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

Alzheimer's Disease Clinical Trial

Official title:

A Study to Examine the Effect of Therapeutic Light on Sleep, Circadian Rhythm, and Global Function in Women With Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502045
• Other study ID #: 1310012895
• Status: Completed
• Phase: N/A
• First received: July 16, 2015
• Last updated: February 17, 2017
• Start date: May 2012
• Est. completion date: January 2016

Study information

• Verified date: February 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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
• Non-therapeutic Red Light
Non-therapeutic red light control at 5 lux will be used as the control condition

Locations

Country	Name	City	State
United States	Botsford Continuing Care	Farmington Hills	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep characteristics	Change in sleep characteristics and rest-activity rhythm after 2 weeks of light therapy as measured by actigraphy	2 weeks