Sensory Enrichment for Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Evaluation of behavioral pattern separation ability
研究概览
简要总结
This study evaluates the efficacy of multi-odorant enrichment on cognitive skills, olfactory function, and quality of life.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both the participants and the assessors will be blinded to the group assignments.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Evaluation of behavioral pattern separation ability
时间窗: 1) at Baseline and 2) after 6 months of intervention
Change in lure discrimination index on a computerized mnemonic discrimination task.
次要结局
- 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 cognition(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)
- Evaluation of change in brain structures(1) at Baseline and 2) after 6 months of intervention)
研究者
Michael Leon
Professor
University of California, Irvine