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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01816152
Other study ID # GCO 20-4007
Secondary ID 7R01AG034157-11
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date May 10, 2024

Study information

Verified date June 2024
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date May 10, 2024
Est. primary completion date May 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Tailored Active intervention
Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.
Inactive intervention
Subjects experience a baseline for 1 week and an inactive intervention for 4 weeks. The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.

Locations

Country Name City State
United States Icahn School of Medicine at Mount Sinai Albany New York
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (2)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Figueiro MG, Hamner R, Higgins P, Hornick T, Rea MS. Field measurements of light exposures and circadian disruption in two populations of older adults. J Alzheimers Dis. 2012;31(4):711-5. doi: 10.3233/JAD-2012-120484. — View Citation

Figueiro MG, Plitnick BA, Lok A, Jones GE, Higgins P, Hornick TR, Rea MS. Tailored lighting intervention improves measures of sleep, depression, and agitation in persons with Alzheimer's disease and related dementia living in long-term care facilities. Cl — View Citation

Hanford N, Figueiro M. Light therapy and Alzheimer's disease and related dementia: past, present, and future. J Alzheimers Dis. 2013;33(4):913-22. doi: 10.3233/JAD-2012-121645. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep Disturbance 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 Change from Baseline (week 0) and intervention (week 4)
Primary Agitation 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 Change from Baseline (week 0) and intervention (week 4)
Primary Depression 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. Change from Baseline (week 0) and intervention (week 4)
Secondary Activity of Daily Living Caregivers and subjects are asked to fill out subjective Activity of Daily Living questionnaire (MDS-ADL), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. Scores range from 4 to 18 and a higher score indicates a higher dependence. Change from Baseline (week 0) and intervention (week 4)
Secondary Light/dark patterns Subjects are asked to wear a calibrated light meter to obtain light/dark and activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. These data are used to determine circadian disruption (correlation between light/dark and activity/rest) and light dose. Change from Baseline (week 0) and intervention (week 4)
Secondary Actigraphy Subjects are asked to wear an actigraph to obtain activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. Actigraphs are used to measure sleep efficiency. Change from Baseline (week 0) and intervention (week 4)
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