Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sensory Enrichment for Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03914989
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Michael Leon, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE April 15, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE March 8, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03914989 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2019)
  • Evaluation of cognition [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    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.
  • Evaluation of depression [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    Change in depression status using the Beck Depression Inventory.
  • Evaluation of quality of life [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    Change in quality of life using the Farage Quality of Life questionnaire.
  • Evaluation of olfactory function [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    Change from baseline score on the Sniffin' Sticks instrument to assess olfactory system functioning.
  • Evaluation of change in brain structural connectivity [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    Change in perforant path integrity using functional Magnetic Resonance Imaging.
  • Evaluation of change in brain structures [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    Change in thickness of entorhinal cortex using functional Magnetic Resonance Imaging.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Evaluation of cognition [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    Change in cognitive ability using scores from a neuropsychological battery.
  • Evaluation of depression [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    Change in depression status using the Beck Depression Inventory.
  • Evaluation of quality of life [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    Change in quality of life using the Farage Quality of Life questionnaire.
  • Evaluation of olfactory function [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    Change from baseline score on the Sniffin' Sticks instrument to assess olfactory system functioning.
  • Evaluation of change in brain structural connectivity [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    Change in perforant path integrity using functional Magnetic Resonance Imaging.
  • Evaluation of change in brain structures [ Time Frame: 1) at Baseline and 2) after 6 months of intervention ]
    Change in thickness of entorhinal cortex using functional Magnetic Resonance Imaging.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sensory Enrichment for Older Adults
Official Title  ICMJE Sensory Enrichment for Older Adults
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to either an experimental group or an active control group.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Both the participants and the assessors will be blinded to the group assignments.
Primary Purpose: Prevention
Condition  ICMJE Cognitive Function
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Experimental group
    Individuals in this group receive exposure to a higher concentration of essential oil fragrances nightly.
    Intervention: Other: olfactory enrichment (essential oils)
  • Placebo Comparator: Active control group
    Individuals in this group receive exposure to a lower concentration of essential oil fragrances nightly.
    Intervention: Other: olfactory enrichment (essential oils)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Blake A Miranda, BS 949-824-0904 bamirand@uci.edu
Contact: Michael Leon, PhD 949-237-3026 mleon@uci.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03914989
Other Study ID Numbers  ICMJE 2014-1078
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Leon, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Procter and Gamble
Investigators  ICMJE
Principal Investigator: Michael Leon, PhD University of California, Irvine
Principal Investigator: Michael Yassa, PhD University of California, Irvine
PRS Account University of California, Irvine
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP