An interventional study of Adapted Virtual Reality Mindfulness Meditation Program and Usual Care in Cognitive Impairment and Long-term Care Centres for Old Adults Users, sponsored by Laval University. Recruiting at 2 sites in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Laval University · Not applicable, Interventional, and Supportive care
Among 223 studies in Cognitive Dysfunction with a site in Canada — 60 open to participants now, 79 under way, 7 of them phase 3. Cognitive Dysfunction · Canada.
Among the 223 studies in Cognitive Dysfunction with a site in Canada, this one is the 135th largest by planned enrollment of the 170 interventional ones that give a count, is one of 10 that started in 2026, is one of 115 with no phase, reaches primary completion later than 49 of the 78 other live ones, and was the 219th registered.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
Browse Cognitive Dysfunction studies →60 of the 223 studies in Cognitive Dysfunction with a site in Canada are open now. Recruiting first, the newest first:
Posit Science Corporation · Sites in Canada
Qanatpharma AG · Sites in Canada
University of British Columbia · Sites in Canada
Ottawa Hospital Research Institute · Sites in Canada
Western University, Canada · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
223 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 29 · Phase 3 21 · Phase 4 3
First in 1999; this study’s year is marked. 10 started in 2026.
This study's planned enrollment of 24 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Median enrollment 62 across the 170 interventional studies, 353 across the 52 observational. Of the 121 that completed or were terminated, 17 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
38 of 223 have an industry lead sponsor. The 10 most frequent:
Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.
Laval University has 3 studies filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
24 of the studies in Cognitive Dysfunction with a site in Canada that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT05230758Phase 3Donald MabbottEffect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour | 2027-11-30 |
| NCT06529744University Health Network, TorontoImproving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling | 2026-11 |
| NCT04335994Sunnybrook Health Sciences CentreENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing | 2026-12 |
| NCT06783283Centre for Addiction and Mental HealthTACS to Engage Theta-Gamma Coupling and Enhance Working Memory in Patients With MCI (tACS-MCI) | 2026-12 |
Among the 223 studies in Cognitive Dysfunction with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For resident participants:
For staff participants:
Exclusion Criteria:
For resident participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Adapted Virtual Reality Mindfulness Meditation Program · Other: Usual Care
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.
Other: Usual Care
Immersive Virtual Reality Mindfulness Meditation
Standard Care
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline and 4 weeks
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.
Time frame: Baseline and 4 weeks
Change in Self-Reported Pain Intensity
Self-reported pain intensity will be assessed using the Numeric Rating Scale (NRS), completed by the resident when possible. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
Time frame: Baseline and 4 weeks
Change in Observed Pain
Observed pain will be assessed using the Pain Assessment in Advanced Dementia Scale (PAIN-AD), completed by a staff member. The PAIN-AD includes 5 observed behavioral indicators, each scored from 0 to 2. Total scores range from 0 to 10, with higher scores indicating more pain-related behaviors. A score of 0 indicates no observed pain-related behavior; scores from 1 to 3 may indicate mild pain; scores from 4 to 6 may indicate moderate pain; and scores from 7 to 10 may indicate severe pain.
Time frame: Baseline and 4 weeks
Change in Loneliness
Loneliness will be assessed using the UCLA Loneliness Scale short form (ULS-6), completed by the resident when possible. The ULS-6 includes 6 items. Total scores range from 6 to 24, with higher scores indicating greater loneliness.
Time frame: Baseline and 4 weeks
Change in Social Engagement
Social engagement will be assessed using the Engagement of a Person with Dementia Scale (EPWDS), completed by a staff member. The EPWDS includes 10 items assessing affective, visual, verbal, behavioral, and social engagement. Each item is scored on a 1-to-5 scale, with some items reverse scored. Total scores range from 10 to 50. Higher scores indicate greater positive engagement, while lower scores indicate greater disengagement or negative engagement.
Time frame: Baseline and 4 weeks
Change in Daily Mindful Responding
Daily mindful responding will be assessed using the Daily Mindful Responding Scale (DMRS), completed by the resident when possible. The DMRS is a 4-item scale designed to assess mindful responding in daily life. Items are rated on a 1-to-10 scale, and item scores are averaged to compute the total score. Total scores range from 1 to 10. Higher scores indicate greater mindful responding in daily life.
Time frame: Baseline and 4 weeks
Change in Observed Mindfulness
Observed mindfulness will be assessed using the Observed Mindfulness Measure (OMM), completed by a staff member who knows the resident. The OMM is a 9-item observer-rated questionnaire assessing mindful behaviors, including awareness, acceptance, and attentiveness. Total scores range from 9 to 45. Higher scores indicate greater observed mindful behavior.
Time frame: Baseline and 4 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 9 months is below that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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