Phase 1 Methodology Issues in a Tailored Light Treatment for Persons With Dementia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Disturbances
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Sleep Disturbance
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia
Detailed Description
In a within subjects, randomized placebo control study, a tailored light treatment will be used for short-term (4 weeks). Outcome measures include sleep measures (actigraphy), and questionnaires probing behavior and mood in those who have been diagnosed with Alzheimer's disease and related dementia. After a 4-week washout period, a placebo control inactive light will be used for another 4 weeks.
Investigators
Mariana Figueiro
Professor, Population Health Science and Policy
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- •mild to moderate Alzheimer's disease and related dementia (ADRD)
Exclusion Criteria
- •major organ failure,
- •major illness,
- •history of head injury,
- •hypertension or diabetes,
- •use psychotropic (sleep aid) medicine, obstructing cataracts, macular degeneration, and blindness
Outcomes
Primary Outcomes
Sleep Disturbance
Time Frame: Change from Baseline (week 0) and intervention (week 4)
Caregivers and subjects are asked to complete the Pittsburgh Sleep Quality Index (PSQI), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The seven component scores are summed to provide a global score ranging from 0 to 21 and a score of 5 or above indicates sleep disturbance. A higher number indications a greater sleep disturbance
Depression
Time Frame: Change from Baseline (week 0) and intervention (week 4)
Caregivers and subjects are asked to fill out subjective questionnaires assessing depression using the Cornell Scale for Depression in Dementia (CSDD) Questionnaires are assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The CSDD consists of 19 questions rated on a scale of 0 to 2 with all scores summed for a total score. A score greater than 12 indicates depression and a higher score indicates greater depression.
Agitation
Time Frame: Change from Baseline (week 0) and intervention (week 4)
Caregivers and subjects are asked to fill out the Cohen-Mansfield Agitation Score, which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. All scores are summed for one total score - a higher score indicates more agitation
Secondary Outcomes
- Activity of Daily Living(Change from Baseline (week 0) and intervention (week 4))
- Light/dark patterns(Change from Baseline (week 0) and intervention (week 4))
- Actigraphy(Change from Baseline (week 0) and intervention (week 4))