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

Not Applicable

Completed

• Conditions: Alzheimer's Disease
• Interventions: Device: Non-therapeutic Red Light; Device: Morning Simulated Sunlight

• Registration Number: NCT02502045
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-17
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Therapeutic Red Light	Non-therapeutic Red Light	Non-therapeutic red light control at 5 lux will be used as the control condition
Morning Simulated Sunlight	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.

Primary Outcome Measures

Name	Time	Method
Change in sleep characteristics	2 weeks	Change in sleep characteristics and rest-activity rhythm after 2 weeks of light therapy as measured by actigraphy

Trial Locations

Locations (1)

Botsford Continuing Care; 🇺🇸 Farmington Hills, Michigan, United States