Investigating how light affects sleep and cognition in Alzheimer's patients
Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 3
This study is testing if a special lighting treatment can help improve sleep and thinking skills in people with Alzheimer's disease who have trouble sleeping.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 2 sites (Menands, New York and 1 other locations) |
| Trial ID | NCT06595030 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the long-term effects of a tailored lighting intervention on sleep, cognition, circadian markers, mood, and behavior in patients with Alzheimer's disease and related dementias. It is a single-arm, randomized, placebo-controlled trial involving 100 participants who will receive either the active lighting intervention or a placebo for a duration of six months. The study focuses on patients diagnosed with Alzheimer's or mild cognitive impairment who also experience sleep disturbances.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Alzheimer's disease or related dementia who have sleep disturbances.
Not a fit: Patients with extensive brain vascular disease, traumatic brain injury, or those using sleep medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve sleep quality and cognitive function in patients with Alzheimer's disease.
How similar studies have performed: Other studies have shown promising results with light interventions in improving sleep and cognitive function, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Menands, New York and 1 other locations
- Icahn School of Medicine at Mount Sinai — Menands, New York, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mariana Figueiro, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Barbara Plitnick, BSN
- Email: Barbara.Plitnick@mountsinai.org
- Phone: 518-242-4603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.