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Effect of Therapeutic Light on Sleep, Circadian Rhythm, and Global Function in Women With Alzheimer's

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ClinicalTrials.gov Identifier: NCT02502045
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
Determine effect and duration of effect of timed therapeutic light compared to control light on parameters of circadian rhythmicity, physiologic plasticity, sleep, and global function in women with Alzheimer's Disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Device: Morning Simulated Sunlight Device: Non-therapeutic Red Light Not Applicable

Detailed Description:
The impact of disturbed sleep on cognition and functional domains is vitally important to study in order to increase our understanding of Alzheimer's disease (AD) phenomenology. Research has shown that the severity of sleep disturbance and dementia advance in parallel and possibly in a manner amenable to therapeutic intervention. In AD, sleep disruption is characterized by changes in sleep architecture. It is our contention that neuropathology specific to AD alters the circadian system at the suprachiasmatic nucleus (SCN). Environmental light is the most powerful regulator of this circadian system,4,5 and is known to have a significant regulatory effect on pineal melatonin synthesis and secretion via the SCN and multisynaptic pathways downstream from the SCN. This study will explore further the efficacy of a particular type of therapeutic light intervention in regulating the circadian system in AD, using data analytic methods capable of detecting changes at multiple time scales. Our central hypothesis is that properly-timed light exposure in individuals with AD will synchronize disorganized circadian and sleep-wake rhythms and improve functional plasticity [approximate entropy (ApEn), fractal dimension (FD)], thereby resulting in increased sleep efficiency (SE), reductions in sleep fragmentation (SF), reduced excessive daytime sleepiness (EDS) and dementia-related behaviors, and improvements in cognition and other daytime behaviors. Women are nearly twice as likely as men to develop AD due to longer life expectance and emerging evidence. In light of this increased risk and also to enhance other aspects of biological uniformity in our study, this project will investigate women with AD.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Study to Examine the Effect of Therapeutic Light on Sleep, Circadian Rhythm, and Global Function in Women With Alzheimer's Disease
Study Start Date : May 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Morning Simulated Sunlight
Timed morning simulated sunlight (Philips Wake Up Light, Model HF3520) peaking at 300 lux delivered over a 40 minute ramp between 5-9 a.m. for 14 consecutive days. A flexible window of has been allowed to accommodate participants and care routines.
Device: Morning Simulated Sunlight
Timed morning simulated sunlight (Philips Wake Up Light, Model HF3520) peaking at 300 lux delivered over a 40 minute ramp between 5-9 a.m. for 14 consecutive days

Placebo Comparator: Non-Therapeutic Red Light
Non-therapeutic red light control at 5 lux will be used as the control condition
Device: Non-therapeutic Red Light
Non-therapeutic red light control at 5 lux will be used as the control condition




Primary Outcome Measures :
  1. Change in sleep characteristics [ Time Frame: 2 weeks ]
    Change in sleep characteristics and rest-activity rhythm after 2 weeks of light therapy as measured by actigraphy



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

Inclusion Criteria:

  1. baseline sleep efficiency index < .85
  2. Mini-Mental State Exam-2 Standard Version (MMSE-2:SV) score of 0-20
  3. be medically stable

Exclusion Criteria:

  1. received light treatment in last 3 months
  2. are totally blind in both eyes, have photosensitivity or photophobia, Parkinsons disease, known untreated sleep apnea or other sleep disorders, seizure disorder, bipolar, schizophrenia, are actively receiving chemotherapy or radiation therapy for cancer.

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): NCT02502045


Locations
United States, Michigan
Botsford Continuing Care
Farmington Hills, Michigan, United States, 48336
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: LuAnn Etcher, PhD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02502045     History of Changes
Other Study ID Numbers: 1310012895
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders