Cognitive ImpairmentiEMBRACENCT06693193
Personalized Virtual Environments for Managing Responsive Behaviors in Cognitively Impaired Patients: a Feasibility Study
A study testing Immersive Virtual Reality in people with Cognitive Impairment and Dementia, run by Fondazione Bruno Kessler at 1 site in Italy.
Trial summary
The goal of this feasibility study is to explore the feasibility of using realistic, customizable virtual reality (VR) environments in response to the onset of Responsive Behaviors in elderly residents with cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment, Dementia
- What is being tested?
- Immersive Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years of age.
- Native Italian speakers.
- Can provide written informed consent for study participation or have a legal guardian who can give consent on their behalf.
Who cannot join
- Presence of any psychiatric diagnoses as recorded in medical records.
- A total score of ≥ 40 on the Neuropsychiatric Inventory (NPI) indicates neuropsychiatric symptoms.
- A partial NPI score > 6 in the domains of agitation/aggression or delusions.
- Enrollment in palliative care services.
- Severe neurological damage, a positive diagnosis of epilepsy, or having first-degree relatives diagnosed with epilepsy.
- Presence of a cardiac pacemaker or other metallic devices.
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- Infectious or gastrointestinal disorders.
- Open facial wounds, motor or visual impairments, or neuromuscular pain that would prevent using the Oculus VR headset.
- Refusal to consent, either by the individual or their legal representative, for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lorenzo Gios contact
Italy1 site
APSP ''Grazioli''
Trento, Italy, 38123
Lucia Leonardelli, + 0461818181, info@apspgrazioli.it
Susanna Pardini
About this study
Official title: Personalized Virtual Environments for Patients with Cognitive Impairment Exhibiting Responsive Behaviors: Proof-of-Concept and Feasibility Study
The goal of this feasibility study is to explore the feasibility of using realistic, customizable virtual reality (VR) environments in response to the onset of Responsive Behaviors in elderly residents with cognitive impairment.
Specifically, the study will assess;
Read more
- feasibility through acceptance metrics (including recruitment rate, adherence rate, attrition rate, and tolerance to the intervention);
- safety (monitoring for adverse effects related to VR headset use);
- user engagement, enjoyment, and overall experience.
Participants will be exposed to three VR sessions conducted before, during, or after a situation deemed activating (e.g., personal hygiene activities). Operators will conduct a baseline assessment to identify specific moments when the participant experiences responsive behaviors. Additionally, operators may administer the Oculus VR headset when responsive behaviors occur outside of baseline-identified moments.
Read the detailed description
Study Site and Environment: Data collection will occur at the Azienda Pubblica di Servizi alla Persona "Margherita Grazioli" in Povo, Trento. The experimental setup will be free from external interference to minimize distractions and ensure a smooth study process. The study will be conducted in familiar, ecologically relevant settings within APSP, selecting environments likely to stimulate activation states in participants.
Duration and Procedure: The study is expected to last six months. Each participant will undergo at least three VR sessions about situations that may trigger activation, such as personal hygiene activities. A baseline assessment will pinpoint specific times when participants exhibit responsive behaviors. Additionally, VR sessions may be initiated if responsive behaviors arise outside the predicted times using the Oculus headset.
Procedure and Timing for Each VR Session:
Preliminary Assessment (Participant Selection) (~30 minutes):
Participants are selected based on inclusion/exclusion criteria and provided with informed consent.
Information is collected from clinical records and updated based on the participant's condition.
An initial assessment examines responsive behaviors' type, frequency, and timing using demographic information, FAST, NPI, and CMAI.
Pre-Session Evaluation (T0) (~15 minutes):
Assessments include pain, responsive behaviors, emotions, anxiety, pleasantness, and discomfort before VR use (using PAINAD and STAI-Y1).
Virtual Environment Selection (~5 minutes):
The operator selects the VR environment for the participant through a smartphone linked to the Oculus headset via WiFi.
Procedure Explanation and Contextualization (~5 minutes):
A brief overview of the session and VR setup is provided to the participant.
Familiarization with Oculus Headset (~1-2 minutes):
A brief period to help the participant acclimate to the VR headset.
VR Session and During-Session Evaluation (T1) (~8 minutes within tolerance):
The VR session is audio-visual recorded, with the operator noting participant behaviors and responses (using OERS, Observation Sheet, STAI-Y1, Ad Hoc Questionnaire, PAINAD, and DataSheet2).
Post-Session Evaluation (T2) (~15 minutes):
Pain, responsive behaviors, emotions, anxiety, pleasantness, and discomfort are re-evaluated (using PAINAD, DataSheet2, Ad Hoc Questionnaire, STAI-Y1, OERS, NPT-ES, and VRSQ).
Final Evaluation (T3) (~10 minutes):
After all sessions, a final assessment using the Cohen-Mansfield Agitation Inventory (CMAI) is conducted.
- Conditions
- Cognitive Impairment, Dementia
- Being tested
- Immersive Virtual Reality
- Keywords
- Customization, Customized Virtual Reality Scenarios, Cognitive Impairment, Responsive Behaviors, Virtual Reality Therapy, Non pharmacological therapy
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityDevice
Individuals will participate in three VR sessions using Oculus headsets, experiencing virtual environments featuring realistic natural stimuli or custom settings tailored to their preferences and valued activities. Each environment allows for the adjustment of auditory elements (such as animal sounds, rustling wind, or specific music), visual elements (such as people, objects, or animals), and the time of day and weather conditions. The operator will use a user-friendly smartphone app to customize the environment, making real-time adjustments to settings and content. Throughout the VR experience, the operator can monitor the participant's visual focus in real-time.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality group | Experimental | Participants will undergo three VR exposure sessions using Oculus headsets, presenting a virtual environment with realistic natural stimuli or customized environments tailored to individual preferences and valued activities. For each environment, auditory (e.g., animal sounds, wind rustling, type of music) and visual elements (e.g., presence of people, objects, or animals), as well as time of day and weather conditions, can be adjusted. The operator will customize the environment through a user-friendly smartphone app interface, enabling real-time parameter adjustments and content selection. During VR exposure, the operator can observe the participant's visual focus in real-time. Receives: Device: Immersive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility based on the health staff operator perspective using the System Usability Scale (SUS)
The SUS scale permitted the obtaining of information about the system's usability. The SUS range raw score from 0 to 100.
Measured: From enrollment to the end of treatment at 3 weeks
Feasibility using an Ad-hoc questionnaire
The ad-hoc questionnaire permitted information about usability, engagement, satisfaction, and pleasure during exposure to the VR environment, as well as feelings and relaxation. The questionnaire is composed of 30 items based on a Likert scale from 1 to 5 (range score from 0 to 4), 15 items based on a Likert scale from 1 to 4 (range score from 0 to 3), and five open-ended questions.
Measured: From enrollment to the end of treatment at 3 weeks
Feasibility using the Non-pharmacological Therapy Experience Scale (NPT-ES)
The NPT-ES permitted obtaining information about the subjective experience during the administration of non-pharmacological therapy. Five items are assessed on a Likert scale from 0 to 3. The total raw score is from 0 to 15.
Measured: From enrollment to the end of treatment at 3 weeks
Feasibility based on the health staff operator perspective using Focus Groups
Measured: From enrollment to the end of treatment at 3 weeks
Secondary outcomes (7)
Assessment of the Responsive Behaviors administering the COHEN MANSFIELD - AGITATION INVENTORY (CMAI)
The CMAI was permitted to obtain information about the frequencies of 29 different responsive behaviors based on a Likert scale from 0 to 6. The total raw score is from 0 to 174.
Measured: From enrollment to the end of treatment at 3 weeks
Assessment of the Responsive Behaviors administering the Functional Assessment Staging Tool (FAST)
The FAST is a scale that permits the definition of the severity of functional impairment related to a diagnosis of cognitive impairment. It comprises seven degrees of severity and is assessed by the clinical health staff based on the anamnestic information.
Measured: From enrollment to the end of treatment at 3 weeks
Investigation of Adverse Symptoms Associated with Exposure to the Virtual Reality Device using the Virtual Reality Symptoms Questionnaire (VRSQ)
The VRSQ assesses the general and eye-related physical symptoms of exposure to a virtual reality environment. The score assigned to each item ranges from 0 to 6, with a maximum total score of 84 (48 for general symptoms and 36 for eye symptoms). Higher scores represent worse symptoms, with 0 corresponding to no adverse effects and 84 to serious adverse effects.
Measured: From enrollment to the end of treatment at 3 weeks
Pain experience assessment using the Pain Assessment in Advanced Dementia (PAINAD)
The PAINAD provides a method of analyzing the pain experienced by people with dementia. The total score ranges from 0-10 points.
Measured: From enrollment to the end of treatment at 3 weeks
Assessment of the pharmacotherapy administration and the users'behaviors before or during the VR sessions using the DataSheet 2
DataSheet 2 permits obtaining information about the administration of pharmacotherapy before, during, or after the VR exposure based on three open-ended questions filled out by the health staff operator that administers the experimental procedure. Moreover, the scale permitted information about the user's behavior during the VR exposure to be assessed by the health staff operator based on five questions on a Likert scale from 0 to 3 (Total raw score from 0 to 15).
Measured: From enrollment to the end of treatment at 3 weeks
Assessment of the state-anxiety using the State-Trait Anxiety Inventory-Y1 (STAI-Y1)
The modified version of the (STAI-Y1), inspired by Appel et al.2021, was administered in this study to obtain information on the state-anxiety level and other types of emotions individuals experienced before and after the VR session. The current study will investigate relaxation, worry/anxiety, sadness, tightness, annoyance, and anger explicitly. The scale is administered as an interview based on a 5-point Likert scale from 1 (not at all) to 5 (a lot).
Measured: From enrollment to the end of treatment at 3 weeks
Emotional and behavioral assessment using the Observed Emotion Rating Scale (OERS)
The OERS assess the presence and frequency of negative emotions (fear, anxiety, anger, and sadness) and positive (pleasure) feelings experienced during the session based on a scale from 1 to 5 (1: "undetected emotion"; 2: "emotion observed for less than 16 s"; 3: "emotion observed for 16-59 s"; 4: "emotion observed for 1-5 min"; 5: "emotion observed for more than 5 min").
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Bruno Kessler
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanna Pardini, Fondazione Bruno Kessler
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693193
- Sponsor's protocol ID
- VR2024
- Acronym
- iEMBRACE
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pardini S, Gios L, Dianti M, Genovese A, Lamon M, Marcon J, Forti S, Mayora-Ibarra O. Exploring customised virtual environments in patients with cognitive decline and responsive behaviours: protocol for a proof-of-concept and feasibility study in a long-term care facility (iEMBRACE). BMJ Open. 2025 Dec 5;15(12):e098051. doi: 10.1136/bmjopen-2024-098051.
PubMed 41360455
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Virtual Environments for Patients with Cognitive Impairment Exhibiting Responsive Behaviors: Proof-of-Concept and Feasibility Study
- ClinicalTrials.gov ID
- NCT06693193
- Acronym / sponsor ID
- iEMBRACE / VR2024
- Conditions
- Cognitive Impairment, Dementia
- Keywords
- Customization, Customized Virtual Reality Scenarios, Cognitive Impairment, Responsive Behaviors, Virtual Reality Therapy, Non pharmacological therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione Bruno KesslerUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 18 Nov 2024 (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 goal of this feasibility study is to explore the feasibility of using realistic, customizable virtual reality (VR) environments in response to the onset of Responsive Behaviors in elderly residents with cognitive impairment.
Specifically, the study will assess;
- feasibility through acceptance metrics (including recruitment rate, adherence rate, attrition rate, and tolerance to the intervention);
- safety (monitoring for adverse effects related to VR headset use);
- user engagement, enjoyment, and overall experience.
Participants will be exposed to three VR sessions conducted before, during, or after a situation deemed activating (e.g., personal hygiene activities). Operators will conduct a baseline assessment to identify specific moments when the participant experiences responsive behaviors. Additionally, operators may administer the Oculus VR headset when responsive behaviors occur outside of baseline-identified moments.
Detailed description
Study Site and Environment: Data collection will occur at the Azienda Pubblica di Servizi alla Persona "Margherita Grazioli" in Povo, Trento. The experimental setup will be free from external interference to minimize distractions and ensure a smooth study process. The study will be conducted in familiar, ecologically relevant settings within APSP, selecting environments likely to stimulate activation states in participants.
Duration and Procedure: The study is expected to last six months. Each participant will undergo at least three VR sessions about situations that may trigger activation, such as personal hygiene activities. A baseline assessment will pinpoint specific times when participants exhibit responsive behaviors. Additionally, VR sessions may be initiated if responsive behaviors arise outside the predicted times using the Oculus headset.
Procedure and Timing for Each VR Session:
Preliminary Assessment (Participant Selection) (~30 minutes):
Participants are selected based on inclusion/exclusion criteria and provided with informed consent.
Information is collected from clinical records and updated based on the participant's condition.
An initial assessment examines responsive behaviors' type, frequency, and timing using demographic information, FAST, NPI, and CMAI.
Pre-Session Evaluation (T0) (~15 minutes):
Assessments include pain, responsive behaviors, emotions, anxiety, pleasantness, and discomfort before VR use (using PAINAD and STAI-Y1).
Virtual Environment Selection (~5 minutes):
The operator selects the VR environment for the participant through a smartphone linked to the Oculus headset via WiFi.
Procedure Explanation and Contextualization (~5 minutes):
A brief overview of the session and VR setup is provided to the participant.
Familiarization with Oculus Headset (~1-2 minutes):
A brief period to help the participant acclimate to the VR headset.
VR Session and During-Session Evaluation (T1) (~8 minutes within tolerance):
The VR session is audio-visual recorded, with the operator noting participant behaviors and responses (using OERS, Observation Sheet, STAI-Y1, Ad Hoc Questionnaire, PAINAD, and DataSheet2).
Post-Session Evaluation (T2) (~15 minutes):
Pain, responsive behaviors, emotions, anxiety, pleasantness, and discomfort are re-evaluated (using PAINAD, DataSheet2, Ad Hoc Questionnaire, STAI-Y1, OERS, NPT-ES, and VRSQ).
Final Evaluation (T3) (~10 minutes):
After all sessions, a final assessment using the Cohen-Mansfield Agitation Inventory (CMAI) is conducted.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality group | Experimental | Device: Immersive Virtual RealityParticipants will undergo three VR exposure sessions using Oculus headsets, presenting a virtual environment with realistic natural stimuli or customized environments tailored to individual preferences and valued activities. For each environment, auditory (e.g., animal sounds, wind rustling, type of music) and visual elements (e.g., presence of people, objects, or animals), as well as time of day and weather conditions, can be adjusted. The operator will customize the environment through a user-friendly smartphone app interface, enabling real-time parameter adjustments and content selection. During VR exposure, the operator can observe the participant's visual focus in real-time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 18 years of age.
- Native Italian speakers.
- Can provide written informed consent for study participation or have a legal guardian who can give consent on their behalf.
Key exclusion criteria (9 listed)
- Presence of any psychiatric diagnoses as recorded in medical records.
- A total score of ≥ 40 on the Neuropsychiatric Inventory (NPI) indicates neuropsychiatric symptoms.
- A partial NPI score > 6 in the domains of agitation/aggression or delusions.
- Enrollment in palliative care services.
- Severe neurological damage, a positive diagnosis of epilepsy, or having first-degree relatives diagnosed with epilepsy.
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 |
|---|---|---|
| Immersive Virtual RealityIndividuals will participate in three VR sessions using Oculus headsets, experiencing virtual environments featuring realistic natural stimuli or custom settings tailored to their preferences and valued activities. Each environment allows for the adjustment of auditory elements (such as animal sounds, rustling wind, or specific music), visual elements (such as people, objects, or animals), and the time of day and weather conditions. The operator will use a user-friendly smartphone app to customize the environment, making real-time adjustments to settings and content. Throughout the VR experience, the operator can monitor the participant's visual focus in real-time. | Device | Virtual Reality group |
Primary outcome
Feasibility based on the health staff operator perspective using the System Usability Scale (SUS)
Time frame: From enrollment to the end of treatment at 3 weeks
The SUS scale permitted the obtaining of information about the system's usability. The SUS range raw score from 0 to 100.
Feasibility using an Ad-hoc questionnaire
Time frame: From enrollment to the end of treatment at 3 weeks
The ad-hoc questionnaire permitted information about usability, engagement, satisfaction, and pleasure during exposure to the VR environment, as well as feelings and relaxation. The questionnaire is composed of 30 items based on a Likert scale from 1 to 5 (range score from 0 to 4), 15 items based on a Likert scale from 1 to 4 (range score from 0 to 3), and five open-ended questions.
Feasibility using the Non-pharmacological Therapy Experience Scale (NPT-ES)
Time frame: From enrollment to the end of treatment at 3 weeks
The NPT-ES permitted obtaining information about the subjective experience during the administration of non-pharmacological therapy. Five items are assessed on a Likert scale from 0 to 3. The total raw score is from 0 to 15.
Feasibility based on the health staff operator perspective using Focus Groups
Time frame: From enrollment to the end of treatment at 3 weeks
7 secondary outcomes
Assessment of the Responsive Behaviors administering the COHEN MANSFIELD - AGITATION INVENTORY (CMAI)
Time frame: From enrollment to the end of treatment at 3 weeks
Assessment of the Responsive Behaviors administering the Functional Assessment Staging Tool (FAST)
Time frame: From enrollment to the end of treatment at 3 weeks
Investigation of Adverse Symptoms Associated with Exposure to the Virtual Reality Device using the Virtual Reality Symptoms Questionnaire (VRSQ)
Time frame: From enrollment to the end of treatment at 3 weeks
Pain experience assessment using the Pain Assessment in Advanced Dementia (PAINAD)
Time frame: From enrollment to the end of treatment at 3 weeks
Assessment of the pharmacotherapy administration and the users'behaviors before or during the VR sessions using the DataSheet 2
Time frame: From enrollment to the end of treatment at 3 weeks
Assessment of the state-anxiety using the State-Trait Anxiety Inventory-Y1 (STAI-Y1)
Time frame: From enrollment to the end of treatment at 3 weeks
Emotional and behavioral assessment using the Observed Emotion Rating Scale (OERS)
Time frame: From enrollment to the end of treatment at 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 41360455Pardini S, Gios L, Dianti M, Genovese A, Lamon M, Marcon J, Forti S, Mayora-Ibarra O. Exploring customised virtual environments in patients with cognitive decline and responsive behaviours: protocol for a proof-of-concept and feasibility study in a long-term care facility (iEMBRACE). BMJ Open. 2025 Dec 5;15(12):e098051. doi: 10.1136/bmjopen-2024-098051.
- Individual participant dataSharing planned: Undecided
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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.
Lorenzo Gios contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality in people with Cognitive Impairment and Dementia, run by Fondazione Bruno Kessler at 1 site in Italy.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 18 Nov 2024. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanna Pardini (+39 0461314154, spardini@fbk.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility based on the health staff operator perspective using the System Usability Scale (SUS) (time frame: From enrollment to the end of treatment at 3 weeks). The study lists 4 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 NCT06693193, which also lists 1 linked publication.
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 18 Nov 2024.