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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG034157-13 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Investigate the long-term impact of amount and duration of Tailored Lighting Intervention (TLI) obtained from Aims 1 and 2 on sleep, cognition, circadian marker, mood, and behavior in AD/ADRD patients. For this single-arm, randomized, placebo-controlled study, the researchers plan to recruit 100 participants who will experience either the active TLI or the placebo for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Lighting Intervention | Active Comparator | Combining spectrum and light level, the active TLI will allow the researchers to use a light source that will stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered. |
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| Control Lighting Intervention | Placebo Comparator | The control TLI will allow the researchers to use a light source that will not stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Lighting Intervention | Device | The TLI will allow researchers to use a light source that will control how the circadian system is stimulated and provide the participants with options as to how the light treatment will be delivered. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Disturbance using the Pittsburgh Sleep Quality Index (PSQI) | 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 full scale range of 0 to 21. A higher score indicates higher sleep disturbance. | Up to Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep efficiency using actigraphy | 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 | Up to Week 36 |
| Depression using the Cornell Scale for Depression in Dementia (CSDD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariana Figueiro, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Menands | New York | 12204 | United States | ||
| Icahn School of Medicine at Mount Sinai |
Overall results will be shared not individual
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| Control Lighting Intervention | Device | The TLI will allow researchers to use a light source that will not stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered. |
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The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. Full Scale ranges from 0 to 38 with a higher score indicating greater depression. |
| Up to Week 36 |
| Agitation using the Cohen-Mansfield Agitation Inventory (CMAI) | 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. | Up to Week 36 |
| Light measurements using the Daysimeter | 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. | Up to Week 36 |
| Cognitive status Using the Montreal Cognitive Assessment (MOCA) | 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. | Up to Week 36 |
| New York |
| New York |
| 10029 |
| United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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