The Long-term Impact of a Light Intervention on Sleep and Cognition in Mild Cognitive Impairment (NCT04073628) | Clinical Trial Compass
CompletedNot Applicable
The Long-term Impact of a Light Intervention on Sleep and Cognition in Mild Cognitive Impairment
United States73 participantsStarted 2021-06-14
Plain-language summary
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.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for MCI/Mild AD Participant:
* 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 …
What they're measuring
1
Cognition using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
Timeframe: Will be administered at baseline and the end of weeks 9, 17, 25 and 37