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High Intensity Light Therapy in Alzheimer's Disease

Primary Purpose

Alzheimer's Disease, Dementia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

high-intensity light therapy

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, light therapy, long-term care, depression, sleep, agitation

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Diagnosis of dementia Residence on study units Exclusion criteria: Bipolar disorder Severe retinal (eye) disease

Sites / Locations

John Umstead Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00065689

First Posted

July 31, 2003

Last Updated

July 24, 2006

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00065689

Brief Title

High Intensity Light Therapy in Alzheimer's Disease

Official Title

High Intensity Light Therapy in Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2006

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief 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.

Detailed Description

See Brief Summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease, Dementia

Keywords

Alzheimer's disease, light therapy, long-term care, depression, sleep, agitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

107 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

high-intensity light therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Diagnosis of dementia Residence on study units Exclusion criteria: Bipolar disorder Severe retinal (eye) disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip D. Sloane, MD, MPH

Official's Role

Principal Investigator

Facility Information:

Facility Name

John Umstead Hospital

City

Butner

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

12. IPD Sharing Statement

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High Intensity Light Therapy in Alzheimer's Disease

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