Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2

Alzheimer's Disease Clinical Trial

Official title:

Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837819
• Other study ID #: STUDY-20-01736
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Barbara Plitnick
• Phone: 518-242-4603
• Email: barbara.plitnick[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim 2 will investigate the effect of 3 different light exposure lengths on sleep, mood and agitation in persons with Alzheimer's disease. Participants will be randomly assigned to one of three conditions of light exposure: 1) 2-h morning light exposure; 2) 4-h morning light exposure; and 3) all day light exposure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score <25

• Sleep disturbance with a Pittsburgh Sleep Quality Index score =5

Exclusion Criteria:

• Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease

• Obstructing cataracts

• Severe macular degeneration

• Use of sleep medication

• Use of oral melatonin

• untreated moderate to severe sleep apnea

• Severe restless leg syndrome

• Blindness

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Device:
• Active Lighting Intervention
Lighting intervention using high light levels designed to effect the circadian system
• Control Lighting Intervention
Lighting intervention using low light levels designed to not effect the circadian system

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 (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Disturbance using the Pittsburgh Sleep Quality Index	The PSQI is used to measure sleep quality and is composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each subscale is scored 0 to 3. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A higher score indicates higher sleep disturbance	up to week 14
Secondary	Sleep efficiency using actigraphy	Actigraphs will be worn continuously for 7 days during each assessment week. Changes in sleep efficiency will be measured using the actigraphy software. Sleep efficiency is a calculated as a ratio of the time spent in bed and the time spent sleeping.	up to week 14
Secondary	Depression using the Cornell Scale for Depression in Dementia (CSDD)	The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. This tool evaluates the presence and extent of mood-related signs (anxiety, sadness, irritability), behavioral disturbances (agitation, loss of interest), physical signs (loss of appetite, weight loss), cyclic functions (mood variation, sleep quality), and ideational disturbances. Scores range from 0 to 38 with a higher score indicating greater depression.	up to week 14
Secondary	Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)	The CMAI assesses the frequency of manifestations of agitated behaviors in elderly persons. The CMAI is a caregivers' rating questionnaire consisting of 29 agitated behaviors, each rated on a 7-point scale of frequency. Score ranges from 30 to 210 with a higher score indicating higher agitated behavior.	up to week 14
Secondary	Light measurements using the Daysimeter	Circadian light measurements will be collected during waking hours for 7 days each assessment week using the daysimeter. The light measurement is reported as Lux levels.	up to week 14
Secondary	Cognitive status Using the Montreal Cognitive Assessment (MOCA)	The MoCA is a 1-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. Total score range from 0 to 30. Lower score indicates lower cognitive status.	up to week 14