NCT04073628Completed
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
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 73 (actual)
- First submitted
- 27 Aug 2019
- Start date
- 14 Jun 2021
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Alzheimer disease
- NCT number
- NCT04073628
What you commit to
- Study type: Interventional
- Participants enrolled: 73
- From 14 Jun 2021 to the primary completion date, 30 Apr 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject has undergone cataract surgery and received an intraocular lens coated with ultraviolet- and blue-blocking filters (400-440/440-500 nm)
Other illness
- 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 has major organ failure (e.g., kidney failure)
- Subject has uncontrolled generalized disorders such as hypertension or diabetes
- 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:
- Are not diagnosed with dementia (MOCA between 25 and 30 and CDR=0)
Age
- No other inclusion/exclusion criteria will be used for enrolling caregivers. There is no age requirement for caregivers.
Other
- Subject resides in a skilled nursing facility or long-term care
- Subject has had recent changes in psychotropics (14 days)
- Subject has obstructing cataracts, macular degeneration, and/or blindness
- Live with the patients
- Understand English
- Are willing to help with the study
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.