Sensory Enrichment Using Aromatherapy for Neurobehavioral and Psychological Symptoms in Early Dementia

Official title

Sensory Enrichment Using Aromatherapy for Neurobehavioral and Psychological Symptoms in Early Dementia (SENSE)

Overview

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.

Interventions

• Other No Intervention
  Participants randomised to the control group will only complete the behavioural and caregiver assessments.
• Other 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 dai

Primary outcome measures

• 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).]
• 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).]
• 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).]

Secondary outcome measures (3)

• 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Singapore · 2 centers

• National Cancer Centre Singapore — Singapore
• Sengkang General Hospital — Singapore

Identifiers

NCT: NCT07234357 · 2025/0299

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗