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

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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Alzheimer's Disease
• Intervention / Treatment: Device: Lighting Intervention

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12204
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Lighting intervention; 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	Device: Lighting Intervention; Lighting Intervention consisting of a cool or warm light source.
Placebo Comparator: Control Lighting Intervention; The control lighting intervention will consist of low levels of a warm light source designed not to impact the circadian system.	Device: Lighting Intervention; Lighting Intervention consisting of a cool or warm light source.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)	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.	Will be administered at baseline and the end of weeks 9, 17, 25 and 37

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality in the MCI Participant using the Pittsburgh Sleep Quality Index (PSQI)	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.	Will be administered at baseline and the end of weeks 9, 17, 25 and 37

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Aging (NIA); Rutgers University
• Investigators: Principal Investigator: Mariana Figueiro, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment, sleep and memory
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease
• Other Study ID Numbers: GCO 21-0019; R01AG062288 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No