Aromatherapy for Mild Cognitive Impairment and Mild Dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SENSE is a non-blinded, interventional study enrolling about 200 patient–caregiver pairs from Singapore. Participants are randomized to receive either standard care or an aromatherapy package including a diffuser, a proprietary essential oil blend, and a diary, with guidance to diff use twice daily for at least 5 minutes. Caregivers and patients complete cognitive and behavioral assessments at baseline, 12 weeks, and 24 weeks, and caregivers are monitored for burden and mood. The study aims to gauge long-term adherence and safety of supervised aromatherapy in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Cancer Centre Singapore
  Singapore, Singapore Recruiting
• Sengkang General Hospital
  Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Prof Teh Bin Tean, MBBS, PhD — National Cancer Centre, Singapore
• Study coordinator: Prof Teh Bin Tean, MBBS, PhD
• Email: teh.bin.tean@singhealth.com.sg
• Phone: +65 66011324

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.