Effect of Therapeutic Light on Sleep, Circadian Rhythm, and Global Function in Women With Alzheimer's
A Study to Examine the Effect of Therapeutic Light on Sleep, Circadian Rhythm, and Global Function in Women With Alzheimer's Disease
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 16, 2015
CompletedFirst Posted
Study publicly available on registry
July 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFebruary 20, 2017
February 1, 2017
3.7 years
July 16, 2015
February 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in sleep characteristics
Change in sleep characteristics and rest-activity rhythm after 2 weeks of light therapy as measured by actigraphy
2 weeks
Study Arms (2)
Morning Simulated Sunlight
EXPERIMENTALTimed 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
PLACEBO COMPARATORNon-therapeutic red light control at 5 lux will be used as the control condition
Interventions
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
Non-therapeutic red light control at 5 lux will be used as the control condition
Eligibility Criteria
You may qualify if:
- baseline sleep efficiency index \< .85
- Mini-Mental State Exam-2 Standard Version (MMSE-2:SV) score of 0-20
- be medically stable
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Botsford Continuing Care
Farmington Hills, Michigan, 48336, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
LuAnn Etcher, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2015
First Posted
July 17, 2015
Study Start
May 1, 2012
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
February 20, 2017
Record last verified: 2017-02