Effect of Bright Light Treatment On Elders In a Long Term Care Environment

NCT ID: NCT01042587

Last Updated: 2010-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-06-30

Brief Summary

The investigators hypothesize that significant exposure to artificial morning bright light (approximately 200 lux of primarily blue light at eye level for thirty minutes daily) as compared to sham bright red light (placebo) will:

1. improve sleep quality

2. improve cognitive scores

3. improve depression scores

4. improve quality of life scores.

Detailed Description

Bright light therapy has been shown to improve depression and insomnia in multiple studies. These are common conditions among elders, particularly those residing in long term care environments. Bright light therapy has been inadequately studied in the geriatric population. We will show that a groups of twenty elders can simultaneous be exposed to bright light and that it will result in improvements in multiple realms of behavior and quality of life. Elders will be tested with a number of neuropsychological test batteries prior to exposure to bright light and again at the end of a four week exposure. Some subjects will have daytime and night time activity levels monitored with actigraphy. Cortisol and melatonin levels will be obtained prior to and at the end of the exposure period.

Conditions

Behavioral Responses to Bright Light Therapy in Elders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

bright light

Bright light has been shown to entrain circadian rhythm so our treatment arm will use thirty minutes of early morning exposure to bright blue light for a four week period.

Group Type: ACTIVE_COMPARATOR

exposure to bright light

Intervention Type: OTHER

Elders will be engaged in an activity period which will focus their attention in the direction of bright light, thus ensuring viewing the light source for a daily exposure of thirty minutes.

red light

Low level red light is a weak entrainment stimulus of circadian rhythm. Elders in the control group will be exposed to low level red light as a placebo for thirty minutes daily for four weeks.

Group Type: SHAM_COMPARATOR

low luminosity red light

Intervention Type: OTHER

Low level red light should not entrain circadian rhythm and will serve as a placebo control

Interventions

exposure to bright light

Elders will be engaged in an activity period which will focus their attention in the direction of bright light, thus ensuring viewing the light source for a daily exposure of thirty minutes.

Intervention Type: OTHER

low luminosity red light

Low level red light should not entrain circadian rhythm and will serve as a placebo control

Intervention Type: OTHER

Other Intervention Names

modified commercially available Phillips Color Graze.; modified commercially available Phillips Color Graze

Eligibility Criteria

Inclusion Criteria

• residents in Masonic Villages, Elizabethtown, PA long term care
• ability to give informed consent and complete the neuropsychological tests

Exclusion Criteria

• blindness
• severe illness expected to preclude the ability to complete treatment
• moderate to severe dementia that precludes the ability to complete testing
• light sensitivity making treatment to light therapy uncomfortable

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Penn State Milton S. Hershey Medical Center

Principal Investigators

Noel H Ballentine, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Masonic Villages

Elizabethtown, Pennsylvania, United States

Countries

United States

Other Identifiers

32704

Identifier Type: -

Identifier Source: org_study_id