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

National Cancer Centre, Singapore

Status

Not yet enrolling

Conditions

Mild Dementia

Mild Cognitive Impairment

Treatments

Other: No Intervention

Other: Aromatherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07234357

2025/0299

Details and patient eligibility

About

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.

Full 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 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)
Mini-mental state examination (MMSE)
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.

Enrollment

200 estimated patients

Sex

All

Ages

50 to 99 years old

Volunteers

No Healthy Volunteers

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.