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

NCT01042587 | Completed

• 1 other identifier: 32704
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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. 1.improve sleep quality
2. 2.improve cognitive scores
3. 3.improve depression scores
4. 4.improve quality of life scores.

Conditions

Behavioral Responses to Bright Light Therapy in Elders

Keywords

bright light therapy; circadian rhythm,; entrainment

Outcome Measures

Primary Outcomes (7)

• assessment of cognitive functioning using MicroCog

  once prior to intervention, once near the end of intervention, once four weeks after intervention

• Assessment of mood using the Geriatric Depression Scale

  once prior to intervention, once near the end of intervention, once four weeks after intervention

• assessment of quality of life using the SF-36

  once prior to intervention, once near the end of intervention, once four weeks after intervention

• assessment of sleep quality using the Pittsburgh Sleep Quality Index

  once prior to intervention, once near the end of intervention, once four weeks after intervention

• assessment of mood using the Profile of Moods Survey

  weekly throughout the duration of the study

• assessment of sleep quality using the Epworth Sleepiness Scale

  weekly throughout the duration of the study

• day and nightime activity level (5 subjects per group only) using Actigraphy

  two weeks prior to light exposure and the second two weeks during light exposure (continuous measurements)

Secondary Outcomes (2)

• salivary melatonin levels

  once prior and near the end of light exposure period

• salivary cortisol levels

  once prior and near the end of light exposure period

Study Arms (2)

bright light

ACTIVE COMPARATOR

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.

Other: exposure to bright light

red light

SHAM COMPARATOR

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.

Other: low luminosity red light

Interventions

exposure to bright light 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.

Also known as: modified commercially available Phillips Color Graze.

bright light

low luminosity red light OTHER

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

Also known as: modified commercially available Phillips Color Graze

red light

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Masonic Villages

Elizabethtown, Pennsylvania, 17022, United States

Location

Study Officials

• Noel H Ballentine, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 11, 2010

Record last verified: 2010-03

Locations

US (1)