Lighting Intervention
DeviceLighting Intervention consisting of a cool or warm light source.
NCT Number: NCT04073628
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.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Icahn School of Medicine at Mount Sinai, Albany, New York, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for MCI/Mild AD Participant:
Exclusion criteria
for MCI/Mild AD Participant:
For caregivers, we will accept those who:
Lighting Intervention consisting of a cool or warm light source.
Time frame: Will be administered at baseline and the end of weeks 9, 17, 25 and 37
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.
Time frame: Will be administered at baseline and the end of weeks 9, 17, 25 and 37
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.
Icahn School of Medicine at Mount Sinai
Other
The Long-term Impact of a Light Intervention on Sleep Physiology and Cognition in Mild Cognitive Impairment
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