N/A
N=118
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Sleep Initiation and Maintenance Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00946530 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Total Sleep Time — 393; 420; 398; 409 units on a scale (minutes)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bright light (Device); Control (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Sleep Time |
393; 420; 398; 409 | — |
| SECONDARY WASO (Wake After Sleep Onset) |
124; 107; 63.4; 61.0 | — |
Summary
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00946530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.