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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04073628
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Mariana G Figueiro, Rensselaer Polytechnic Institute

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer's Disease Device: Lighting Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Long-term Impact of a Light Intervention on Sleep Physiology and Cognition in Mild Cognitive Impairment
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Cognition using the Word Pairs Associates (WPA) Task [ 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 by the Word Pairs Associate (WPA) task, in which subjects are visually presented with word-nonsense word pairs, to maximize the novel episodic and associative declarative memory demands of the task and minimize the semantic demands of the task. Participants are presented with 48 word-pairs in the evening WPA task session. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval (24 hours later to avoid circadian confounds). For the test, participants are presented with 40 intact word pairs (leaving off the first and last four pairs to avoid primacy and recency effects), as well as 40 rearranged word pairs (foils). Each word pair is displayed for 3000 milliseconds followed by a response prompt asking for a discrimination of whether the two words were shown together as a pair in the study list.

  2. Cognition using the Working Memory (WM) Task [ 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 by the Working Memory (WM) task, comprised of nine practice and 20 test trials. Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct. Each of the simple math equation is on the screen for 3000 ms and each letter is presented for 1000 ms. Participants are instructed to press the "M" key with their right hand if the simple math equation is correct and press the "V" key with their left hand if the equation is not correct. Math performance is measured in percent correct. After each trial, a question mark appears on the screen to signal the response period. Participants are asked to enter the letters in the same order they were presented. Participants are tested in the WM task before a night of sleep and 24 hours later. Performance is assessed by calculating Accuracy and Reaction Time (RT).

  3. Cognition using Implicit Priming Task [ 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 a pictorial implicit priming task. Participants will be presented with simple pictures of objects and animals. Following a break, the participant will then be asked to identify a larger set of pictures, some of which were shown previously and some of which are new.

  4. 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.

  5. 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.

  6. Sleep Quality in the Caregiver 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 caregiver 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.

  7. Sleep Spindles using Ambulatory Electroencephalography (EEG) [ Time Frame: Will be administered once at baseline and once at the end of weeks 9, 17, 25 and 37 ]
    Change in character of sleep spindles of the MCI participant will be assessed by utilizing ambulatory electroencephalography. Participants' at-home sleep periods for one night of each assessment week will be recorded with electroencephalograph (EEG).

  8. Slow Oscillation Sleep Activity using Ambulatory Electroencephalography (EEG) [ Time Frame: Will be administered once at baseline and once at the end of weeks 9, 17, 25 and 37 ]
    Change in slow oscillation sleep activity of the MCI participant will be assessed by utilizing ambulatory electroencephalography. Participants' at-home sleep periods for one night of each assessment week will be recorded with electroencephalograph (EEG),

  9. Caregiver Burden using the Zarit Burden Interview (ZBI) [ Time Frame: Will be administered at baseline and the end of weeks 9, 17, 25 and 37 ]
    Change in caregiver burden will be assessed utilizing the Zarit Burden Interview (ZBI). The ZBI contains two subscales, one measuring psychological distress (Personal Strain, comprising 12 items) and the other measuring the impact of caregiving (Role Strain, comprising six items). Each question is scored on a 5-point Likert scale ranging from 'never' to 'nearly always present.' A lower score indicates lower burden.


Secondary Outcome Measures :
  1. Depression using the Geriatric Depression Scale (GDS) [ Time Frame: Will be administered at baseline and the end of weeks 9, 17, 25 and 37 ]
    Change in depression of the MCI participant will be assessed via the Geriatric Depression Scale (GDS). The GDS is an instrument used to measure depression in healthy adults. We will use a short version of the GDS consisting of 15 questions. Ten of the questions indicate the presence of depression when answered positively, and the other five questions indicate depression when answered negatively. A lower score indicates less depressive symptoms.

  2. Quality of Life using the Dementia Quality of Life Instrument (DQoL) [ Time Frame: Will be administered at baseline and the end of weeks 9, 17, 25 and 37 ]
    Change in quality of life of the MCI participant will be assessed with the Dementia Quality of Life Instrument (DQoL), via interview format. The DQoL measures self-esteem, positive affect/humor, negative affect, feelings of belonging, and sense of aesthetics. The DQoL consists of 29 items, grouped into five subscales according to domain. Subjects are instructed to answer using a 5-point response scale.

  3. Light Exposure measurement in MCI Participants [ Time Frame: Will be worn for seven days during baseline and seven days during weeks 9, 17, 25 and 37 ]
    MCI participants will be given a daysimeter and asked to wear it as a pendant during all times while awake over the course of seven days during assessment weeks. The daysimeter will be used to monitor the total amount of circadian light received by the participant during the intervention weeks.

  4. Light Exposure in Caregivers [ Time Frame: Will be worn for seven days during baseline and seven days during weeks 9, 17, 25 and 37 ]
    Caregivers will be given a daysimeter and asked to wear it as a pendant during all times while awake over the course of seven days during assessment weeks.

  5. Sleep Efficiency in the MCI Participant [ Time Frame: Will be worn for seven days during baseline and for seven days during weeks 9, 17, 25 and 37 ]
    MCI participants will be asked to wear an actigraph for seven days during the assessment weeks. A positive change in sleep efficiency is better.

  6. Sleep Efficiency in the Caregiver [ Time Frame: Will be worn for seven days during baseline and for seven days during weeks 9, 17, 25 and 37 ]
    Caregivers will be asked to wear an actigraph for seven days during the assessment weeks.

  7. Quality of Life using the Quality of Life in Alzheimer's Disease D - QOL-AD [ Time Frame: Will be administered at baseline and the end of weeks 9, 17, 25 and 37 ]
    Change in quality of life of the caregivers will be assessed via the Quality of Life AD (QOL_AD) instrument. The QOL-AD was designed to address aspects of quality of life that informal and formal caregivers and clinicians consider important.

  8. Cognition in the Caregiver using the Word Pairs Associates (WPA) Task [ Time Frame: Will be administered at baseline and the end of weeks 9, 17, 25 and 37 ]
    Cognitive change of the caregiver will be assessed by the Word Pairs Associate (WPA) task, in which subjects are visually presented with word-nonsense word pairs, to maximize the novel episodic and associative declarative memory demands of the task and minimize the semantic demands of the task. Participants are presented with 48 word-pairs in the evening WPA task session. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval (24 hours later to avoid circadian confounds).

  9. Cognition in the Caregiver using the Working Memory (WM) Task [ Time Frame: Will be administered at baseline and the end of weeks 9, 17, 25 and 37 ]
    Cognitive change of the caregiver will be assessed by the Working Memory (WM) task, comprised of nine practice and 20 test trials. Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct. Each of the simple math equation is on the screen for 3000 ms and each letter is presented for 1000 ms. Participants are instructed to press the "M" key with their right hand if the simple math equation is correct and press the "V" key with their left hand if the equation is not correct. Math performance is measured in percent correct. After each trial, a question mark appears on the screen to signal the response period. Participants are asked to enter the letters in the same order they were presented. Participants are tested in the WM task before a night of sleep and 24 hours later. Performance is assessed by calculating Accuracy and Reaction Time (RT).

  10. Cognition using the Montreal Cognitive Assessment (MoCA) tool [ 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 by utilization of the Montreal Cognitive Assessment (MoCA) tool. The MoCA is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. In a validation study, it was shown to be a promising tool for detecting mild cognitive impairment and early Alzheimer's disease onset compared to the Mini Mental State Exam.

  11. Cognition using the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) tool [ 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 obtained using the Clinical Dementia Rating Scale Sum of Boxes through semi-structured interviews where cognitive functioning will be rated in six domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR-SOB score is obtained by summing each of the domain box scores. The CDR-SOB demonstrates good reliability and has been validated against neuropathologic finding.

  12. Depression using the Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Will be administered at baseline and the end of weeks 9, 17, 25 and 37 ]
    Change in depression of the caregiver will be assessed with the Depression using the Center for Epidemiological Studies Depression Scale (CES-D). This 20-item test measures depressive symptoms, asking how often over the past week participants experienced symptoms associated with depression (restless sleep, poor appetite, feelings of loneliness). A lower score indicates a decrease in depressive symptoms.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073628


Contacts
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Contact: Barbara Plitnick, RN 518-276-7166 plitnb@rpi.edu
Contact: Mariana Figueiro, PhD 518-276-7142 figuem@rpi.edu

Locations
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United States, New York
Rensselaer Polytechnic Institute Recruiting
Troy, New York, United States, 12180
Contact: Barbara Plitnick, RN    518-276-7166    plitnb@rpi.edu   
Sponsors and Collaborators
Rensselaer Polytechnic Institute
Investigators
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Principal Investigator: Mariana Figueiro, PhD Renssalear Polytechnic Institute
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Responsible Party: Mariana G Figueiro, Professor, Rensselaer Polytechnic Institute
ClinicalTrials.gov Identifier: NCT04073628    
Other Study ID Numbers: AG062288
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mariana G Figueiro, Rensselaer Polytechnic Institute:
Mild Cognitive Impairment, sleep and memory
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders