applications using only the HMD system. Receives: Procedure: virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of cybersickness will be assessed using the Virtual Reality Sickness Questionnaire.
A 9-item Virtual Reality Sickness Questionnaire to assess cybersickness.
Measured: Immediately after each intervention, within an hour of completion of the virtual reality game.
The acceptability of the design will be measured using the Place Probe.
The Place Probe is a sense of place questionnaire.
Measured: Immediately after each intervention, within an hour of completion of the virtual reality game.
The rate of usability will be performed according to the Philippine National Standards ISO/IEC Metrics.
The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction.
Measured: Within an hour of the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start28 Apr 2022
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Dementia AlzheimersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- HMD and Semi-Cave
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augmented eXperience E-health Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veeda Michelle M Anlacan, MD, Principal investigator, University of the Philippines Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265182
- Sponsor's protocol ID
- AXEL0001
- Status last verified
- Jul 2022
- First submitted
- 14 Jan 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Appel L, Kisonas E, Appel E, Klein J, Bartlett D, Rosenberg J, Smith CN. Administering Virtual Reality Therapy to Manage Behavioral and Psychological Symptoms in Patients With Dementia Admitted to an Acute Care Hospital: Results of a Pilot Study. JMIR Form Res. 2021 Feb 3;5(2):e22406. doi: 10.2196/22406.
PubMed 33533720Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
PubMed 23961782Birckhead B, Khalil C, Liu X, Conovitz S, Rizzo A, Danovitch I, Bullock K, Spiegel B. Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study. JMIR Ment Health. 2019 Jan 31;6(1):e11973. doi: 10.2196/11973.
PubMed 30702436Clay F, Howett D, FitzGerald J, Fletcher P, Chan D, Price A. Use of Immersive Virtual Reality in the Assessment and Treatment of Alzheimer's Disease: A Systematic Review. J Alzheimers Dis. 2020;75(1):23-43. doi: 10.3233/JAD-191218.
PubMed 32280091Coelho T, Marques C, Moreira D, Soares M, Portugal P, Marques A, Ferreira AR, Martins S, Fernandes L. Promoting Reminiscences with Virtual Reality Headsets: A Pilot Study with People with Dementia. Int J Environ Res Public Health. 2020 Dec 12;17(24):9301. doi: 10.3390/ijerph17249301.
PubMed 33322679Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
PubMed 9153155Dominguez JC, Orquiza MG, Soriano JR, Magpantay CD, Esteban RC, Corrales ML, Ampil ER. Adaptation of the Montreal Cognitive Assessment for elderly Filipino patients. East Asian Arch Psychiatry. 2013 Sep;23(3):80-5.
PubMed 24088400Dominguez J, Fe de Guzman M, Reandelar M, Thi Phung TK. Prevalence of Dementia and Associated Risk Factors: A Population-Based Study in the Philippines. J Alzheimers Dis. 2018;63(3):1065-1073. doi: 10.3233/JAD-180095.
PubMed 29710725Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and psychological symptoms of dementia. BMJ. 2015 Mar 2;350:h369. doi: 10.1136/bmj.h369.
PubMed 25731881Kim O, Pang Y, Kim JH. The effectiveness of virtual reality for people with mild cognitive impairment or dementia: a meta-analysis. BMC Psychiatry. 2019 Jul 12;19(1):219. doi: 10.1186/s12888-019-2180-x.
PubMed 31299921Wong WT, Tan NC, Lim JE, Allen JC Jr, Lee WS, Quah JHM, Paulpandi M, Teh TA, Lim SH, Malhotra R. Comparison of Time Taken to Assess Cognitive Function Using a Fully Immersive and Automated Virtual Reality System vs. the Montreal Cognitive Assessment. Front Aging Neurosci. 2021 Nov 23;13:756891. doi: 10.3389/fnagi.2021.756891. eCollection 2021.
PubMed 34887743Manera V, Chapoulie E, Bourgeois J, Guerchouche R, David R, Ondrej J, Drettakis G, Robert P. A Feasibility Study with Image-Based Rendered Virtual Reality in Patients with Mild Cognitive Impairment and Dementia. PLoS One. 2016 Mar 18;11(3):e0151487. doi: 10.1371/journal.pone.0151487. eCollection 2016.
PubMed 26990298Mendez MF, Joshi A, Jimenez E. Virtual reality for the assessment of frontotemporal dementia, a feasibility study. Disabil Rehabil Assist Technol. 2015 Mar;10(2):160-4. doi: 10.3109/17483107.2014.889230. Epub 2014 Feb 14.
PubMed 24524440Moyle W, Jones C, Dwan T, Petrovich T. Effectiveness of a Virtual Reality Forest on People With Dementia: A Mixed Methods Pilot Study. Gerontologist. 2018 May 8;58(3):478-487. doi: 10.1093/geront/gnw270.
PubMed 28329867Optale G, Urgesi C, Busato V, Marin S, Piron L, Priftis K, Gamberini L, Capodieci S, Bordin A. Controlling memory impairment in elderly adults using virtual reality memory training: a randomized controlled pilot study. Neurorehabil Neural Repair. 2010 May;24(4):348-57. doi: 10.1177/1545968309353328. Epub 2009 Nov 24.
PubMed 19934445
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Immersive Gamification Technology System (ImGTS) for the Management of Patients With Behavioral and Psychological Symptoms of Dementia (Phase 1 Trial)
- ClinicalTrials.gov ID
- NCT05265182
- Acronym / sponsor ID
- AXEL0001
- Conditions
- Dementia Alzheimers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Augmented eXperience E-health LaboratoryUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 3 Mar 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 proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the first phase. The phase 1 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population.
Detailed description
The participants will undergo an intervention using the assigned ImGTS for four sessions (twice a week for two weeks), with a maximum of 45 minutes per session. VR trials are in 10- to 20-minute periods with introduction, orientation, and provisions for rest periods for patient comfort. During the experience, documentation of the patient's reaction and interaction with the ImGTS will be recorded by the researchers. The participants will be staying at the designated laboratory for not more than one hour.
Demographic characteristics Demographic characteristics of the participant (age, sex, educational attainment, marital status, living conditions, hobbies and interests, previous experience with VE applications, existing illnesses, medications) will be collected by the researchers through a questionnaire. Personal data, such as name and contact information, will only be collected to allow the investigators to contact the participants, as needed.
Safety Safety will be ensured by assessing a participant's experience of cybersickness. A cybersickness questionnaire, the Virtual Reality Sickness Questionnaire will be administered after each session. In this self-report questionnaire, nine symptoms will be rated as absent/none, slight, moderate, or severe. These symptoms are general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness when the eyes are closed, and vertigo. Answering the questionnaire will take around 10 minutes.
In the event that a participant will experience severe cybersickness, they may opt to discontinue the experience. They will be instructed to remove the HMD or to step out of the Semi-CAVE room to rest and recover from the symptoms. A medical professional will be present to monitor the participant's symptoms and to attend to them for further management. The reason(s) for discontinuing the experience will be documented.
Acceptability The acceptability of the design will be measured using the Place Probe, a sense of place questionnaire. The questionnaire will be administered after each session, and it will collect information on a participant's experience in the VE application, particularly on (a) their general impression of the environment, (b) the key features of the environment, and (c) their feelings of presence. A positive general impression, a memorable environment, and high level of presence will indicate that the VE developed is acceptable. This will take about 10 minutes to complete.
Usability Usability testing will be performed according to the PNS ISO/IEC Metrics. The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction. Additional usability metrics will be identified during the first phase of the study. The metrics will be specifically adjusted to the target participants as well as the contents to be included in the VR system.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- HMD and Semi-Cave
| Arm | Type | Receives |
|---|---|---|
| Semi-CAVE | Experimental | Procedure: virtual realityThe Semi-CAVE (Figure 2) will use two screens positioned at a corner of the room, each with a ceiling-mounted short throw projector in front. The user will sit in the middle of the area, giving them a viewing angle of roughly 180 degrees. The user will interact with the system through motion sensors positioned at the corners of the area. To one side of the area will be a sufficiently powerful computer running the software. The projectors will be connected to this computer via HDMI cables or similar. The Semi-CAVE may be offered as a solution for rehabilitation centers. |
| Head-mounted display or HMD | Experimental | Procedure: virtual realityThe HMD will be a commercially available device that uses handheld controllers in addition to the head mounted apparatus, to control movement while in the VE. This device could provide a cheaper, more practical alternative to patients with mobility issues and environmental limitations brought about by the pandemic, since this can be used at home. Any patient, with supervision from their caregivers, will be able to use the applications using only the HMD system. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 40 to 59 years old
- Montreal Cognitive Assessment-Philippine Version (MoCA-P) score > 20
- Neuropsychiatric Inventory (NPI) score of 0
- Able to understand Filipino and English
Key exclusion criteria (8 listed)
- Previously diagnosed with dementia
- Receptive aphasia
- Previously diagnosed with a psychiatric disorder
- Previously diagnosed with seizures or epilepsy
- Significant visual and hearing impairment
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 |
|---|---|---|
| virtual realityCreate an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population initially, using semi-Cave or head-mounted display. | Procedure or surgery | Head-mounted display or HMD, Semi-CAVE |
Primary outcome
The incidence of cybersickness will be assessed using the Virtual Reality Sickness Questionnaire.
Time frame: Immediately after each intervention, within an hour of completion of the virtual reality game.
A 9-item Virtual Reality Sickness Questionnaire to assess cybersickness.
The acceptability of the design will be measured using the Place Probe.
Time frame: Immediately after each intervention, within an hour of completion of the virtual reality game.
The Place Probe is a sense of place questionnaire.
The rate of usability will be performed according to the Philippine National Standards ISO/IEC Metrics.
Time frame: Within an hour of the end of the study.
The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 33533720Appel L, Kisonas E, Appel E, Klein J, Bartlett D, Rosenberg J, Smith CN. Administering Virtual Reality Therapy to Manage Behavioral and Psychological Symptoms in Patients With Dementia Admitted to an Acute Care Hospital: Results of a Pilot Study. JMIR Form Res. 2021 Feb 3;5(2):e22406. doi: 10.2196/22406.
- Background: PubMed 23961782Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
- Background: PubMed 30702436Birckhead B, Khalil C, Liu X, Conovitz S, Rizzo A, Danovitch I, Bullock K, Spiegel B. Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study. JMIR Ment Health. 2019 Jan 31;6(1):e11973. doi: 10.2196/11973.
- Background: PubMed 32280091Clay F, Howett D, FitzGerald J, Fletcher P, Chan D, Price A. Use of Immersive Virtual Reality in the Assessment and Treatment of Alzheimer's Disease: A Systematic Review. J Alzheimers Dis. 2020;75(1):23-43. doi: 10.3233/JAD-191218.
- Background: PubMed 33322679Coelho T, Marques C, Moreira D, Soares M, Portugal P, Marques A, Ferreira AR, Martins S, Fernandes L. Promoting Reminiscences with Virtual Reality Headsets: A Pilot Study with People with Dementia. Int J Environ Res Public Health. 2020 Dec 12;17(24):9301. doi: 10.3390/ijerph17249301.
- Background: PubMed 9153155Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
- Background: PubMed 24088400Dominguez JC, Orquiza MG, Soriano JR, Magpantay CD, Esteban RC, Corrales ML, Ampil ER. Adaptation of the Montreal Cognitive Assessment for elderly Filipino patients. East Asian Arch Psychiatry. 2013 Sep;23(3):80-5.
- Background: PubMed 29710725Dominguez J, Fe de Guzman M, Reandelar M, Thi Phung TK. Prevalence of Dementia and Associated Risk Factors: A Population-Based Study in the Philippines. J Alzheimers Dis. 2018;63(3):1065-1073. doi: 10.3233/JAD-180095.
- Background: PubMed 25731881Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and psychological symptoms of dementia. BMJ. 2015 Mar 2;350:h369. doi: 10.1136/bmj.h369.
- Background: PubMed 31299921Kim O, Pang Y, Kim JH. The effectiveness of virtual reality for people with mild cognitive impairment or dementia: a meta-analysis. BMC Psychiatry. 2019 Jul 12;19(1):219. doi: 10.1186/s12888-019-2180-x.
- Background: PubMed 34887743Wong WT, Tan NC, Lim JE, Allen JC Jr, Lee WS, Quah JHM, Paulpandi M, Teh TA, Lim SH, Malhotra R. Comparison of Time Taken to Assess Cognitive Function Using a Fully Immersive and Automated Virtual Reality System vs. the Montreal Cognitive Assessment. Front Aging Neurosci. 2021 Nov 23;13:756891. doi: 10.3389/fnagi.2021.756891. eCollection 2021.
- Background: PubMed 26990298Manera V, Chapoulie E, Bourgeois J, Guerchouche R, David R, Ondrej J, Drettakis G, Robert P. A Feasibility Study with Image-Based Rendered Virtual Reality in Patients with Mild Cognitive Impairment and Dementia. PLoS One. 2016 Mar 18;11(3):e0151487. doi: 10.1371/journal.pone.0151487. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
Veeda Michelle M Anlacan, MD principal investigator
University of the Philippines Manila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality in people with Dementia Alzheimers, run by Augmented eXperience E-health Laboratory at 1 site in Philippines.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 1 Feb 2023. 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 Philippines. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of cybersickness will be assessed using the Virtual Reality Sickness Questionnaire. (time frame: Immediately after each intervention, within an hour of completion of the virtual reality game.). The study lists 3 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 NCT05265182, which also lists 19 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 1 Feb 2023.