DementiaNCT07431164
Augmented Reality-Based Aromatherapy Education for Older Adults With Early-Stage Dementia in Taiwan
A study testing Augmented Reality-Based Aromatherapy Education Program in people with Dementia and Mild Cognitive Impairment (MCI), run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
This study evaluates an augmented reality (AR)-based aromatherapy education program designed for older adults with early-stage dementia in Taiwan. Participants are randomly assigned to either the intervention group, which receives AR-supported aromatherapy education sessions, or a comparison group receiving standard… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Mild Cognitive Impairment (MCI), Neuropsychiatric Symptoms
- What is being tested?
- Augmented Reality-Based Aromatherapy Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 May 2025to Mar 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- AD-8 score ≥ 2, indicating suspected cognitive impairment
- Ability to communicate and complete study questionnaires
- No significant visual, hearing, or olfactory impairments
- Willingness to participate in AR-based intervention sessions
Who cannot join
- Diagnosed psychiatric disorder
- Complex chronic physical diseases
- Moderate to severe dementia
- Neuropsychiatric Inventory Questionnaire (NPI-Q) symptom score > 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Augmented Reality-Based Aromatherapy Education on Symptoms in Older Adults With Early-Stage Dementia in Taiwan
This study evaluates an augmented reality (AR)-based aromatherapy education program designed for older adults with early-stage dementia in Taiwan. Participants are randomly assigned to either the intervention group, which receives AR-supported aromatherapy education sessions, or a comparison group receiving standard activities. The primary objective is to assess changes in neuropsychiatric symptoms and psychological well-being. Secondary outcomes include cognitive function and quality of life. The study aims to explore the feasibility and potential clinical benefits of integrating digital technology with non-pharmacological dementia care approaches.
Read the detailed description
The study includes multiple phases designed to examine both immediate and longer-term effects of the intervention.
Phase 1 - Structured AR-Based Aromatherapy Education (Weeks 1-4):
Participants receive the AR-based aromatherapy education program consisting of 12 structured sessions delivered over four weeks. Sessions integrate AR-guided instruction with hands-on aromatherapy learning activities.
The Augmented Reality (AR)-Based Aromatherapy Education Module was systematically developed according to the 12 symptom domains of the Neuropsychiatric Inventory Questionnaire (NPI-Q). Each unit was designed to align a specific neuropsychiatric symptom with targeted plant-based aromatic stimulation, structured educational activities, and symptom-oriented behavioral goals. The intervention consisted of 12 structured units delivered over four to six consecutive weeks (two to three sessions per week). Each session integrated AR-based digital guidance with hands-on aromatherapy activities to provide multisensory stimulation, cognitive engagement, and structured emotional regulation support.
Phase 2 - Aromatherapy Withdrawal Observation (Weeks 5-8):
Following completion of the structured sessions, aromatherapy products are discontinued to observe potential maintenance or withdrawal effects of the intervention. Participants continue routine daily activities without additional aromatherapy sessions.
Phase 3 - Personalized Aromatherapy Support (Weeks 9-12):
Based on symptom profiles and individual preferences, participants may receive guidance on the use of personalized aromatherapy products intended to support symptom management in daily life.
Phase 4 - Follow-Up Observation (Weeks 13-16):
Participants are followed to evaluate the sustainability of intervention effects. Outcome assessments are conducted to examine longer-term changes in neuropsychiatric symptoms and related health outcomes.
The comparison group receives routine care and standard daily activities at the care setting without participation in the AR-based aromatherapy education program.
- Being tested
- Augmented Reality-Based Aromatherapy Education Program
- Keywords
- Augmented Reality, digital health, dementia, aromatherapy, health education
- Medical subject headings
- Dementia, Cognitive Dysfunction, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality-Based Aromatherapy Education ProgramBehavioural
The augmented reality-based aromatherapy education module was developed using the Neuropsychiatric Symptom Checklist-Q (NPI-Q) framework to match specific neuropsychiatric symptoms with corresponding aromatherapy interventions. This intervention program was designed and refined by a multidisciplinary team of experts. The course comprises 12 units, completed over four consecutive weeks through 2-3 units per week. To ensure a systematic approach, each session integrates three units, allowing for comprehensive coverage of symptom clusters within a structured timeframe. Each symptom corresponds to a specific aromatherapy activity and its associated learning objectives.
| Study group | Role | What they receive |
|---|---|---|
| AR-Based Aromatherapy Education Group | Experimental | Participants receive a structured augmented reality (AR)-based aromatherapy education program designed to reduce neuropsychiatric symptoms and enhance psychological well-being in older adults with early-stage dementia. The intervention includes guided AR modules integrating sensory stimulation, aromatherapy education, and interactive cognitive engagement over the study period. Receives: Behavioral: Augmented Reality-Based Aromatherapy Education Program |
| Standard Care Control Group | No intervention | Participants receive routine care without AR-based aromatherapy intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neuropsychiatric Symptoms Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)
Neuropsychiatric symptoms are assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q), an informant-based instrument evaluating behavioral and psychological symptoms over the past month. Each symptom is rated for severity on a 3-point scale (1 = mild, 2 = moderate, 3 = severe). Total scores range from 0 to 36, with higher scores indicating more severe neuropsychiatric symptoms (worse outcome). Changes in total scores from baseline will be analyzed.
Measured: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Secondary outcomes (4)
Pain (Abbey Pain Scale)
Pain is assessed using the Abbey Pain Scale, an observational tool designed to evaluate pain in individuals who may have difficulty verbally communicating discomfort. The scale consists of six behavioral indicators (vocalization, facial expression, change in body language, behavioral change, physiological change, and physical changes), each rated on a 4-point scale (0 = absent to 3 = severe). The total score ranges from 0 to 18, with higher scores indicating greater pain severity (worse outcome). Changes in total scores from baseline will be analyzed.
Measured: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Insomnia (Athens Insomnia Scale)
Insomnia symptoms are assessed using the Athens Insomnia Scale (AIS), a self-report instrument designed to evaluate sleep difficulties based on the diagnostic criteria of insomnia. The scale consists of eight items assessing sleep induction, awakenings during the night, early morning awakening, total sleep duration, sleep quality, well-being during the day, functioning capacity, and sleepiness during the day. Each item is rated on a 4-point scale (0-3). The total score ranges from 0 to 24, with higher scores indicating more severe insomnia symptoms (worse outcome). Changes in total scores from baseline will be analyzed.
Measured: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Well-Being (WHO-5)
Psychological well-being is assessed using the World Health Organization-Five Well-Being Index (WHO-5), a self-report questionnaire measuring positive mood, vitality, and general interest in daily activities over the previous two weeks. The scale includes five items, each rated on a 6-point scale (0-5). The total score ranges from 0 to 25, with higher scores indicating better psychological well-being (better outcome). Changes in total scores from baseline will be analyzed.
Measured: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Life Satisfaction (SWLS)
Life satisfaction is assessed using the Satisfaction With Life Scale (SWLS), a self-report instrument measuring global cognitive judgments of one's life satisfaction. The scale consists of five items, each rated on a 7-point Likert scale (1-7) ranging from strongly disagree to strongly agree. The total score ranges from 5 to 35, with higher scores indicating greater life satisfaction (better outcome). Changes in total scores from baseline will be analyzed.
Measured: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start23 May 2025
- Primary completion30 Oct 2025
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the AR-based aromatherapy education intervention group or a comparison group receiving standard activities. Both groups are followed concurrently over the same study period.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong-Long Guo, PhD, Study chair, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431164
- Sponsor's protocol ID
- NTNU-AR-Aroma-2025
- Other IDs
- NSTC 112-2410-H-003-061-MY2
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in this trial will be made available upon reasonable request after publication. Access requires a formal request to the corresponding author and approval. Data will be shared in accordance with institutional review board approval and applicable data protection regulations. Researchers requesting access must provide a methodologically sound proposal and sign a data use agreement. Only de-identified data will be shared; no direct identifiers will be released.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Augmented Reality-Based Aromatherapy Education on Symptoms in Older Adults With Early-Stage Dementia in Taiwan
- ClinicalTrials.gov ID
- NCT07431164
- Acronym / sponsor ID
- NTNU-AR-Aroma-2025
- Keywords
- Augmented Reality, digital health, dementia, aromatherapy, health education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- Mar 2026 (estimated)
- First posted
- 24 Feb 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.
This study evaluates an augmented reality (AR)-based aromatherapy education program designed for older adults with early-stage dementia in Taiwan. Participants are randomly assigned to either the intervention group, which receives AR-supported aromatherapy education sessions, or a comparison group receiving standard activities. The primary objective is to assess changes in neuropsychiatric symptoms and psychological well-being. Secondary outcomes include cognitive function and quality of life. The study aims to explore the feasibility and potential clinical benefits of integrating digital technology with non-pharmacological dementia care approaches.
Detailed description
The study includes multiple phases designed to examine both immediate and longer-term effects of the intervention.
Phase 1 - Structured AR-Based Aromatherapy Education (Weeks 1-4):
Participants receive the AR-based aromatherapy education program consisting of 12 structured sessions delivered over four weeks. Sessions integrate AR-guided instruction with hands-on aromatherapy learning activities.
The Augmented Reality (AR)-Based Aromatherapy Education Module was systematically developed according to the 12 symptom domains of the Neuropsychiatric Inventory Questionnaire (NPI-Q). Each unit was designed to align a specific neuropsychiatric symptom with targeted plant-based aromatic stimulation, structured educational activities, and symptom-oriented behavioral goals. The intervention consisted of 12 structured units delivered over four to six consecutive weeks (two to three sessions per week). Each session integrated AR-based digital guidance with hands-on aromatherapy activities to provide multisensory stimulation, cognitive engagement, and structured emotional regulation support.
Phase 2 - Aromatherapy Withdrawal Observation (Weeks 5-8):
Following completion of the structured sessions, aromatherapy products are discontinued to observe potential maintenance or withdrawal effects of the intervention. Participants continue routine daily activities without additional aromatherapy sessions.
Phase 3 - Personalized Aromatherapy Support (Weeks 9-12):
Based on symptom profiles and individual preferences, participants may receive guidance on the use of personalized aromatherapy products intended to support symptom management in daily life.
Phase 4 - Follow-Up Observation (Weeks 13-16):
Participants are followed to evaluate the sustainability of intervention effects. Outcome assessments are conducted to examine longer-term changes in neuropsychiatric symptoms and related health outcomes.
The comparison group receives routine care and standard daily activities at the care setting without participation in the AR-based aromatherapy education program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the AR-based aromatherapy education intervention group or a comparison group receiving standard activities. Both groups are followed concurrently over the same study period.
| Arm | Type | Receives |
|---|---|---|
| AR-Based Aromatherapy Education Group | Experimental | Behavioral: Augmented Reality-Based Aromatherapy Education ProgramParticipants receive a structured augmented reality (AR)-based aromatherapy education program designed to reduce neuropsychiatric symptoms and enhance psychological well-being in older adults with early-stage dementia. The intervention includes guided AR modules integrating sensory stimulation, aromatherapy education, and interactive cognitive engagement over the study period. |
| Standard Care Control Group | No intervention | –Participants receive routine care without AR-based aromatherapy intervention during the study period. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65 years
- AD-8 score ≥ 2, indicating suspected cognitive impairment
- Ability to communicate and complete study questionnaires
- No significant visual, hearing, or olfactory impairments
- Willingness to participate in AR-based intervention sessions
Key exclusion criteria (4 listed)
- Diagnosed psychiatric disorder
- Complex chronic physical diseases
- Moderate to severe dementia
- Neuropsychiatric Inventory Questionnaire (NPI-Q) symptom score > 3
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 |
|---|---|---|
| Augmented Reality-Based Aromatherapy Education ProgramThe augmented reality-based aromatherapy education module was developed using the Neuropsychiatric Symptom Checklist-Q (NPI-Q) framework to match specific neuropsychiatric symptoms with corresponding aromatherapy interventions. This intervention program was designed and refined by a multidisciplinary team of experts. The course comprises 12 units, completed over four consecutive weeks through 2-3 units per week. To ensure a systematic approach, each session integrates three units, allowing for comprehensive coverage of symptom clusters within a structured timeframe. Each symptom corresponds to a specific aromatherapy activity and its associated learning objectives. | Behavioural | AR-Based Aromatherapy Education Group |
Primary outcome
Change in Neuropsychiatric Symptoms Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Neuropsychiatric symptoms are assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q), an informant-based instrument evaluating behavioral and psychological symptoms over the past month. Each symptom is rated for severity on a 3-point scale (1 = mild, 2 = moderate, 3 = severe). Total scores range from 0 to 36, with higher scores indicating more severe neuropsychiatric symptoms (worse outcome). Changes in total scores from baseline will be analyzed.
4 secondary outcomes
Pain (Abbey Pain Scale)
Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Insomnia (Athens Insomnia Scale)
Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Well-Being (WHO-5)
Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Life Satisfaction (SWLS)
Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
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 9 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in this trial will be made available upon reasonable request after publication. Access requires a formal request to the corresponding author and approval. Data will be shared in accordance with institutional review board approval and applicable data protection regulations. Researchers requesting access must provide a methodologically sound proposal and sign a data use agreement. Only de-identified data will be shared; no direct identifiers will be released.
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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.
Jong-Long Guo, PhD study chair
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality-Based Aromatherapy Education Program in people with Dementia and Mild Cognitive Impairment (MCI), run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. 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 Taiwan. 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?
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?
Change in Neuropsychiatric Symptoms Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) (time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)). 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 9 Mar 2026.