Effect of Therapeutic Light on Sleep, Circadian Rhythm, and Global Function in Women With Alzheimer's
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morning Simulated Sunlight
Non-therapeutic Red Light
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- baseline sleep efficiency index < .85
- Mini-Mental State Exam-2 Standard Version (MMSE-2:SV) score of 0-20
- be medically stable
Exclusion Criteria:
- received light treatment in last 3 months
- 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.
Sites / Locations
- Botsford Continuing Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Morning Simulated Sunlight
Non-Therapeutic Red Light
Arm Description
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.
Non-therapeutic red light control at 5 lux will be used as the control condition
Outcomes
Primary Outcome Measures
Change in sleep characteristics
Change in sleep characteristics and rest-activity rhythm after 2 weeks of light therapy as measured by actigraphy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02502045
Brief Title
Effect of Therapeutic Light on Sleep, Circadian Rhythm, and Global Function in Women With Alzheimer's
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morning Simulated Sunlight
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Therapeutic Red Light
Arm Type
Placebo Comparator
Arm Description
Non-therapeutic red light control at 5 lux will be used as the control condition
Intervention Type
Device
Intervention Name(s)
Morning Simulated Sunlight
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Non-therapeutic Red Light
Intervention Description
Non-therapeutic red light control at 5 lux will be used as the control condition
Primary Outcome Measure Information:
Title
Change in sleep characteristics
Description
Change in sleep characteristics and rest-activity rhythm after 2 weeks of light therapy as measured by actigraphy
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
baseline sleep efficiency index < .85
Mini-Mental State Exam-2 Standard Version (MMSE-2:SV) score of 0-20
be medically stable
Exclusion Criteria:
received light treatment in last 3 months
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LuAnn Etcher, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Botsford Continuing Care
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Therapeutic Light on Sleep, Circadian Rhythm, and Global Function in Women With Alzheimer's
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