Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease

Stanford University

Status: Completed

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Device: Control; Device: Bright light

Study type: Interventional

Funder types: Other

Identifiers

NCT00946530

SU-06302009-2840

1677 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to demonstrate the efficacy of timed exposure to bright light for the treatment of disturbed nighttime sleep and daytime wake in community-dwelling dementia patients and their caregivers, and to determine if there are genetic relationships between memory problems and sleep problems

Full description

1. Efficacy: Up to 4 weeks of morning bright light exposure will be more efficacious than morning dim light in consolidating nighttime sleep as assessed by actigraphy.
2. Predictors of response: We expect the primary predictor of treatment response will be initial MMSE score. Secondary predictors include baseline sleep/wake and circadian parameters and age.
3. Effectiveness: Bright light treatment will be more effective than dim light in improving quality of life.
4. An understanding of some of the genetic markers of memory and/or sleep problems.

Enrollment: 118 patients

Sex: All

Ages: 55 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Alzheimer's Disease Patients:

• Stanford Alzheimer's Disease Core Center member or potential member, with diagnostic criteria met for probable AD, living with caregiver willing to participate in the protocol
• Non-institutionalized

Caregivers:

• Living in home of AD patient and willing to participate in protocol Exclusion Criteria:Alzheimer's Disease Patients:
• History of manic or bipolar disorder
• Prior bright light treatment
• Irregular or non-24 hour sleep/wake cycle
• Positive result on multi-staged RLS/PLMD
• Medical/Ophthalmologic Exclusions
• RDI >20 on overnight EdenTrace® recording

Caregivers:

• History of manic or bipolar disorder
• Medical/Ophthalmologic Exclusions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

118 participants in 2 patient groups, including a placebo group

Bright Light

Experimental group

Description:

received bright light

Treatment:

Device: Bright light

Control

Placebo Comparator group

Description:

received regular light

Treatment:

Device: Control