We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Light and the Effect on Metabolic Syndrome and Alzheimer's Disease

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: NCT03777722
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : April 25, 2022
Sponsor:
Collaborator:
Rutgers University
Information provided by (Responsible Party):
Mariana Figueiro, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE December 17, 2018
Last Update Posted Date April 25, 2022
Actual Study Start Date  ICMJE November 19, 2018
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Change in Glucose tolerance [ Time Frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26 ]
    change in glucose tolerance from baseline will be assessed using an oral glucose tolerance test
  • Change in sleep disturbance [ Time Frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26 ]
    Change in sleep disturbance will be assessed using the Pittsburgh Sleep Quality Index. The sum of the 7 component scores yields a single global score. A person with a global score above 5 is considered to have sleep disturbances. A higher score indicates worsening sleep disturbance.
  • Change in depression [ Time Frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26 ]
    A change in depression will be assessed using the Cornell Scale for Depression in Dementia. A score of twelve or more points indicates depression. A higher score indicates worsening depression.
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
  • Change in Glucose tolerance [ Time Frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26 ]
    change in glucose tolerance from baseline will be assessed using an oral glucose tolerance test
  • change in depression [ Time Frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26 ]
    A change in depression will be assessed using the Cornell Scale for Depression in Dementia. A score of nine or more points indicates depression.
  • Change in sleep disturbance [ Time Frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26 ]
    Change in sleep disturbance will be assessed using the Pittsburgh Sleep Quality Index. The sum of the 7 component scores yields a single global score. A person with a global score above 5 is considered to have sleep disturbances.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Sleep Efficiency using actigraphy [ Time Frame: 7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26 ]
    Actigraphs will be worn for 7 days during assessment weeks. Actigraphy will be used to calculate changes in sleep efficiency. A higher sleep efficiency indicates better sleep.
  • Light exposure using the Daysimeter [ Time Frame: 7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26 ]
    Daysimeters will be worn for 7 days during assessment periods to measure the amount of circadian effective light delivered by the lighting intervention.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Light and the Effect on Metabolic Syndrome and Alzheimer's Disease
Official Title  ICMJE Light, Metabolic Syndrome and Alzheimer's Disease: A Non-Pharmocological Approach
Brief Summary This study's main hypothesis is that a delivering a tailored lighting intervention (TLI) will provide a successful means for promoting circadian entrainment and treating metabolic disease and inflammation in patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD) and Alzheimer's disease and related dementias (ADRD). As such, the proposed studies have the potential to provide important insights into the link between AD/ADRD and type 2 diabetes (T2DM) by identifying the disruption of circadian rhythms as a key component in the metabolic impairment. Preliminary data from ongoing studies demonstrates a beneficial effect of light treatment on sleep and depression. If positive results are observed, the potential also exists to transform the manner in which homes, assisted living facilities, and nursing homes are lighted by delivering a simple, practical, non-pharmacological intervention to promote entrainment, improve sleep, and reduce metabolic disease in AD and mild AD MCI patients. This randomized, placebo-controlled, crossover study involving 60 AD/ADRD patients who live in controlled environments (i.e., assisted living facilities and nursing homes), will investigate whether 8 weeks of exposure to a TLI designed to increase circadian entrainment improves sleep, mood, inflammatory markers, and metabolic control, compared to a control, circadian-inactive light.
Detailed Description

Alzheimer's disease (AD) and type 2 diabetes (T2DM) pose linked, major threats to aging societies worldwide, but the relationship between these two diseases remains poorly understood. Hence, insulin resistance may account for the close epidemiological association between AD and T2DM. A major gap in the understanding of this association, however, is how brain insulin resistance develops in the context of AD. Studies show that circadian disruption impairs metabolic control and increases the risk for diabetes and obesity. Vice versa, disrupted sleep and depression are closely linked to impaired metabolic control and increased diabetes risk in the general population. Notably, AD is associated with circadian disruption, which may be amplified by exposure to irregular light-dark patterns or constant dim light. To what extent circadian disruption contributes to increased diabetes risk in AD remains unclear. Here, the investigator aims to test whether a novel tailored lighting intervention (TLI) designed to promote circadian entrainment in AD patients can improve metabolic control. Preliminary data from ongoing studies demonstrates a beneficial effect of light treatment on sleep and depression. Given the close association of sleep on metabolic control, these data support the hypothesis that light therapy that promotes entrainment can restore metabolic control in AD patients. Specifically, the investigator will test the efficacy of a practical, scientifically sophisticated 24-hour lighting system for increasing circadian entrainment in older adults with AD and related dementias (ADRD). The major goal is to demonstrate that a practical, effective, tailored, nonpharmacological intervention that promotes circadian entrainment can be used to improve sleep, reduce inflammation, and ameliorate glucose intolerance and insulin resistance in AD/ADRD patients.

Aim 1: Test if a TLI that promotes entrainment can improve sleep, depression, inflammation, and glucose tolerance in patients with moderate to late stages ADRD. In a randomized, placebo-controlled, crossover study involving 60 ADRD patients who live in controlled environments, the investigators will investigate whether an 8-week exposure to a TLI designed to increase circadian entrainment (urinary melatonin and activity-rest patterns) will improve inflammation and glucose tolerance (oral glucose tolerance test), and reduce sleep disturbances (actigraphy, Pittsburgh Sleep Quality Index, PSQI) and depressive symptoms (Cornell Scale for Depression in Dementia, CSDD) compared to a control, circadian-inactive light.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Crossover placebo controlled design
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer Disease
  • Diabetes Mellitus, Type 2
Intervention  ICMJE Device: Tailored Lighting Intervention
Lighting Intervention - active or placebo
Study Arms  ICMJE
  • Experimental: Aim 1: Active Intervention then Placebo
    Tailored Lighting intervention (TLI). The active TLI 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. The active lighting intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the placebo control intervention for 8 weeks.
    Intervention: Device: Tailored Lighting Intervention
  • Experimental: Aim 1: Placebo Intervention then Active
    The placebo lighting intervention is designed to have no effect on the circadian system. The control intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the active tailored lighting intervention for 8 weeks.
    Intervention: Device: Tailored Lighting Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2023
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of mild to moderate Alzheimer's disease or related dementia,
  • type 2 diabetes
  • sleep disturbance as determined by a score ≥ 5 on the PSQI

Exclusion Criteria:

  • insulin-dependent diabetes,
  • urinary incontinence
  • obstructing cataracts
  • macular degeneration
  • blindness
  • severe sleep apnea or
  • restless leg syndrome (RLS)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barbara Plitnick, BSN 518-276-7142 barbara.plitnick@mountsinai.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03777722
Other Study ID Numbers  ICMJE GCO 17-2685
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mariana Figueiro, Icahn School of Medicine at Mount Sinai
Original Responsible Party Mariana G Figueiro, Rensselaer Polytechnic Institute, Professor
Current Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Original Study Sponsor  ICMJE Rensselaer Polytechnic Institute
Collaborators  ICMJE Rutgers University
Investigators  ICMJE
Principal Investigator: Mariana Figueiro, PhD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP