Methodology Issues in a Tailored Light Treatment for Persons With Dementia

Depression Clinical Trial

Official title:

Phase 1 Methodology Issues in a Tailored Light Treatment for Persons With Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01816152
• Other study ID #: GCO 20-4007
• Secondary ID: 7R01AG034157-11
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Mariana G Figueiro, PhD
• Phone: 518 3669306
• Email: mariana.figueiro[@]mountsinai.org
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• 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

Related Conditions & MeSH terms

• Dementia
• Depression
• Dyssomnias
• Parasomnias
• Sleep Disturbances

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)