Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2
Study Details
Study Description
Brief Summary
Aim 2 will investigate the effect of 3 different light exposure lengths on sleep, mood and agitation in persons with Alzheimer's disease. Participants will be randomly assigned to one of three conditions of light exposure: 1) 2-h morning light exposure; 2) 4-h morning light exposure; and 3) all day light exposure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Lighting Intervention Lighting intervention designed to effect the circadian system then will receive the control lighting intervention. |
Device: Active Lighting Intervention
Lighting intervention using high light levels designed to effect the circadian system
Device: Control Lighting Intervention
Lighting intervention using low light levels designed to not effect the circadian system
|
| Placebo Comparator: Control Lighting Intervention Lighting intervention using low light levels designed to not effect the circadian system |
Device: Control Lighting Intervention
Lighting intervention using low light levels designed to not effect the circadian system
|
Outcome Measures
Primary Outcome Measures
- Sleep Disturbance using the Pittsburgh Sleep Quality Index [up to week 14]
The PSQI is used to measure sleep quality and is composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each subscale is scored 0 to 3. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A higher score indicates higher sleep disturbance
Secondary Outcome Measures
- Sleep efficiency using actigraphy [up to week 14]
Actigraphs will be worn continuously for 7 days during each assessment week. Changes in sleep efficiency will be measured using the actigraphy software. Sleep efficiency is a calculated as a ratio of the time spent in bed and the time spent sleeping.
- Depression using the Cornell Scale for Depression in Dementia (CSDD) [up to week 14]
The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. This tool evaluates the presence and extent of mood-related signs (anxiety, sadness, irritability), behavioral disturbances (agitation, loss of interest), physical signs (loss of appetite, weight loss), cyclic functions (mood variation, sleep quality), and ideational disturbances. Scores range from 0 to 38 with a higher score indicating greater depression.
- Agitation using the Cohen-Mansfield Agitation Inventory (CMAI) [up to week 14]
The CMAI assesses the frequency of manifestations of agitated behaviors in elderly persons. The CMAI is a caregivers' rating questionnaire consisting of 29 agitated behaviors, each rated on a 7-point scale of frequency. Score ranges from 30 to 210 with a higher score indicating higher agitated behavior.
- Light measurements using the Daysimeter [up to week 14]
Circadian light measurements will be collected during waking hours for 7 days each assessment week using the daysimeter. The light measurement is reported as Lux levels.
- Cognitive status Using the Montreal Cognitive Assessment (MOCA) [up to week 14]
The MoCA is a 1-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. Total score range from 0 to 30. Lower score indicates lower cognitive status.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score <25
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Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5
Exclusion Criteria:
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Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease
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Obstructing cataracts
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Severe macular degeneration
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Use of sleep medication
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Use of oral melatonin
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untreated moderate to severe sleep apnea
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Severe restless leg syndrome
-
Blindness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Icahn School of Medicine at Mount Sinai | Albany | New York | United States | 12204 |
| 2 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
Sponsors and Collaborators
- Icahn School of Medicine at Mount Sinai
Investigators
- Principal Investigator: Mariana Figueiro, PhD, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY-20-01736