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

NCT07234357 | Not Yet Recruiting

• 1 other identifier: 2025/0299
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mild Cognitive Impairment; Mild Dementia

Keywords

Aromatherapy; Diffusion Aromatherapy; Essential Oils; Mild Cognitive Impairment (MCI); Mild Dementia; Dementia; Caregiver Burden; Caregiver Stress; Elderly Compliance; Caregiver

Outcome Measures

Primary Outcomes (3)

• 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 Patients that are unable to meet the minimum of 50% compliance will be withdrawn from the study.

  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.

  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.

  Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).

Secondary Outcomes (3)

• Preliminary efficacy of the intervention in maintaining cognitive function in patients with MCI and dementia.

  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)

  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)

  Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).

Study Arms (2)

Control Group

EXPERIMENTAL

Other: No Intervention

Intervention Group

EXPERIMENTAL

Other: Aromatherapy

Interventions

No Intervention OTHER

Participants randomised to the control group will only complete the behavioural and caregiver assessments.

Control Group

Aromatherapy OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Temasek Foundation: collaborator

Study Sites (2)

National Cancer Centre Singapore

Singapore, 168583, Singapore

Location

Sengkang General Hospital

Singapore, 544886, Singapore

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Caregiver Burden

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Prof Teh Bin Tean, MBBS, PhD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof Teh Bin Tean, MBBS, PhD

CONTACT

+65 66011324; teh.bin.tean@singhealth.com.sg

Dr Laura BG Tay, MBBS, MMed, MRCP, MCI

CONTACT

laura.tay.b.g@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Only the intervention group will receive the aromatherapy diffusion, while the control group will not.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

SG (2)