An interventional study of No Intervention and Aromatherapy in Mild Cognitive Impairment and Mild Dementia, sponsored by National Cancer Centre, Singapore. Recruiting at 2 sites in Singapore. Open to participants aged 50 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by National Cancer Centre, Singapore · Not applicable, Interventional, and Supportive care
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.
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:
Caregivers:
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 200 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →National Cancer Centre, Singapore is the lead sponsor of 117 studies on the registry; 30 are open to participants now.
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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 patients:
For caregivers:
Exclusion Criteria:
For patients:
For caregivers:
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: No Intervention
Other: Aromatherapy
Participants randomised to the control group will only complete the behavioural and caregiver assessments.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
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.
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)
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.
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)
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.
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
Plan to share: Undecided
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