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Behavioural Intervention
Dynamic Lighting for Dementia
N/A
Waitlist Available
Led By Nina Sharp, PhD
Research Sponsored by Arizona State University
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 24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.
Summary
This trial uses special lighting to help older adults with dementia in long-term care facilities. The lighting mimics natural daylight patterns to improve their sleep and mood.
Who is the study for?
This trial is for older adults over 50 with mild to major dementia who are not currently using light therapy or light-altering devices. They should have no major organ failure, significant additional diagnoses, history of head injury, obstructing cataracts, macular degeneration, or blindness.
What is being tested?
The study tests dynamic lighting that changes intensity and spectrum throughout the day against placebo lighting in long-term care facilities. It aims to see if this can improve sleep quality, circadian rhythms, and mood in older adults with dementia.
What are the potential side effects?
Since this trial involves lighting interventions rather than medication or invasive procedures, side effects may be minimal but could include discomfort due to changes in light exposure or potential disruption of usual sleep patterns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Nocturnal Sleep Duration (in minutes) as measured by actigraphy
Change in Percent Sleep Efficiency (total sleep time divided by time in bed) measured by actigraphy.
Changes in agitation levels measured by Cohen-Mansfield Agitation Inventory (CMAI).
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Placebo Condition followed by Dynamic ConditionExperimental Treatment2 Interventions
Each lighting condition will last for three weeks (Weeks 2-4 or 5-7). The order of conditions will be randomized. Sleep data will be collected only on the last 7 days of each condition using actigraphy. Light spectrum and intensity will be tracked continuously throughout the waking hours (wearable light tracker). Moreover, caregivers will complete two questionnaires (CSDD and CMAI) every seven days to assess the short and long-term effects of each condition on mood and agitation of older adult participants.
Group II: Dynamic Condition followed by Placebo ConditionExperimental Treatment2 Interventions
Each lighting condition will last for three weeks (Weeks 2-4 or 5-7). The order of conditions will be randomized. Sleep data will be collected only on the last 7 days of each condition using actigraphy. Light spectrum and intensity will be tracked continuously throughout the waking hours (wearable light tracker). Moreover, caregivers will complete two questionnaires (CSDD and CMAI) every seven days to assess the short and long-term effects of each condition on mood and agitation of older adult participants.
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Who is running the clinical trial?
Arizona State UniversityLead Sponsor
298 Previous Clinical Trials
107,927 Total Patients Enrolled
5 Trials studying Sleep
279 Patients Enrolled for Sleep
Arizona Alzheimer's ConsortiumUNKNOWN
Arizona State University Knowledge EnterpriseUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are older than 50 years.You have been diagnosed with any level of dementia as determined by your doctor and care facility manager.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Condition followed by Dynamic Condition
- Group 2: Dynamic Condition followed by Placebo Condition
Awards:
This trial has 0 awards, including: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.
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