NCT07234357

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Mild Cognitive Impairment
• Mild Dementia

Interventions

Type	Name	Description
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 daily compliance, record adverse events, and document the number of minutes used each night.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

2 sites across 1 country: Singapore