Mild Cognitive ImpairmentNCT04073628
The Long-term Impact of a Light Intervention on Sleep and Cognition in Mild Cognitive Impairment
A study testing Lighting Intervention in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- Lighting Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Icahn School of Medicine at Mount Sinai
Albany, New York, 12204
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Being tested
- Lighting Intervention
- Keywords
- Mild Cognitive Impairment, sleep and memory
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lighting InterventionDevice
Lighting Intervention consisting of a cool or warm light source.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Lighting Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Will be administered at baseline and the end of weeks 9, 17, 25 and 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start14 Jun 2021
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mariana Figueiro, Icahn School of Medicine at Mount Sinai
- Investigators
- Mariana Figueiro, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073628
- Sponsor's protocol ID
- GCO 21-0019
- Other IDs
- R01AG062288
- Status last verified
- May 2026
- First submitted
- 27 Aug 2019
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Impact of a Light Intervention on Sleep Physiology and Cognition in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04073628
- Acronym / sponsor ID
- GCO 21-0019
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Keywords
- Mild Cognitive Impairment, sleep and memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Rutgers University, National Institute on Aging (NIA)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Lighting intervention | Active comparator | Device: Lighting InterventionThe 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 |
| Control Lighting Intervention | Placebo comparator | Device: Lighting InterventionThe control lighting intervention will consist of low levels of a warm light source designed not to impact the circadian system. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lighting InterventionLighting Intervention consisting of a cool or warm light source. | Device | Active Lighting intervention, Control Lighting Intervention |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Figueiro, PhD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lighting Intervention in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.