Mild Cognitive ImpairmentSENSENCT07234357
Sensory Enrichment Using Aromatherapy for Neurobehavioral and Psychological Symptoms in Early Dementia
A study testing Aromatherapy in people with Mild Cognitive Impairment and Mild Dementia, run by National Cancer Centre, Singapore at 2 sites in Singapore.
Trial summary
To determine if diffusion aromatherapy exposure to an essential oil blend can potentially improve mild cognitive impairment/mild dementia symptoms and relieve caregiver stress. This study also allows us to gauge the willingness of elderly patients in complying with long-term aromatherapy treatments. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSingapore
- Study dates
- 9 Jun 2026to Nov 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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For patients:
- Aged 50 years old and above.
- Confirmed diagnosis of MCI or mild dementia based on clinical records.
- Has one identified caregiver aged 21 years and above who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study intervention.
- For caregivers:
- Aged 21 years old and above.
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- Willing and able to provide written informed consent
- Identified as the caregiver for recruited patient in this study can read, understand, and speak the designated language at the study site; either lives with the recruited patients or sees the patient for ≥2 hours/day ≥3 days/week.
- Agrees to accompany the patient to each study visit; and can verify daily compliance with study intervention.
Who cannot join
- For patients:
- Olfactory impaired/dysfunctional.
- Known or suspected hypersensitivity/allergy to essential oils or any components of the formulations.
- Has Reactive Airway Disease (e.g, Asthma).
- Participant without a caregiver.
- Pregnant, breastfeeding, or intending to conceive during study period.
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- For caregivers:
- Physically or mentally incapable of providing verbal / written consent
- Does not have regular or meaningful contact with the participant (e.g. less than 2 hours/day or less than 3 days/week).
- Not able to follow patient to each study visit.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dr Laura BG Tay, MBBS, MMed, MRCP, MCI contact
Singapore2 sites, 2 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Prof Teh Bin Tean, MBBS, PhD
- Recruiting
Sengkang General Hospital
Singapore, 544886
Dr Laura BG Tay, MBBS, MMed, MRCP, MCI
About this study
Official title: Sensory Enrichment Using Aromatherapy for Neurobehavioral and Psychological Symptoms in Early Dementia (SENSE)
To determine if diffusion aromatherapy exposure to an essential oil blend can potentially improve mild cognitive impairment/mild dementia symptoms and relieve caregiver stress.
This study also allows us to gauge the willingness of elderly patients in complying with long-term aromatherapy treatments.
Read the detailed description
SENSE is a non-blinded study that aims to recruit 200 participants, consisting of 200 patients with MCI or mild dementia, along with their respective caregivers. Participants will be recruited from the Geriatric Clinic and Psychology Clinic in Sengkang General Hospital, in either English or Chinese. Participants are randomized into the control and intervention group, in which the latter will receive an aromatherapy diffuser, a proprietary aromatic asian plant extract (AAPE) as an essential oil blend to add into the diffuser, and an aromatherapy diary to fill up for 6 months. The participants of the intervention group are to diffuse the essential oils twice daily for a minimum of 5 minutes each session, and will also receive phone calls at the 2, 4, 6, 8, 16, and 20th week timepoint to check on compliance and adverse events.
Both the control and intervention group will complete questionnaires on the first visit, mid-intervention visit (12th week timepoint) and final visit (24th week timepoint):
Patients:
- Patient Baseline Data Collection Form (only for first visit)
- Singapore Version of Montreal Cognitive Assessment (MoCA)
- Cornell Scale for Depression in Dementia (CSDD)
- Rating Anxiety in Dementia (RAID)
- Sniffin' Sticks Olfactory Test (only for first and final visit)
Caregivers:
- Caregiver Baseline Data Collection Form (CBDCF)
- Neuropsychiatric Inventory Questionnaire (NPI-Q)
- ZBI-12 (Zarit Caregiver Burden Assessment)
All three visits are physical visits at Sengkang General Hospital. Upon completion of each physical visit's requirements, participants will receive a $10 reimbursement voucher.
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Being tested
- No Intervention, Aromatherapy
- Keywords
- Aromatherapy, Diffusion Aromatherapy, Essential Oils, Mild Cognitive Impairment (MCI), Mild Dementia, Dementia, Caregiver Burden, Caregiver Stress, Elderly Compliance, Caregiver
- Medical subject headings
- Cognitive Dysfunction, Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Participants randomised to the control group will only complete the behavioural and caregiver assessments.
AromatherapyOther
Besides being given assessments mentioned in the control group, participants randomised to the intervention group will be provided with a diffuser, the first batch of the AAPE oil blend (patient to choose 1 out of the 2 blends), and detailed instructions on aromatherapy use. They will be instructed to diffuse 1-2 drops of the oil for 30 minutes in the morning and before bedtime (minimally 5 minutes), inhaling and relaxing during these sessions. An Aromatherapy Diary will be provided to track daily compliance, record adverse events, and document the number of minutes used each night.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Not described Receives: Other: No Intervention |
| Intervention Group | Experimental | Not described Receives: Other: Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of an olfactory enrichment program in improving the well-being of patients with mild cognitive impairment (MCI) and dementia.
To gauge the compliance and willingness to comply with long-term aromatherapy treatments in their homes, in a local context.
Compliance rate will be calculated using the total number of sessions that the participants have fulfilled, for at least 5 minutes each session.
Patients that are unable to meet the minimum of 50% compliance will be withdrawn from the study.
Measured: Mid-intervention (12 weeks), and post intervention (24 weeks).
Preliminary efficacy of the intervention in reducing Behavioural and Psychological Symptoms of Dementia (BPSD) to inform sample size calculations for a larger study through the use of Rating Anxiety in Dementia (RAID) Questionnaire.
RAID utilizes a scale that includes "unable to evaluate" and 0-3. Questionnaires are analysed by tabulating the total scores of each questionnaire to assess the severity of anxiety.
Measured: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
Preliminary efficacy of the intervention in reducing Behavioural and Psychological Symptoms of Dementia (BPSD) to inform sample size calculations for a larger study through the use of Cornell Scale for Depression in Dementia (CSDD) Questionnaire.
CSDD utilizes a scale that includes "absent" and 0-2. Questionnaires are analysed by tabulating the total scores of each questionnaire to assess the severity of depressive symptoms.
Measured: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
Secondary outcomes (3)
Preliminary efficacy of the intervention in maintaining cognitive function in patients with MCI and dementia.
This is measured using the Montreal Cognitive Assessment (MoCA), which measures cognitive function on a 30-point scale. A higher score indicates better cognitive function.
Measured: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
Impact of the intervention on caregiver stress and burden via Neuropsychiatric Inventory Questionnaire (NPI-Q)
For the caregivers to fill, to see if the impact of diffusion aromatherapy on the respective patients can improve behavioural symptoms observed in the patient. The NPI-Q requires rating presence of a symptom (a "yes" or "no" screening question), the severity on a 1-3 point scale, and caregiver's distress from the symptom on a 0-5 point scale. The total scores of these questionnaires help to assess the severity of caregiver stress and burden, with a higher total score suggesting overall a greater presence of neuropsychiatric symptoms.
Measured: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
Impact of the intervention on caregiver stress and burden via ZBI-12 (Zarit Caregiver Burden Assessment)
For the caregivers to fill, to see if the impact of diffusion aromatherapy on the respective patients can potentially relieve some caregiver stress and burden. The ZBI-12 is completed by the caregivers and utilises a 0-4 point scoring system for 12 questions totaling a score from 0 to 48, where higher scores indicate greater caregiver burden.
Measured: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 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 2025
- Study start9 Jun 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild 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
- Only the intervention group will receive the aromatherapy diffusion, while the control group will not.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Temasek Foundation
- Responsible party
- Sponsor
- Investigators
- Prof Teh Bin Tean, MBBS, PhD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234357
- Sponsor's protocol ID
- 2025/0299
- Acronym
- SENSE
- Status last verified
- Jul 2026
- First submitted
- 14 Nov 2025
- Last updated
- 17 Jul 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Enrichment Using Aromatherapy for Neurobehavioral and Psychological Symptoms in Early Dementia (SENSE)
- ClinicalTrials.gov ID
- NCT07234357
- Acronym / sponsor ID
- SENSE / 2025/0299
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Keywords
- Aromatherapy, Diffusion Aromatherapy, Essential Oils, Mild Cognitive Impairment (MCI), Mild Dementia, Dementia, Caregiver Burden, Caregiver Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Temasek Foundation
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Nov 2025 (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.
To determine if diffusion aromatherapy exposure to an essential oil blend can potentially improve mild cognitive impairment/mild dementia symptoms and relieve caregiver stress.
This study also allows us to gauge the willingness of elderly patients in complying with long-term aromatherapy treatments.
Detailed description
SENSE is a non-blinded study that aims to recruit 200 participants, consisting of 200 patients with MCI or mild dementia, along with their respective caregivers. Participants will be recruited from the Geriatric Clinic and Psychology Clinic in Sengkang General Hospital, in either English or Chinese. Participants are randomized into the control and intervention group, in which the latter will receive an aromatherapy diffuser, a proprietary aromatic asian plant extract (AAPE) as an essential oil blend to add into the diffuser, and an aromatherapy diary to fill up for 6 months. The participants of the intervention group are to diffuse the essential oils twice daily for a minimum of 5 minutes each session, and will also receive phone calls at the 2, 4, 6, 8, 16, and 20th week timepoint to check on compliance and adverse events.
Both the control and intervention group will complete questionnaires on the first visit, mid-intervention visit (12th week timepoint) and final visit (24th week timepoint):
Patients:
- Patient Baseline Data Collection Form (only for first visit)
- Singapore Version of Montreal Cognitive Assessment (MoCA)
- Cornell Scale for Depression in Dementia (CSDD)
- Rating Anxiety in Dementia (RAID)
- Sniffin' Sticks Olfactory Test (only for first and final visit)
Caregivers:
- Caregiver Baseline Data Collection Form (CBDCF)
- Neuropsychiatric Inventory Questionnaire (NPI-Q)
- ZBI-12 (Zarit Caregiver Burden Assessment)
All three visits are physical visits at Sengkang General Hospital. Upon completion of each physical visit's requirements, participants will receive a $10 reimbursement voucher.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Only the intervention group will receive the aromatherapy diffusion, while the control group will not.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: No Intervention |
| Intervention Group | Experimental | Other: Aromatherapy |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 50 years old and above.
- Confirmed diagnosis of MCI or mild dementia based on clinical records.
- Has one identified caregiver aged 21 years and above who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study intervention.
- Aged 21 years old and above.
- Willing and able to provide written informed consent
Key exclusion criteria (10 listed)
- Olfactory impaired/dysfunctional.
- Known or suspected hypersensitivity/allergy to essential oils or any components of the formulations.
- Has Reactive Airway Disease (e.g, Asthma).
- Participant without a caregiver.
- Pregnant, breastfeeding, or intending to conceive during study period.
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 |
|---|---|---|
| No InterventionParticipants randomised to the control group will only complete the behavioural and caregiver assessments. | Other | Control Group |
| AromatherapyBesides being given assessments mentioned in the control group, participants randomised to the intervention group will be provided with a diffuser, the first batch of the AAPE oil blend (patient to choose 1 out of the 2 blends), and detailed instructions on aromatherapy use. They will be instructed to diffuse 1-2 drops of the oil for 30 minutes in the morning and before bedtime (minimally 5 minutes), inhaling and relaxing during these sessions. An Aromatherapy Diary will be provided to track daily compliance, record adverse events, and document the number of minutes used each night. | Other | Intervention Group |
Primary outcome
Feasibility and acceptability of an olfactory enrichment program in improving the well-being of patients with mild cognitive impairment (MCI) and dementia.
Time frame: Mid-intervention (12 weeks), and post intervention (24 weeks).
To gauge the compliance and willingness to comply with long-term aromatherapy treatments in their homes, in a local context. Compliance rate will be calculated using the total number of sessions that the participants have fulfilled, for at least 5 minutes each session. Patients that are unable to meet the minimum of 50% compliance will be withdrawn from the study.
Preliminary efficacy of the intervention in reducing Behavioural and Psychological Symptoms of Dementia (BPSD) to inform sample size calculations for a larger study through the use of Rating Anxiety in Dementia (RAID) Questionnaire.
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
RAID utilizes a scale that includes "unable to evaluate" and 0-3. Questionnaires are analysed by tabulating the total scores of each questionnaire to assess the severity of anxiety.
Preliminary efficacy of the intervention in reducing Behavioural and Psychological Symptoms of Dementia (BPSD) to inform sample size calculations for a larger study through the use of Cornell Scale for Depression in Dementia (CSDD) Questionnaire.
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
CSDD utilizes a scale that includes "absent" and 0-2. Questionnaires are analysed by tabulating the total scores of each questionnaire to assess the severity of depressive symptoms.
3 secondary outcomes
Preliminary efficacy of the intervention in maintaining cognitive function in patients with MCI and dementia.
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
Impact of the intervention on caregiver stress and burden via Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
Impact of the intervention on caregiver stress and burden via ZBI-12 (Zarit Caregiver Burden Assessment)
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 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 17 Jul 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.
Dr Laura BG Tay, MBBS, MMed, MRCP, MCI contact
Prof Teh Bin Tean, MBBS, PhD principal investigator
National Cancer Centre, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Mild Cognitive Impairment and Mild Dementia, run by National Cancer Centre, Singapore at 2 sites in Singapore.
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 9 inclusion and 10 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 17 Jul 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 Singapore. 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 Prof Teh Bin Tean, MBBS, PhD (+65 66011324, teh.bin.tean@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of an olfactory enrichment program in improving the well-being of patients with mild cognitive impairment (MCI) and dementia. (time frame: Mid-intervention (12 weeks), and post intervention (24 weeks).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.