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NCT Number: NCT04073628

The Long-term Impact of a Light Intervention on Sleep 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lighting Intervention

Device

Lighting Intervention consisting of a cool or warm light source.

Primary outcomes

  1. 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

  1. Sleep Quality in the MCI Participant using the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Will be administered at baseline and the end of weeks 9, 17, 25 and 37

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute on Aging (NIA)
  • Rutgers University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2019
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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