Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2
- Conditions
- Alzheimer's DiseaseSleep Disturbance
- Interventions
- Device: Active Lighting InterventionDevice: Control Lighting Intervention
- Registration Number
- NCT05837819
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
- Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score <25
- Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5
- Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease
- Obstructing cataracts
- Severe macular degeneration
- Use of sleep medication
- Use of oral melatonin
- untreated moderate to severe sleep apnea
- Severe restless leg syndrome
- Blindness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active Lighting Intervention Active Lighting Intervention Lighting intervention designed to effect the circadian system then will receive the control lighting intervention. Active Lighting Intervention Control Lighting Intervention Lighting intervention designed to effect the circadian system then will receive the control lighting intervention. Control Lighting Intervention Control Lighting Intervention Lighting intervention using low light levels designed to not effect the circadian system
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States