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Novel Lighting for Fall Prevention in Dementia
N/A
Waitlist Available
Led By Sheryl Zimmerman, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion (one year)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test lights that outline doorframes to reduce falls in dementia patients in assisted living homes.
Who is the study for?
This trial is for assisted living residents with dementia who try to get out of bed, are not wheelchair-bound, blind, on hospice care, or expected to die/transfer within the study year. They must live alone in a room but can share a bathroom.
What is being tested?
The study tests if special lights around doorframes can reduce nighttime falls in people with dementia. It's a one-year crossover trial where participants experience both the new lighting and regular conditions at different times.
What are the potential side effects?
Since this intervention involves lighting changes rather than medication, side effects may include discomfort from the light or dissatisfaction with the system but no medical side effects are anticipated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study completion (one year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion (one year)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Falls incidence density ratio
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Lighting Sequence 4: LLCCExperimental Treatment2 Interventions
In this arm, the participant will receive the novel lighting condition (L) for the first two quarters (180 days) and then crossover to the control lighting condition (C) for the last two quarters (180 days).
Q1 - Novel lighting Q2 - Novel lighting Q3 - Control lighting Q4 - Control lighting
Group II: Lighting Sequence 3: LCCLExperimental Treatment2 Interventions
In this arm, the participant will receive the novel lighting condition (L) for the first quarter (90 days) and then crossover to the control lighting condition (C) for the next two quarters (180 days) and finally crossover again to the novel condition (L) for the last quarter (90 days).
Q1 - Novel lighting Q2 - Control lighting Q3 - Control lighting Q4 - Novel lighting
Group III: Lighting Sequence 2: CLLCExperimental Treatment2 Interventions
In this arm, the participant will receive the control lighting condition (C) for the first quarter (90 days) and then crossover to the novel lighting condition (L) for the next two quarters (180 days) and finally crossover again to the control condition (C) for the last quarter (90 days).
Q1 - Control lighting Q2 - Novel lighting Q3 - Novel lighting Q4 - Control lighting
Group IV: Lighting Sequence 1: CCLLExperimental Treatment2 Interventions
In this arm, the participant will receive the control lighting condition (C) for the first two quarters (180 days) and then crossover to the novel lighting condition (L) for the last two quarters (180 days).
Q1 - Control lighting Q2 - Control lighting Q3 - Novel lighting Q4 - Novel lighting
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,561 Previous Clinical Trials
4,298,391 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,792 Previous Clinical Trials
28,191,504 Total Patients Enrolled
Sheryl Zimmerman, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
3 Previous Clinical Trials
4,960 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with dementia.Not applicable.I try to get out of bed.I do not share a bedroom, but it's okay if I share a bathroom.I do not use a wheelchair for mobility.
Research Study Groups:
This trial has the following groups:- Group 1: Lighting Sequence 3: LCCL
- Group 2: Lighting Sequence 1: CCLL
- Group 3: Lighting Sequence 2: CLLC
- Group 4: Lighting Sequence 4: LLCC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.