Cognitive ImpairmentVR-LTCNCT07658287
Immersive Virtual Reality for Older Adults in Long-Term Care Settings
A study testing Adapted Virtual Reality Mindfulness Meditation Program in people with Cognitive Impairment and Long-term Care Centres for Old Adults Users, run by Laval University at 2 sites in Canada.
Trial summary
The goal of this clinical trial is to learn if an immersive virtual reality mindfulness meditation program is feasible and acceptable for older adults living in long-term care settings in Quebec who have mild to moderate neurocognitive disorder. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment, Long-term Care Centres for Old Adults Users
- What is being tested?
- Adapted Virtual Reality Mindfulness Meditation Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- 14 Sep 2026to 15 Jun 2027
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For resident participants:
- Resident of a participating long-term care facility, seniors' home, or alternative seniors' home in the Chaudière-Appalaches or Capitale-Nationale regions of Quebec
- Aged 60 years or older
- Able to understand French or English
- Able to provide informed consent or assent, or have consent provided by a legally authorized representative or person authorized to consent
- Mild to moderate cognitive impairment or neurocognitive disorder
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- Normal or corrected vision and hearing
- For staff participants:
- Regularly works with at least one resident participating in Phase 3
- Has completed the revised virtual reality training provided by Super Splendide and/or Martine Bordeleau
Who cannot join
- For resident participants:
- Recurrent migraines
- Epilepsy
- Traumatic brain injury during the past year
- Glaucoma or recovery from eye surgery
- Diagnosed uncontrolled epilepsy
Show all 11Show fewer
- Diagnosed severe vertigo
- Severe hearing impairment without a corrective hearing device
- Significant visual impairment that would prevent use of a virtual reality headset
- Motion sickness that would prevent use of a virtual reality headset
- Any health condition that restricts movement or prevents safe participation, such as a significant reduction in neck or upper-limb range of motion
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
CIUSSS de la Capitale-Nationale
Québec, Quebec
Line D'Amours (coordinatrice du CEVQ), 4189067465, line.damours.ciussscn@ssss.gouv.qc.ca
- Recruiting
CISSS de Chaudière-Appalaches
Sainte-Marie, Quebec
Louis-Frédéric Lessard (conseiller en milieux de vie), 418-387-8181 ext. 48135, Louis-Frederic.Lessard.cisssca@ssss.gouv.qc.ca
About this study
Official title: Use of Immersive Virtual Reality in Long-Term Care Facilities and Seniors' Homes in Quebec
The goal of this clinical trial is to learn if an immersive virtual reality mindfulness meditation program is feasible and acceptable for older adults living in long-term care settings in Quebec who have mild to moderate neurocognitive disorder. It will also learn about the safety and potential effects of the program on well-being.
The main questions it aims to answer are:
Read more
- Is the virtual reality mindfulness meditation program feasible and acceptable for residents and staff in long-term care settings?
- Does the adapted version of the program show potential benefits for well-being, including depression, anxiety, quality of life, mindfulness, pain, and loneliness?
- What practical challenges, user experiences, and side effects, such as cybersickness, occur during the program?
Researchers will compare the Toujours Dimanche virtual reality mindfulness meditation program designed for older adults with mild to moderate neurocognitive disorder, and standard care alone to see if the adapted program is feasible, acceptable, and potentially helpful.
Participants will:
- Take part in up to 8 virtual reality mindfulness meditation sessions over 4 weeks, if assigned to a virtual reality group
- Complete questionnaires before and after the 4-week study period
- Share feedback about their experience, when possible
- Be observed by staff or research team members to document feasibility, acceptability, user experience, and safety
Read the detailed description
This pilot feasibility trial will evaluate the use of a mindfulness meditation intervention delivered with or without the Toujours Dimanche immersive virtual reality application in long-term care settings in Quebec. The study will be conducted with older adults living in long-term care facilities, seniors' homes, and alternative seniors' homes in the Chaudière-Appalaches and Capitale-Nationale regions who have mild to moderate cognitive impairment or neurocognitive disorder.
The pilot phase will use a randomized experimental design. The purpose of this phase is to evaluate the feasibility, acceptability, safety, user experience, and preliminary effects of the intervention in real-world long-term care settings. This phase will also help identify practical issues related to time management, human resources, data collection, and intervention delivery before a future larger-scale effectiveness trial.
A total of 24 residents will be recruited. This sample size is based on recommendations for feasibility studies, with 12 participants per group. Staff members who regularly work with participating residents and who have completed virtual reality training will also be recruited. These staff members will deliver the intervention and provide feedback on its feasibility and acceptability.
Residents who meet the inclusion and exclusion criteria will be assigned to one of two groups. Group A will receive standard care and the adapted version of the Toujours Dimanche program, which includes guided mindfulness meditation sessions designed for people with cognitive impairment. Group B will receive standard care for four weeks.
Allocation to the groups will be performed using minimization, a method recognized as an acceptable alternative to randomization when the sample size is small. The allocation procedure will consider sex, gender, and age group. The study coordinator will have access to participants' group allocation. The long-term care team will plan the intervention sessions and inform the study coordinator of the selected dates and times.
Participants in Groups A will be invited to complete 8 mindfulness meditation sessions over 4 consecutive weeks, with approximately 2 sessions per week. Each session will last about 5 to 15 minutes, depending on the participant's preferences, comfort, and tolerance. The sessions will be delivered by trained staff members who know the participating residents well. Sessions will take place in the resident's room. Participants may stop a session at any time.
Data will be collected from residents and staff members when possible. If a resident has difficulty communicating verbally or through gestures, the staff member who knows the resident best may provide responses using observer-rated versions of the questionnaires. Sociodemographic information will be collected at baseline. Feedback on the program will be collected after the 4-week study period from residents, when possible, and from staff members.
Feasibility outcomes will include recruitment, adherence, attrition, intervention completion, and practical challenges encountered during implementation. Acceptability will be assessed from the perspectives of residents and staff using researcher-developed questions, including visual analogue scales and open-ended questions. User experience, perceived presence, potential risks, side effects, and other practical issues will also be documented.
Preliminary clinical outcomes will be assessed before the beginning of the intervention and after the end of the 4-week period. The primary clinical outcomes are depression and anxiety. Quality of life will be assessed as a secondary outcome. Mindfulness, pain, and loneliness will be assessed as tertiary or exploratory outcomes. Measures will be administered in a predefined order, beginning with depression and anxiety, followed by quality of life, and then the exploratory outcomes. If a participant shows signs of excessive fatigue or reduced motivation, data collection may be paused or stopped.
Because the study includes residents with cognitive impairment, consent and assent procedures will be adapted to protect residents' rights, comfort, and dignity. When residents are able to provide informed consent, consent will be obtained directly from them. When needed, consent will be obtained from a legal representative or from a person authorized to consent on behalf of the resident. Resident assent will also be sought verbally or behaviorally before participation. Before each visit, residents will be asked whether they are still interested in participating. If a resident refuses, shows distress, or no longer wishes to participate, study activities will stop.
The purpose of this pilot trial is not to determine definitive effectiveness. Rather, it will assess whether the intervention and study procedures are feasible, acceptable, and safe for older adults with mild to moderate cognitive impairment or neurocognitive disorder living in long-term care settings.
- Being tested
- Adapted Virtual Reality Mindfulness Meditation Program, Usual Care
- Keywords
- Virtual Reality, Mindfulness Meditation, Long-Term Care, Older Adults, Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Virtual Reality Mindfulness Meditation ProgramDevice
Immersive Virtual Reality Mindfulness Meditation
Usual CareOther
Standard Care
| Study group | Role | What they receive |
|---|---|---|
| Adapted Toujours Dimanche Virtual Reality Meditation | Experimental | Participants in this group will receive standard care and the adapted Toujours Dimanche immersive virtual reality program. The intervention includes guided mindfulness meditation sessions designed for older adults with mild to moderate cognitive impairment or neurocognitive disorder. Participants will be invited to complete 8 sessions over 4 consecutive weeks, with approximately 2 sessions per week. Each session will last about 5 to 15 minutes. Receives: Device: Adapted Virtual Reality Mindfulness Meditation Program; Other: Usual Care |
| Standard Care | Active comparator | Participants in this group will receive standard care alone for 4 weeks. They will not receive the guided mindfulness meditation intervention or the Toujours Dimanche virtual reality meditation program during the study period. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment, Retention, Adherence, Blinding, and Safety Feasibility Indicators
Feasibility will be assessed descriptively using feasibility indicators recommended by Thabane et al. for pilot studies. These indicators will include recruitment feasibility, assessed by the recruitment rate; intervention completion, assessed through adherence to planned sessions and attrition/retention rates; blinding feasibility, assessed through the effectiveness of blinding procedures; potential risks, assessed through the number, type, frequency, and severity of adverse events; and practical implementation challenges requiring modification of the intervention or study procedures. Reference: Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Medical Research Methodology. 2010;10(1):1-10.
Measured: Up to 4 weeks
Acceptability of the Intervention
Acceptability will be assessed from the perspectives of residents and staff using a researcher-developed acceptability questionnaire designed specifically for this study. The questionnaire includes 1-to-7 visual analogue scales and open-ended questions about the virtual reality mindfulness meditation program. For the 1-to-7 scales, the minimum value is 1 and the maximum value is 7, with higher scores indicating greater acceptability of the intervention. Open-ended responses will be summarized descriptively to document participants' and staff members' perceptions, comments, and suggestions.
Measured: At 4 weeks
Change in Depression Symptoms
Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), completed by the resident when possible and/or by a staff member using an observer-rated version. Total scores range from 0 to 27. Higher scores indicate greater depression symptom severity.
Measured: Baseline and 4 weeks
Change in Anxiety Symptoms
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 item scale (GAD-7), completed by the resident when possible and/or by a staff member using an observer-rated version. Total scores range from 0 to 21. Higher scores indicate greater anxiety symptom severit
Measured: Baseline and 4 weeks
Secondary outcomes (1)
Change in Quality of Life
Quality of life will be assessed using the Quality of Life in Alzheimer's Disease Scale Nursing Home version (QoL-AD-NH), completed by the resident when possible and/or by a caregiver proxy. The QoL-AD-NH includes 13 items assessing key life domains, such as physical health, mood, memory, relationships, and finances. Each item is scored on a 4-point scale: 1 = poor, 2 = fair, 3 = good, and 4 = excellent. Total scores range from 13 to 52, with higher scores indicating better quality of life. Scores from 40 to 52 indicate high quality of life, scores from 27 to 39 indicate moderate quality of life, and scores from 13 to 26 indicate low quality of life.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start14 Sep 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated to one of three parallel groups for a 4-week study period: standard care with the adapted Toujours Dimanche immersive virtual reality mindfulness meditation program, or standard care alone. Participants will remain in their assigned group throughout the study.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Université de Sherbrooke
- Responsible party
- Principal investigator, Martine Bordeleau, Laval University
- Investigators
- Maude Laberge, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658287
- Sponsor's protocol ID
- MP-23-2024-1086
- Acronym
- VR-LTC
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Immersive Virtual Reality in Long-Term Care Facilities and Seniors' Homes in Quebec
- ClinicalTrials.gov ID
- NCT07658287
- Acronym / sponsor ID
- VR-LTC / MP-23-2024-1086
- Keywords
- Virtual Reality, Mindfulness Meditation, Long-Term Care, Older Adults, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- McGill University, Université de Sherbrooke
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 18 Jun 2026 (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 clinical trial is to learn if an immersive virtual reality mindfulness meditation program is feasible and acceptable for older adults living in long-term care settings in Quebec who have mild to moderate neurocognitive disorder. It will also learn about the safety and potential effects of the program on well-being.
The main questions it aims to answer are:
- Is the virtual reality mindfulness meditation program feasible and acceptable for residents and staff in long-term care settings?
- Does the adapted version of the program show potential benefits for well-being, including depression, anxiety, quality of life, mindfulness, pain, and loneliness?
- What practical challenges, user experiences, and side effects, such as cybersickness, occur during the program?
Researchers will compare the Toujours Dimanche virtual reality mindfulness meditation program designed for older adults with mild to moderate neurocognitive disorder, and standard care alone to see if the adapted program is feasible, acceptable, and potentially helpful.
Participants will:
- Take part in up to 8 virtual reality mindfulness meditation sessions over 4 weeks, if assigned to a virtual reality group
- Complete questionnaires before and after the 4-week study period
- Share feedback about their experience, when possible
- Be observed by staff or research team members to document feasibility, acceptability, user experience, and safety
Detailed description
This pilot feasibility trial will evaluate the use of a mindfulness meditation intervention delivered with or without the Toujours Dimanche immersive virtual reality application in long-term care settings in Quebec. The study will be conducted with older adults living in long-term care facilities, seniors' homes, and alternative seniors' homes in the Chaudière-Appalaches and Capitale-Nationale regions who have mild to moderate cognitive impairment or neurocognitive disorder.
The pilot phase will use a randomized experimental design. The purpose of this phase is to evaluate the feasibility, acceptability, safety, user experience, and preliminary effects of the intervention in real-world long-term care settings. This phase will also help identify practical issues related to time management, human resources, data collection, and intervention delivery before a future larger-scale effectiveness trial.
A total of 24 residents will be recruited. This sample size is based on recommendations for feasibility studies, with 12 participants per group. Staff members who regularly work with participating residents and who have completed virtual reality training will also be recruited. These staff members will deliver the intervention and provide feedback on its feasibility and acceptability.
Residents who meet the inclusion and exclusion criteria will be assigned to one of two groups. Group A will receive standard care and the adapted version of the Toujours Dimanche program, which includes guided mindfulness meditation sessions designed for people with cognitive impairment. Group B will receive standard care for four weeks.
Allocation to the groups will be performed using minimization, a method recognized as an acceptable alternative to randomization when the sample size is small. The allocation procedure will consider sex, gender, and age group. The study coordinator will have access to participants' group allocation. The long-term care team will plan the intervention sessions and inform the study coordinator of the selected dates and times.
Participants in Groups A will be invited to complete 8 mindfulness meditation sessions over 4 consecutive weeks, with approximately 2 sessions per week. Each session will last about 5 to 15 minutes, depending on the participant's preferences, comfort, and tolerance. The sessions will be delivered by trained staff members who know the participating residents well. Sessions will take place in the resident's room. Participants may stop a session at any time.
Data will be collected from residents and staff members when possible. If a resident has difficulty communicating verbally or through gestures, the staff member who knows the resident best may provide responses using observer-rated versions of the questionnaires. Sociodemographic information will be collected at baseline. Feedback on the program will be collected after the 4-week study period from residents, when possible, and from staff members.
Feasibility outcomes will include recruitment, adherence, attrition, intervention completion, and practical challenges encountered during implementation. Acceptability will be assessed from the perspectives of residents and staff using researcher-developed questions, including visual analogue scales and open-ended questions. User experience, perceived presence, potential risks, side effects, and other practical issues will also be documented.
Preliminary clinical outcomes will be assessed before the beginning of the intervention and after the end of the 4-week period. The primary clinical outcomes are depression and anxiety. Quality of life will be assessed as a secondary outcome. Mindfulness, pain, and loneliness will be assessed as tertiary or exploratory outcomes. Measures will be administered in a predefined order, beginning with depression and anxiety, followed by quality of life, and then the exploratory outcomes. If a participant shows signs of excessive fatigue or reduced motivation, data collection may be paused or stopped.
Because the study includes residents with cognitive impairment, consent and assent procedures will be adapted to protect residents' rights, comfort, and dignity. When residents are able to provide informed consent, consent will be obtained directly from them. When needed, consent will be obtained from a legal representative or from a person authorized to consent on behalf of the resident. Resident assent will also be sought verbally or behaviorally before participation. Before each visit, residents will be asked whether they are still interested in participating. If a resident refuses, shows distress, or no longer wishes to participate, study activities will stop.
The purpose of this pilot trial is not to determine definitive effectiveness. Rather, it will assess whether the intervention and study procedures are feasible, acceptable, and safe for older adults with mild to moderate cognitive impairment or neurocognitive disorder living in long-term care settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be allocated to one of three parallel groups for a 4-week study period: standard care with the adapted Toujours Dimanche immersive virtual reality mindfulness meditation program, or standard care alone. Participants will remain in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Adapted Toujours Dimanche Virtual Reality Meditation | Experimental | Device: Adapted Virtual Reality Mindfulness Meditation Program, Other: Usual CareParticipants in this group will receive standard care and the adapted Toujours Dimanche immersive virtual reality program. The intervention includes guided mindfulness meditation sessions designed for older adults with mild to moderate cognitive impairment or neurocognitive disorder. Participants will be invited to complete 8 sessions over 4 consecutive weeks, with approximately 2 sessions per week. Each session will last about 5 to 15 minutes. |
| Standard Care | Active comparator | Other: Usual CareParticipants in this group will receive standard care alone for 4 weeks. They will not receive the guided mindfulness meditation intervention or the Toujours Dimanche virtual reality meditation program during the study period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Resident of a participating long-term care facility, seniors' home, or alternative seniors' home in the Chaudière-Appalaches or Capitale-Nationale regions of Quebec
- Aged 60 years or older
- Able to understand French or English
- Able to provide informed consent or assent, or have consent provided by a legally authorized representative or person authorized to consent
- Mild to moderate cognitive impairment or neurocognitive disorder
Key exclusion criteria (11 listed)
- Recurrent migraines
- Epilepsy
- Traumatic brain injury during the past year
- Glaucoma or recovery from eye surgery
- Diagnosed uncontrolled 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 |
|---|---|---|
| Adapted Virtual Reality Mindfulness Meditation ProgramImmersive Virtual Reality Mindfulness Meditation | Device | Adapted Toujours Dimanche Virtual Reality Meditation |
| Usual CareStandard Care | Other | Adapted Toujours Dimanche Virtual Reality Meditation, Standard Care |
Primary outcome
Recruitment, Retention, Adherence, Blinding, and Safety Feasibility Indicators
Time frame: Up to 4 weeks
Feasibility will be assessed descriptively using feasibility indicators recommended by Thabane et al. for pilot studies. These indicators will include recruitment feasibility, assessed by the recruitment rate; intervention completion, assessed through adherence to planned sessions and attrition/retention rates; blinding feasibility, assessed through the effectiveness of blinding procedures; potential risks, assessed through the number, type, frequency, and severity of adverse events; and practical implementation challenges requiring modification of the intervention or study procedures. Reference: Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Medical Research Methodology. 2010;10(1):1-10.
Acceptability of the Intervention
Time frame: At 4 weeks
Acceptability will be assessed from the perspectives of residents and staff using a researcher-developed acceptability questionnaire designed specifically for this study. The questionnaire includes 1-to-7 visual analogue scales and open-ended questions about the virtual reality mindfulness meditation program. For the 1-to-7 scales, the minimum value is 1 and the maximum value is 7, with higher scores indicating greater acceptability of the intervention. Open-ended responses will be summarized descriptively to document participants' and staff members' perceptions, comments, and suggestions.
Change in Depression Symptoms
Time frame: Baseline and 4 weeks
Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), completed by the resident when possible and/or by a staff member using an observer-rated version. Total scores range from 0 to 27. Higher scores indicate greater depression symptom severity.
Change in Anxiety Symptoms
Time frame: Baseline and 4 weeks
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 item scale (GAD-7), completed by the resident when possible and/or by a staff member using an observer-rated version. Total scores range from 0 to 21. Higher scores indicate greater anxiety symptom severit
1 secondary outcome
Change in Quality of Life
Time frame: Baseline and 4 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 10 Sep 2026.
- 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.
Maude Laberge, PhD principal investigator
Laval University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Virtual Reality Mindfulness Meditation Program in people with Cognitive Impairment and Long-term Care Centres for Old Adults Users, run by Laval University at 2 sites in Canada.
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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 Martine Bordeleau, PhD (581-490-2626, martine.bordeleau@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment, Retention, Adherence, Blinding, and Safety Feasibility Indicators (time frame: Up to 4 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?
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 10 Sep 2026.