No Intervention: Participants randomised to the control group will only complete the behavioural and caregiver assessments.
Aromatherapy: 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 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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
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.
* 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.
Exclusion Criteria:
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.
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.
Primary outcome measure(s)
Feasibility and acceptability of an olfactory enrichment program in improving the well-being of patients with mild cognitive impairment (MCI) and dementia. — 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. — 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. — 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.
Trial sites (2)
Facility
City
Region
Status
National Cancer Centre Singapore
Singapore
Singapore
Recruiting
Sengkang General Hospital
Singapore
Singapore
Recruiting
More National Cancer Centre, Singapore trials in Singapore
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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