The Long-term Impact of a Light Intervention on Sleep and Cognition in Mild Cognitive Impairment

Mount Sinai Health System

Status

Completed

Conditions

Alzheimer's Disease

Mild Cognitive Impairment

Treatments

Device: Lighting Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04073628

R01AG062288 (U.S. NIH Grant/Contract)

GCO 21-0019

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

73 participants in 2 patient groups, including a placebo group

Active Lighting intervention

Active Comparator group

Description:

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

Treatment:

Device: Lighting Intervention

Control Lighting Intervention

Placebo Comparator group

Description:

The control lighting intervention will consist of low levels of a warm light source designed not to impact the circadian system.

Treatment:

Device: Lighting Intervention