Investigating the Impact of Duration and Amount of Light on the Circadian System Response - Aim 3

Not Applicable

Recruiting

• Conditions: Alzheimer's Disease; Mild Cognitive Impairment
• Interventions: Device: Active Lighting Intervention; Device: Control Lighting Intervention

• Registration Number: NCT06595030
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Investigate the long-term impact of amount and duration of Tailored Lighting Intervention (TLI) obtained from Aims 1 and 2 on sleep, cognition, circadian marker, mood, and behavior in AD/ADRD patients. For this single-arm, randomized, placebo-controlled study, the researchers plan to recruit 100 participants who will experience either the active TLI or the placebo for 6 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Study Start: 2024-12-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-12-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Lighting Intervention	Active Lighting Intervention	Combining spectrum and light level, the active TLI will allow the researchers to use a light source that will stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered.
Control Lighting Intervention	Control Lighting Intervention	The control TLI will allow the researchers to use a light source that will not stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered.

Primary Outcome Measures

Name	Time	Method
Change in Sleep Disturbance using the Pittsburgh Sleep Quality Index (PSQI)	Up to Week 36	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 full scale range of 0 to 21. A higher score indicates higher sleep disturbance.

Secondary Outcome Measures

Name	Time	Method
Sleep efficiency using actigraphy	Up to Week 36	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
Depression using the Cornell Scale for Depression in Dementia (CSDD)	Up to Week 36	The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. Full Scale ranges from 0 to 38 with a higher score indicating greater depression.
Light measurements using the Daysimeter	Up to Week 36	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.
Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)	Up to Week 36	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.
Cognitive status Using the Montreal Cognitive Assessment (MOCA)	Up to Week 36	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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States