Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-30 @ 4:01 AM
Study NCT ID:
NCT07234357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensory Enrichment Using Aromatherapy for Neurobehavioral and Psychological Symptoms in Early Dementia
Sponsor:
National Cancer Centre, Singapore
Organization:
Study Overview
Official Title:
Sensory Enrichment Using Aromatherapy for Neurobehavioral and Psychological Symptoms in Early Dementia (SENSE)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENSE
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: