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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00065689
Other study ID # R01AT000212-01A1
Secondary ID SloaneP
Status Completed
Phase Phase 3
First received July 31, 2003
Last updated July 24, 2006
Start date March 2003
Est. completion date September 2005

Study information

Verified date July 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether bright light improves the sleep, mood, and behavior of persons with Alzheimer's disease and related dementias (AD) who live in long-term care settings and, if so, to determine the best timing for the light therapy. The light levels being used in the study have been shown to improve depression in persons with seasonal affective disorder (SAD) and to relieve sleep problems in persons with jet lag and other body rhythm disturbances. Because persons with AD often will not remain still in front of a fluorescent panel, this project has involved renovations in the study units that provide for even, regulated, high-intensity light in all public areas of the study settings.


Description:

See Brief Summary


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility Inclusion criteria:

- Diagnosis of dementia

- Residence on study units

Exclusion criteria:

- Bipolar disorder

- Severe retinal (eye) disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
high-intensity light therapy


Locations

Country Name City State
United States John Umstead Hospital Butner North Carolina

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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