Methodology Issues in a Tailored Light Treatment for Persons With Dementia

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

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

Study Overview

• Status: Recruiting
• Conditions: Depression; Sleep Disturbances
• Intervention / Treatment: Other: Tailored Active intervention; Other: Inactive intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana G Figueiro, PhD; Phone Number: 518 3669306; Email: mariana.figueiro@mountsinai.org

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12204
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Mariana G Figueiro, PhD
      • Contact: Barbara Plitnick, BSN; Phone Number: 518-242-4603; Email: Barbara.Plitnick@mountsinai.org
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Barbara Plitnick, BSN; Phone Number: 212-659-9693; Email: barbara.plitnick@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Intervention; Light levels, primary and secondary measurements are obtained after a 4-week intervention period where active lighting is experienced by patients.	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.
Placebo Comparator: Inactive intervention; Light levels, primary and secondary measurements are obtained after a 4-week intervention period where an inactive lighting is experienced by patients	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Mariana G Figueiro, PhD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Clin Interv Aging. 2014 Sep 12;9:1527-37. doi: 10.2147/CIA.S68557. eCollection 2014.
• Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. J Clin Sleep Med. 2019 Dec 15;15(12):1757-1767. doi: 10.5664/jcsm.8078. Epub 2019 Nov 8.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 15, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimated): March 22, 2013

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: sleep; depression; agitation; circadian rhythms; light treatment
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Neurocognitive Disorders; Depression; Dyssomnias; Parasomnias; Dementia
• Other Study ID Numbers: GCO 20-4007; 7R01AG034157-11 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No