Sensory Enrichment for Older Adults

Cognitive Function Clinical Trial

Official title:

Sensory Enrichment for Older Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03914989
• Other study ID #: 2014-1078
• Status: Terminated
• Phase: N/A
• Start date: March 8, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the efficacy of multi-odorant enrichment on cognitive skills, olfactory function, and quality of life.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Are age 60-85, male or female

2. Have normal cognition (determined at first assessment with cognitive testing)

3. Speak/read/understand English fluently

4. Have visual and auditory acuity adequate for neuropsychological and computerized testing

5. Are in good general health with no disease(s) expected to interfere with the study

6. Are willing and able to participate for the duration of the study and in all study procedures

7. Are able to smell scents

8. Are willing to refrain from using scented candles, scented oils, or air fresheners while participating in the study

9. Are willing to travel to the research site for testing

If interested in functional Magnetic Resonance Imaging (fMRI),

10. Are willing and able to participate in the fMRI scan.

Exclusion Criteria:

1. Have known fragrance sensitivities

2. 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

3. Have a neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm

4. Have major health conditions such as uncontrolled diabetes mellitus, uncontrolled hypertension, nutritional deficiency or thyroid disease

5. Have significant psychiatric disorders such as schizophrenia, bipolar disorder, anxiety disorder, or attention-deficit hyperactivity disorder

6. 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)

7. Have had alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria)

8. 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),

9. MRI contraindications, (e.g. pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body).

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of California Irvine	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of behavioral pattern separation ability	Change in lure discrimination index on a computerized mnemonic discrimination task.	1) at Baseline and 2) after 6 months of intervention
Secondary	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.	1) at Baseline and 2) after 6 months of intervention
Secondary	Evaluation of depression	Change in depression status using the Beck Depression Inventory.	1) at Baseline and 2) after 6 months of intervention
Secondary	Evaluation of quality of life	Change in quality of life using the Farage Quality of Life questionnaire.	1) at Baseline and 2) after 6 months of intervention
Secondary	Evaluation of olfactory function	Change from baseline score on the Sniffin' Sticks instrument to assess olfactory system functioning.	1) at Baseline and 2) after 6 months of intervention
Secondary	Evaluation of change in brain structural connectivity	Change in perforant path integrity using functional Magnetic Resonance Imaging.	1) at Baseline and 2) after 6 months of intervention
Secondary	Evaluation of change in brain structures	Change in thickness of entorhinal cortex using functional Magnetic Resonance Imaging.	1) at Baseline and 2) after 6 months of intervention