- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07688382
The Effect of Lavender Aromatherapy on Cognitive Function in Older Adults With Mild Cognitive Impairment
July 2, 2026 updated by: Yuxin Zhang, China Medical University, China
- To analyze the therapeutic effects of lavender aromatherapy on memory function and overall cognitive function in older adults with Mild Cognitive Impairment (MCI);
- To analyze whether lavender aromatherapy improves executive function, language ability, attention, visuospatial ability, anxiety, depression, quality of life, and sleep in older adults with MCI.
Study Overview
Detailed Description
The intervention protocol was established as follows: Based on the elderly participant's usual bedtime, the time of going to bed was recorded.
The participant was instructed to assume a comfortable sleeping position, use the graduated dropper provided with the essential oil bottle to measure 0.15 ml (approximately 3 drops; theoretically, 0.05 ml per drop) of diluted lavender essential oil, and drip it vertically onto the upper center of a cotton pad.
The cotton pad was then pinned to the collar with a safety pin, and the participant was instructed to inhale the scent evenly for 30 minutes.
Afterward, the intervention staff or caregiver will remove the cotton pad.
The intervention will be conducted 5 days a week for 12 weeks.
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuxin Zhang, Graduate
- Phone Number: 18867845231
- Email: 18867845231@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The MCI mentioned in this study meets the diagnostic criteria proposed by the *Chinese Expert Consensus on the Diagnosis and Treatment of Alzheimer's Disease-Derived Mild Cognitive Impairment (2021)*: cognitive impairment reported by the patient or an informant, or identified by an experienced clinician; objective evidence of impairment in one or more cognitive domains, with episodic memory impairment being the most common; complex instrumental activities of daily living may be mildly impaired, but the ability to perform basic activities of daily living remains independent; the diagnostic criteria for dementia are not met.
- MoCA-Beijing version scores were adjusted for education level: ≤13 for junior high school education or below, ≤19 for high school education, and ≤24 for university education or above; MMSE score >24; ADL score <23.
- Age between 60 and 79 years.
- Normal olfactory function assessed using the "Sniffin' Sticks" test.
- Ability to communicate normally and complete cognitive assessments.
- Residing in a senior care facility with no plans to leave within the next 12 weeks.
Exclusion Criteria:
- Presence of other conditions known to affect cognitive function, such as psychiatric disorders (e.g., schizophrenia, depression).
- History of asthma or any allergic conditions.
- Use of any prescription medications that may impact cognitive function (including psychotropic drugs and others)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Aromatherapy experimental group
Aromatherapy experimental group : Aromatherapy The aromatherapy intervention protocol is as follows: Based on the elderly participant's usual bedtime, record the time they go to bed; instruct them to assume a comfortable sleeping position; using the graduated dropper provided with the essential oil bottle, dispense 0.15 ml (approximately 3 drops; theoretically, 0.05 ml per drop) of diluted lavender essential oil and drip it vertically onto the upper center of a cotton pad; pin the cotton pad to the collar with a safety pin; and have the participant inhale the scent evenly for 30 minutes.
Afterward, the intervention staff or caregiver will remove the cotton pad.
The intervention will be conducted 5 days a week for 12 weeks.
|
Participants in the intervention group will receive aromatherapy inhalation for 30 minutes per session, five times a week, over a period of 12 week
|
|
No Intervention: Control group
no-treatment control group receiving routine health education only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gobal cognitive function
Time Frame: Week 12
|
Use the Mini-Mental State Examination to assess overall cognitive function.
|
Week 12
|
|
Memory
Time Frame: Week 12
|
Use the Auditory Verbal Learning Test to assess memory function.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Language function
Time Frame: Week 12
|
Use the Boston Naming Test to assess Language function
|
Week 12
|
|
Executive function
Time Frame: Week 12
|
Use the TMT-B to assess Executive function
|
Week 12
|
|
Visual space
Time Frame: Week 12
|
Use the Draw-a-Clock Test to assess Visual space
|
Week 12
|
|
Attention
Time Frame: Week 12
|
Use the TMT-A to assess Attention
|
Week 12
|
|
Anxiety
Time Frame: Week 12
|
Use the 15-item Geriatric Depression Scale to assess Anxiety
|
Week 12
|
|
Depression
Time Frame: Week 12
|
Use the 15-item Geriatric Depression Scale to assess Depression
|
Week 12
|
|
Sleep Quality
Time Frame: Week 12
|
Use the Pittsburgh Sleep Quality Index to assess Depression
|
Week 12
|
|
Quality of Life assess
Time Frame: Week 12
|
Use the ShortForm 8 Health Survey Questionnaire to assess Depression
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yuxin Zhang, Graduate, China Medical University, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 2, 2027
Study Registration Dates
First Submitted
July 2, 2026
First Submitted That Met QC Criteria
July 2, 2026
First Posted (Actual)
July 7, 2026
Study Record Updates
Last Update Posted (Actual)
July 7, 2026
Last Update Submitted That Met QC Criteria
July 2, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lun Shen [2025] No. 237
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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