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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG062288 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Rutgers University | OTHER |
| National Institute on Aging (NIA) | NIH |
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To investigate the impact of a long-term light treatment intervention on sleep physiology and memory in mild cognitively impaired and mild Alzheimer's disease patients living at home. The goal is also to measure the impact of the lighting intervention on caregivers' sleep, cognition, depression, and quality of life.
The current application proposes to investigate the impact of a long-term light treatment intervention on sleep physiology and sleep-dependent cognitive processes in mild cognitive impairment (MCI) and mild Alzheimer's disease (AD) patients. The premise is that older adults, especially those with cognitive impairment, are often in continuous dim light, which leads to circadian misalignment. Circadian misalignment impacts the close relationship between homeostatic and circadian processes, which can reduce memory-related sleep features. The hypothesis is that a lighting intervention technology (LIT), designed to promote circadian entrainment, will improve sleep by aligning the two sleep processes (circadian and homeostatic) and, thus improve cognition. In addition to improving patients' lives, LIT has the potential to reduce the overnight burden on caregivers. Thus, an exploratory goal is to also measure the impact of LIT on caregivers' sleep, cognition, depression, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Lighting intervention | Active Comparator | The active lighting intervention will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. Combining spectrum and light level, the intervention will allow us to: (1) use a light source that will stimulate the circadian system and (2) 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 lighting intervention will consist of low levels of a warm light source designed not to impact the circadian system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lighting Intervention | Device | Lighting Intervention consisting of a cool or warm light source. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cognition using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) | Change in cognition of the MCI participant will be assessed utilizing the Alzheimer's Disease Assessment Scale-Cognitive to capture subtler changes in cognitive performance. The ADAS-Cog is the most widely used general cognitive measure in clinical trials of Alzheimer's disease. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation. | Will be administered at baseline and the end of weeks 9, 17, 25 and 37 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality in the MCI Participant using the Pittsburgh Sleep Quality Index (PSQI) | Change in sleep quality of the MCI participant will be assessed utilizing the Pittsburgh Sleep Quality Index (PSQI). The PSQI is composed of 19 items that generate seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). The sum of the seven component scores yields a single global score. A global score >5 is considered to indicate sleep disturbances. A lower score indicates improvement in sleep quality. |
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Inclusion Criteria for MCI/Mild AD Participant:
Exclusion Criteria for MCI/Mild AD Participant:
For caregivers, we will accept those who:
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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 | Albany | New York | 12204 | United States | ||
| Icahn School of Medicine at Mount Sinai |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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In a single-arm, randomized, placebo-controlled (non-active comparison lighting intervention), between-subjects study, we will investigate the effect of long-term exposure (6 months) to a lighting intervention, which is designed to promote circadian entrainment.
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| Will be administered at baseline and the end of weeks 9, 17, 25 and 37 |
| New York |
| New York |
| 10029 |
| United States |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |