The Long-term Impact of a Light Intervention on Sleep and Cognition in Mild Cognitive Impairment
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: June 14, 2021
End Date: April 01, 2024
- Subject has diagnosis of amnestic mild cognitive impairment (MCI) or mild Alzheimer's disease (AD), as defined by a Montreal Cognitive Assessment (MoCA) score between 17 and 24 and those who fall between 0.5-4.0 and 4.5-9.0 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) instrument
- Subject has sleep disturbance indicated by a score >5 on the Pittsburgh Sleep Quality Index and sleep efficiency below 80% as indicated via actigraphy
- Subject resides in his/her home, independent living, or assisted living facilities with a caregiver. Exclusion Criteria for MCI/Mild AD Participant:
- Subject diagnosed with another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
- Subject resides in a skilled nursing facility or long-term care
- Subject has had recent changes in psychotropics (14 days)
- Subject has major organ failure (e.g., kidney failure)
- Subject has uncontrolled generalized disorders such as hypertension or diabetes
- Subject has obstructing cataracts, macular degeneration, and/or blindness
- Subject has undergone cataract surgery and received an intraocular lens coated with ultraviolet- and blue-blocking filters (400-440/440-500 nm)
- Subject diagnosed with severe sleep apnea; using the Sleep Apnea scale of the Sleep Disorders Questionnaire (SA-SDQ) the study will use a score of 29 as a cutoff for men and a cutoff of 26 for women
- Subject diagnosed with restless leg syndrome (RLS); using the International Restless Legs Scale (IRLS), the study will use a cutoff of ≥11 as a positive screen for RLS
- Subject has a history of severe photosensitivity dermatitis, severe progressive retinal disease (e.g., macular degeneration), or a permanently dilated pupil (e.g., after certain types of cataract surgery) For caregivers, we will accept those who:
- Live with the patients
- Are not diagnosed with dementia (MOCA between 25 and 30 and CDR=0)
- Understand English
- Are willing to help with the study
- No other inclusion/exclusion criteria will be used for enrolling caregivers. There is no age requirement for caregivers.
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Conditions:
- Alzheimer Disease
- Cognitive Dysfunction