Sensory Intervention for Dementia

(EASE Trial)

Overseen By Justine S Sefcik, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Blind, deaf, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with dementia using calming nature scenes and sounds, known as the Environmental And Sensory Experience (EASE) intervention. The goal is to determine if these sensory experiences can reduce persistent vocalizations (frequent, uncontrolled speaking or noises). Participants will wear a watch to measure stress and observe changes in their vocal patterns. It suits those diagnosed with severe dementia who need assistance moving or cannot walk independently. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that could improve the quality of life for those with severe dementia.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Environmental And Sensory Experience (EASE) intervention is safe for persons with dementia?

Research has shown that the Environmental And Sensory Experience (EASE) intervention is safe for people with dementia. One study found that activities involving multiple senses, like EASE, greatly reduced restlessness in older adults with dementia, indicating the intervention is generally well-received. No harmful effects occurred during these activities.

Another study on similar environment-based activities demonstrated positive effects on behavior without negative side effects. Participants benefited without experiencing harm. These findings suggest that the EASE intervention is safe for those who choose to participate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EASE intervention for dementia because it offers a non-drug approach that leverages personalized sensory experiences, which is quite different from standard treatments like medications aimed at slowing cognitive decline. This method utilizes a tailored projection of nature scenes with matching sounds, creating a calming and engaging environment that may improve mood and reduce anxiety in individuals with dementia. Unlike traditional therapeutic options, which often take time to show benefits and can have side effects, EASE provides an immediate sensory experience with potential for instant emotional impact, making it a promising alternative or complement to existing therapies.

What evidence suggests that the EASE intervention is effective for dementia?

Research shows that nature-based activities, such as the Environmental And Sensory Experience (EASE), can benefit people with dementia. Studies have found that these activities may enhance quality of life by providing a calming environment. Sensory activities, including sights and sounds, can reduce behaviors like constant talking or shouting. Evidence suggests these activities relieve stress and boost mood. Overall, the EASE approach appears promising for aiding people with dementia through carefully selected nature scenes and sounds. ^{1 4 6 7 8}

Who Is on the Research Team?

Justine S Sefcik

Principal Investigator

Drexel University

Are You a Good Fit for This Trial?

This trial is for nursing home residents with dementia who often make repetitive sounds. Family members must consent and fill out a survey about the resident's nature preferences. The study requires participants to wear a stress-measuring watch.

Inclusion Criteria

Consent will be obtained from the resident's Legally Authorized Representative (LAR) and assent from the resident.

I have been diagnosed with dementia.

I am 65 years old or older.

Exclusion Criteria

I am legally blind.

My background includes diverse gender, race, and ethnicity.

I have not expressed any objections to participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Study personnel observe the nursing home resident to collect data on vocalizing behaviors

12 hours

2 visits (in-person)

Intervention

Participants undergo the EASE intervention with nature scenes and sounds, while wearing a watch to measure stress levels

90 minutes

1 visit (in-person)

Follow-up

Participants are monitored for changes in vocalization patterns and stress levels post-intervention

48 hours

What Are the Treatments Tested in This Trial?

Interventions

• Environmental And Sensory Experience (EASE) intervention

Trial Overview

The EASE intervention, which includes displaying still nature images and playing nature sounds, is being tested to see if it helps reduce persistent vocalizations in people with dementia.

How Is the Trial Designed?

Group I: EASE Intervention Experimental Treatment 1 Intervention

Thirty-two persons with dementia will be exposed by an interventionist to an Environmental And Sensory Experience (EASE) intervention which involves a tailored, person-centered nature scene projected with associated nature sounds. A within-person design will be used where the participants will serve as their own controls and be observed 30 minutes prior to, 30 minutes during, and for 30 minutes directly after EASE.

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Multisensory environments (MSEs) in care homes for people with dementia are often underused due to a lack of proper design and insufficient staff training, despite their potential to reduce anxiety and provide beneficial activities.

The study identified key themes regarding the use of MSEs, highlighting the need for better training for staff and more thoughtful design to enhance engagement and effectiveness for individuals in later stages of dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Multisensory Environment (MSE) in Dementia Care: Examining Its Role and Quality From a User Perspective. Collier, L., Jakob, A.[2018]

A systematic review of 55 studies on sensory stimulation interventions for individuals with dementia found that 30 of these studies reported significant effects, primarily in reducing negative behaviors, although many studies had methodological limitations.

The review categorized various sensory interventions, such as music therapy and aromatherapy, and highlighted the need for further research to better understand their impact on quality of life and communication, especially considering different stages of dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory stimulation for persons with dementia: a review of the literature. Strøm, BS., Ytrehus, S., Grov, EK.[2022]

The scoping review identified 170 studies on sensory interventions for older adults with dementia, categorizing them into ten types, including art, music, and nature, which can significantly impact the quality of life for these individuals.

Emerging trends in the field include the use of nature-based interventions and multi-component approaches that combine cognitive training with sensory experiences, suggesting a shift towards more engaging and holistic treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review: Sensory interventions for older adults living with dementia. Hayden, L., Passarelli, C., Shepley, SE., et al.[2022]

A home-based sensory intervention (SI) for people with mild-to-moderate dementia, which included hearing and vision assessments along with the provision of glasses and hearing aids, led to significant improvements in quality of life and sensory functional ability among participants (n = 19).

Participants reported increased social engagement and reduced dependency on their caregivers, with a notable decrease in the time caregivers spent assisting with daily activities, suggesting that enhancing sensory function can positively impact dementia-related outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an intervention to support hearing and vision in dementia: The SENSE-Cog Field Trial. Leroi, I., Simkin, Z., Hooper, E., et al.[2023]

The study demonstrated that a multisensory environment (MSE) using aromatherapy, color-changing lights, and music can effectively calm Veterans with dementia during bathing, reducing the need for sedatives.

All four participants showed increased positive behaviors and decreased negative behaviors during bathing with the MSE intervention, indicating that this nonpharmacological approach can enhance the overall bathing experience for individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the Feasibility of Multisensory Environments to Improve the Assisted Bathing Experience for Veterans With Dementia: A Clinical Trial. Lorusso, L., Bosch, S., Park, NK., et al.[2022]

Clinical staff education and exposure to multisensory environments (MSE) positively influenced their perceptions of clients with dementia, suggesting that MSEs can enhance caregiver understanding and empathy.

The study highlights the potential of MSEs to improve the quality of care for older individuals with dementia, indicating that their use could lead to better outcomes in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Finding the person the disease has'--the case for multisensory environments. Hope, KW., Easby, R., Waterman, H.[2004]

The study successfully implemented a multifaceted sensory intervention for people with dementia, which included hearing and vision assessments, corrective devices, and support, with no serious adverse events reported.

Participants found the intervention to be acceptable and tolerable, achieving high recruitment and retention rates, indicating that a larger efficacy trial could be feasible with some minor adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an Intervention to Support Hearing and Vision in Dementia: The SENSE-Cog Field Trial. Hooper, E., Simkin, Z., Abrams, H., et al.[2020]

The SENSE-Cog trial will evaluate the effectiveness of a home-based multi-part sensory intervention for 354 individuals with dementia and hearing or vision impairments over 18 weeks, aiming to improve their quality of life and other key outcomes.

If successful, the trial could lead to the development of a toolkit for health and social care providers to implement sensory interventions in routine practice, enhancing the therapeutic management of dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualised sensory intervention to improve quality of life in people with dementia and their companions (SENSE-Cog trial): study protocol for a randomised controlled trial. Regan, J., Frison, E., Collin, F., et al.[2023]

The multisensory intervention using themed boxes, which included olfactory stimuli, successfully engaged people with dementia and facilitated emotional involvement and conversation during group sessions.

Participants reported that the contents of the boxes, particularly the olfactory elements, stimulated memories and provided opportunities for self-expression, highlighting the potential for this approach to enhance the quality of life for individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mementos from Boots multisensory boxes - Qualitative evaluation of an intervention for people with dementia: Innovative practice. Griffiths, S., Dening, T., Beer, C., et al.[2019]

Multi-Sensory Stimulation (MSS) significantly improved immediate behavior and mood in older adults with dementia, leading to increased spontaneous talking, better social interaction, and greater alertness compared to a control group engaged in one-to-one activities.

While both MSS and Activity sessions were effective during the trial, only MSS showed lasting improvements in mood and behavior at home, although no long-term benefits were observed after a month, indicating a need for ongoing intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effects of multi-sensory stimulation (MSS) for people with dementia. Baker, R., Bell, S., Baker, E., et al.[2022]

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