Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 3
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:
• 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
Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
Menands
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Barbara Plitnick, BSN
Barbara.Plitnick@mountsinai.org
518-242-4603
Backup
Mariana Figueiro, PhD
mariana.figueiro@mountsinai.org
212-241-6500
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 100
Treatments
Active_comparator: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: Icahn School of Medicine at Mount Sinai