Cognitive FunctionNCT03914989
Sensory Enrichment for Older Adults
A study testing olfactory enrichment (essential oils) in people with Cognitive Function, run by University of California, Irvine at 1 site in United States.
Trial summary
This study evaluates the efficacy of multi-odorant enrichment on cognitive skills, olfactory function, and quality of life. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- olfactory enrichment (essential oils)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are age 60-85, male or female
- Have normal cognition (determined at first assessment with cognitive testing)
- Speak/read/understand English fluently
- Have visual and auditory acuity adequate for neuropsychological and computerized testing
- Are in good general health with no disease(s) expected to interfere with the study
- Are willing and able to participate for the duration of the study and in all study procedures
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- Are able to smell scents
- Are willing to refrain from using scented candles, scented oils, or air fresheners while participating in the study
- Are willing to travel to the research site for testing
- If interested in functional Magnetic Resonance Imaging (fMRI),
- Are willing and able to participate in the fMRI scan.
Who cannot join
- Have known fragrance sensitivities
- Have asthma, allergies, or a fragrance sensitivity, which produces symptoms similar to those of an allergy, including runny nose, watery eyes, sneezing, or skin rash
- Have a neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm
- Have major health conditions such as uncontrolled diabetes mellitus, uncontrolled hypertension, nutritional deficiency or thyroid disease
- Have significant psychiatric disorders such as schizophrenia, bipolar disorder, anxiety disorder, or attention-deficit hyperactivity disorder
- Have cognitive impairment when tested at baseline (defined as a score on any neuropsychological test of 1.5 standard deviations or more outside the age norm)
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- Have had alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria)
- Smoke cigarettes, e-cigarettes, cigars, marijuana, or any other substance that could produce an interfering odor for the study.
- If interested in functional Magnetic Resonance Imaging (fMRI),
- MRI contraindications, (e.g. pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Irvine
Irvine, California, 92697
About this study
This study evaluates the efficacy of multi-odorant enrichment on cognitive skills, olfactory function, and quality of life.
Read the detailed description
The purpose of this study is to explore sensory stimulation as a potential means of enhancing cognitive abilities. In mice, multi-odorant enrichment has been shown to increase neurogenesis in a critical memory pathway and thereby improve memory. In this clinical study, we will determine if a nightly sensory enrichment regimen using scents for 6 months can improve cognitive skills, as measured using a series of cognitive assessments and brain imaging in older adults. We also will determine if mood/mental state of mind or olfactory functioning improve following scent stimulation.
This study will enroll approximately 200 participants. Of the 200 participants in the study, 50 individuals, who are interested in participating, will have a functional Magnetic Resonance Imaging (fMRI) scan at the beginning and end of the study, which will be used to examine changes in the brain.
Participants will undergo cognitive assessments, computerized cognitive assessments, and olfactory function assessments. They will be randomly assigned to either an experimental or an active control group, and will be exposed to either a higher or lower concentration of essential oils nightly using a nebulizing fragrance diffuser, rotating through seven different scents, one per night. The exposures will continue for 6 months, after which the participants will return and undergo the same assessments conducted at the beginning of the study.
- Conditions
- Cognitive Function
- Being tested
- olfactory enrichment (essential oils)
- Keywords
- Memory preservation, Age-related memory disorders, Intervention, Life quality, Olfaction
- Medical subject headings
- Memory Disorders, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory enrichment (essential oils)Other
Participants will be exposed to either a higher or lower concentration of essential oils nightly for two hours as they are going to sleep, using a nebulizing fragrance diffuser, rotating through seven different scents, one per night.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Individuals in this group receive exposure to a higher concentration of essential oil fragrances nightly. Receives: Other: olfactory enrichment (essential oils) |
| Active control group | Placebo comparator | Individuals in this group receive exposure to a lower concentration of essential oil fragrances nightly. Receives: Other: olfactory enrichment (essential oils) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of behavioral pattern separation ability
Change in lure discrimination index on a computerized mnemonic discrimination task.
Measured: 1) at Baseline and 2) after 6 months of intervention
Secondary outcomes (6)
Evaluation of cognition
Change in cognitive ability will be measured using scores from a neuropsychological battery. For each subsection, a change score will be calculated using the difference between baseline and 6-month scores, and the change score will be compared between groups. Higher values indicate a better outcome.
Measured: 1) at Baseline and 2) after 6 months of intervention
Evaluation of depression
Change in depression status using the Beck Depression Inventory.
Measured: 1) at Baseline and 2) after 6 months of intervention
Evaluation of quality of life
Change in quality of life using the Farage Quality of Life questionnaire.
Measured: 1) at Baseline and 2) after 6 months of intervention
Evaluation of olfactory function
Change from baseline score on the Sniffin' Sticks instrument to assess olfactory system functioning.
Measured: 1) at Baseline and 2) after 6 months of intervention
Evaluation of change in brain structural connectivity
Change in perforant path integrity using functional Magnetic Resonance Imaging.
Measured: 1) at Baseline and 2) after 6 months of intervention
Evaluation of change in brain structures
Change in thickness of entorhinal cortex using functional Magnetic Resonance Imaging.
Measured: 1) at Baseline and 2) after 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start8 Mar 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Unable to complete full enrollment due to Covid pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an experimental group or an active control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Principal investigator, Michael Leon, University of California, Irvine
- Investigators
- Michael Leon, PhD, Principal investigator, University of California, IrvineMichael Yassa, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914989
- Sponsor's protocol ID
- 2014-1078
- Status last verified
- Feb 2023
- First submitted
- 10 Apr 2019
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Enrichment for Older Adults
- ClinicalTrials.gov ID
- NCT03914989
- Acronym / sponsor ID
- 2014-1078
- Conditions
- Cognitive Function
- Keywords
- Memory preservation, Age-related memory disorders, Intervention, Life quality, Olfaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to complete full enrollment due to Covid pandemic.
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy of multi-odorant enrichment on cognitive skills, olfactory function, and quality of life.
Detailed description
The purpose of this study is to explore sensory stimulation as a potential means of enhancing cognitive abilities. In mice, multi-odorant enrichment has been shown to increase neurogenesis in a critical memory pathway and thereby improve memory. In this clinical study, we will determine if a nightly sensory enrichment regimen using scents for 6 months can improve cognitive skills, as measured using a series of cognitive assessments and brain imaging in older adults. We also will determine if mood/mental state of mind or olfactory functioning improve following scent stimulation.
This study will enroll approximately 200 participants. Of the 200 participants in the study, 50 individuals, who are interested in participating, will have a functional Magnetic Resonance Imaging (fMRI) scan at the beginning and end of the study, which will be used to examine changes in the brain.
Participants will undergo cognitive assessments, computerized cognitive assessments, and olfactory function assessments. They will be randomly assigned to either an experimental or an active control group, and will be exposed to either a higher or lower concentration of essential oils nightly using a nebulizing fragrance diffuser, rotating through seven different scents, one per night. The exposures will continue for 6 months, after which the participants will return and undergo the same assessments conducted at the beginning of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an experimental group or an active control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: olfactory enrichment (essential oils)Individuals in this group receive exposure to a higher concentration of essential oil fragrances nightly. |
| Active control group | Placebo comparator | Other: olfactory enrichment (essential oils)Individuals in this group receive exposure to a lower concentration of essential oil fragrances nightly. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Are age 60-85, male or female
- Have normal cognition (determined at first assessment with cognitive testing)
- Speak/read/understand English fluently
- Have visual and auditory acuity adequate for neuropsychological and computerized testing
- Are in good general health with no disease(s) expected to interfere with the study
Key exclusion criteria (10 listed)
- Have known fragrance sensitivities
- Have asthma, allergies, or a fragrance sensitivity, which produces symptoms similar to those of an allergy, including runny nose, watery eyes, sneezing, or skin rash
- Have a neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm
- Have major health conditions such as uncontrolled diabetes mellitus, uncontrolled hypertension, nutritional deficiency or thyroid disease
- Have significant psychiatric disorders such as schizophrenia, bipolar disorder, anxiety disorder, or attention-deficit hyperactivity disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olfactory enrichment (essential oils)Participants will be exposed to either a higher or lower concentration of essential oils nightly for two hours as they are going to sleep, using a nebulizing fragrance diffuser, rotating through seven different scents, one per night. | Other | Active control group, Experimental group |
Primary outcome
Evaluation of behavioral pattern separation ability
Time frame: 1) at Baseline and 2) after 6 months of intervention
Change in lure discrimination index on a computerized mnemonic discrimination task.
6 secondary outcomes
Evaluation of cognition
Time frame: 1) at Baseline and 2) after 6 months of intervention
Evaluation of depression
Time frame: 1) at Baseline and 2) after 6 months of intervention
Evaluation of quality of life
Time frame: 1) at Baseline and 2) after 6 months of intervention
Evaluation of olfactory function
Time frame: 1) at Baseline and 2) after 6 months of intervention
Evaluation of change in brain structural connectivity
Time frame: 1) at Baseline and 2) after 6 months of intervention
Evaluation of change in brain structures
Time frame: 1) at Baseline and 2) after 6 months of intervention
Results and safety
The study was stopped early (reason given: Unable to complete full enrollment due to Covid pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Leon, PhD principal investigator
University of California, Irvine
Michael Yassa, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olfactory enrichment (essential oils) in people with Cognitive Function, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to complete full enrollment due to Covid pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of behavioral pattern separation ability (time frame: 1) at Baseline and 2) after 6 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.