Sense4Safety for Mild Cognitive Impairment

(Sense4Safety Trial)

Overseen By Sean Harrison, MPH

Age: 65+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Pennsylvania

Disqualifiers: Terminal illness, Stroke, Parkinson's, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Sense4Safety, which aims to reduce the risk of falls in older adults with mild cognitive impairment (MCI). Falls pose a significant concern for seniors, often leading to injuries and high medical costs. Sense4Safety uses sensors and machine learning to monitor fall risks and connects participants with a coach to create personalized fall-prevention plans. The study seeks individuals aged 65 and older who live in senior communities, have mild memory issues (MCI), and can walk short distances. Participants will either join the control group, receiving standard care, or the intervention group, using the Sense4Safety system. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to experience this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Sense4Safety intervention is safe for older adults with mild cognitive impairment?

Research has shown that older adults with mild memory problems generally receive the Sense4Safety technology well. In one study involving 11 older adults, participants used the Sense4Safety system for three months. Most found it helpful and felt safer, with no major safety issues reported. Another study assessing the practicality of Sense4Safety also received positive feedback, indicating it is safe.

Since Sense4Safety remains in the early testing stages, the focus is on safety. While some caution is necessary, early results are promising regarding its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Sense4Safety for Mild Cognitive Impairment because it offers a new approach compared to traditional medications, which often focus on symptom management. Unlike typical drug treatments, Sense4Safety is an innovative intervention that likely involves a different method, such as a digital tool or cognitive training program, aimed at improving cognitive safety and functionality. This novel approach could provide a more holistic and non-invasive way to support individuals with mild cognitive impairment, potentially enhancing quality of life without the side effects associated with pharmaceuticals.

What evidence suggests that Sense4Safety is effective for reducing fall risk in older adults with mild cognitive impairment?

Research shows that Sense4Safety might help reduce falls in older adults with mild memory problems. Studies have found that more than 60% of these adults fall each year. In this trial, participants in the intervention group will receive the Sense4Safety system, which uses home sensors and smart technology to monitor fall risks in real time. It also connects users with a coach to create personalized plans to reduce their risk of falling. Early tests have shown that older adults find this technology easy to use and helpful. While more research is needed to confirm its effectiveness, this new approach looks promising for helping this vulnerable group. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 65 or older who live in senior communities, can walk around their home, and have mild cognitive impairment (MCI). They should plan to stay in the area for over 6 months and score at least a 6 on a physical performance test. People with severe mobility or cognitive issues may not qualify.

Inclusion Criteria

I am 65 years old or older.

I live in a senior living community and will stay in the area for over 6 months.

I can walk around my house.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Sense4Safety Intervention, which includes in-home passive sensor monitoring and individualized alerts for fall risk

6 months

Regular in-home monitoring

Control

Participants in the control group receive no interventional component, standard care

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Sense4Safety

Trial Overview

The Sense4Safety intervention uses sensors to monitor fall risk in real-time, machine learning for personalized fall risk alerts, and coaching to help implement plans to reduce this risk. The study aims to see if it effectively lowers the chance of falls among older adults with MCI.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Participants receive the Sense4Safety Intervention

Group II: Control Group Active Control 1 Intervention

Participants receive no interventional component, standard care

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12340378/

Feasibility and Acceptability of a Technology-Mediated Fall ...

Mild cognitive impairment (MCI) is a leading risk factor for falls in OA. Approximately 15%–20% of OA have MCI, and over 60% of OA with MCI fall annually—2–3 ...

2.

mdpi.com

mdpi.com/2227-9032/10/5/862

The Effects of Combined Physical and Cognitive ...

This study indicated that combining PCT improves balance ability, gait speed, and executive functioning in the elderly with MCI, which may help to minimize ...

3.

researchgate.net

researchgate.net/publication/376724503_A_TECHNOLOGY_SUPPORTED_FALL_PREVENTION_INTERVENTION_FOR_OLDER_ADULTS_WITH_MILD_COGNITIVE_IMPAIRMENT

a technology supported fall prevention intervention for ...

The goal of this study was to access the feasibility of Sense4Safety and its acceptability. We recruited 10 low-income OA with MCI; each ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40037579/

Feasibility and Acceptability of a Technology-Mediated Fall ...

The purpose of this study was to assess the feasibility and acceptability of the Sense4Safety intervention through participant interviews.

5.

agmr.hapres.com

agmr.hapres.com/UpLoad/PdfFile/AGMR_1565.pdf

Meta-Analysis-Based Comparison of Annual Fall Risk ...

This meta-analysis summarized previous studies reporting the annual fall risk of people with Alzheimer's disease (AD) or mild cognitive ...

6.

longevityfederation.com

longevityfederation.com/news/reducing-fall-risk-in-older-adults-with-mild-cognitive-impairment/

Reducing Fall Risk in Older Adults with Mild Cognitive Impairment

The study enrolled 11 adults aged 65 and older with mild cognitive impairment (MCI) to receive the Sense4Safety intervention for three months. People with MCI, ...

7.

penntoday.upenn.edu

penntoday.upenn.edu/news/penn-nursing-preventing-falls-older-adults-mild-cognitive-impairment

Preventing falls in older adults with mild cognitive impairment

The study finds that most participants found the intervention to be useful, providing them with a sense of safety and helping them be more aware ...