Sensory Enrichment for Older Adults

NCT03914989 | Terminated

• 1 other identifier: 2014-1078
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Function

Keywords

Memory preservation; Age-related memory disorders; Intervention; Life quality; Olfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Evaluation of cognition

  1) at Baseline and 2) after 6 months of intervention

• Evaluation of depression

  1) at Baseline and 2) after 6 months of intervention

• Evaluation of quality of life

  1) at Baseline and 2) after 6 months of intervention

• Evaluation of olfactory function

  1) at Baseline and 2) after 6 months of intervention

• Evaluation of change in brain structural connectivity

  1) at Baseline and 2) after 6 months of intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

Individuals in this group receive exposure to a higher concentration of essential oil fragrances nightly.

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.

Other: olfactory enrichment (essential oils)

Interventions

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.

Active control group; Experimental group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)
• 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).

Sponsors & Collaborators

• University of California, Irvine: lead
• Procter and Gamble: collaborator

Study Sites (1)

University of California Irvine

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Memory Disorders; Anosmia

Interventions

Oils, Volatile

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Olfaction Disorders; Sensation Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Michael Leon, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Michael Yassa, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both the participants and the assessors will be blinded to the group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to either an experimental group or an active control group.

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: March 8, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: March 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)