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

NCT04073628 | Completed

• 2 other identifiers: GCO 21-0019R01AG062288
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Keywords

Mild Cognitive Impairment, sleep and memory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Active Lighting intervention

ACTIVE COMPARATOR

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

Control Lighting Intervention

PLACEBO COMPARATOR

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

Device: Lighting Intervention

Interventions

Lighting Intervention DEVICE

Lighting Intervention consisting of a cool or warm light source.

Active Lighting intervention; Control Lighting Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Rutgers University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Icahn School of Medicine at Mount Sinai

Albany, New York, 12204, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Mariana Figueiro, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: In a single-arm, randomized, placebo-controlled (non-active comparison lighting intervention), between-subjects study, we will investigate the effect of long-term exposure (6 months) to a lighting intervention, which is designed to promote circadian entrainment.

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: June 14, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)