The Long-term Impact of a Light Intervention on Sleep Physiology and Cognition in Mild Cognitive Impairment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 73
- Locations
- 3
- Primary Endpoint
- Cognition using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cognition using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
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.
Cognition using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
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.
Secondary Outcomes
- Depression using the Geriatric Depression Scale (GDS)(Will be administered at baseline and the end of weeks 9, 17, 25 and 37)
- Quality of Life using the Dementia Quality of Life Instrument (DQoL)(Will be administered at baseline and the end of weeks 9, 17, 25 and 37)
- Light Exposure measurement in MCI Participants(Will be worn for seven days during baseline and seven days during weeks 9, 17, 25 and 37)
- Sleep Efficiency in the MCI Participant(Will be worn for seven days during baseline and for seven days during weeks 9, 17, 25 and 37)
- Cognition using the Montreal Cognitive Assessment (MoCA) tool(Will be administered at baseline and the end of weeks 9, 17, 25 and 37)
- Cognition using the Word Pairs Associates (WPA) Task(Will be administered at baseline and the end of weeks 9, 17, 25 and 37)
- Sleep Quality in the MCI Participant using the Pittsburgh Sleep Quality Index (PSQI)(Will be administered at baseline and the end of weeks 9, 17, 25 and 37)
- Cognition using the Working Memory (WM) Task(Will be administered at baseline and the end of weeks 9,17, 25 and 37)
Investigators
Mariana Figueiro
Professor
Icahn School of Medicine at Mount Sinai