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Behavioural Intervention
Rhythmic Light Therapy for Alzheimer's Disease
N/A
Waitlist Available
Led By Mariana Figueiro, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For age-matched healthy controls, participants must not be diagnosed with mild cognitive impairment or Alzheimer's disease related dementias (MoCA score above 25)
Participants must be diagnosed with amnestic mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment (MoCA) score between 17 and 25
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour after intervention
Awards & highlights
Study Summary
This trial will investigate the effects of a red light emitting at 40 Hz on subjective sleep and cognition in people with mild cognitive impairment and a healthy control group.
Who is the study for?
This trial is for adults with mild Alzheimer's or cognitive impairment, scoring 17-25 on the MoCA test and 5 or less on the PSQI sleep quality index. It excludes those taking sleep meds, with other brain diseases, major organ failure, uncontrolled disorders like hypertension/diabetes, severe eye conditions, and certain sleep disorders.Check my eligibility
What is being tested?
The study tests if a special light therapy (40 Hz) improves sleep and cognition in people with mild cognitive issues compared to healthy controls. Participants will undergo two sessions involving exposure to this light followed by memory tests and EEG recordings over two weeks.See study design
What are the potential side effects?
Potential side effects are not explicitly mentioned but may include discomfort from bright lights or fatigue due to testing procedures. The EEG recording is generally safe but can cause minor skin irritation where electrodes are placed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am healthy, without signs of memory loss or dementia (MoCA score >25).
Select...
I have mild memory loss or mild Alzheimer's with a MoCA score between 17 and 25.
Select...
My sleep quality score is 5 or less.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour after intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electroencephalography
Secondary outcome measures
Cognition using a working memory task
Subjective Sleepiness using the Karolinska Sleepiness Scale (KSS)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Tailored Rhythmic LightingActive Control1 Intervention
1 hour intervention period where active lighting is experienced by participants.
Group II: Inactive Placebo Rhythmic LightingPlacebo Group1 Intervention
1 hour intervention period where an inactive, placebo lighting condition is experienced by participants.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,234 Total Patients Enrolled
Mariana Figueiro, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
9 Previous Clinical Trials
742 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of epilepsy.My dementia is not caused by another brain disease like Parkinson's or MS.I do not have major organ failure.My diabetes or high blood pressure is not under control.I am healthy, without signs of memory loss or dementia (MoCA score >25).I have mild memory loss or mild Alzheimer's with a MoCA score between 17 and 25.I have severe sleep apnea or restless leg syndrome.I am not taking any sleeping pills or oral melatonin.My sleep quality score is 5 or less.I do not have severe eye conditions like obstructing cataracts, macular degeneration, or blindness.
Research Study Groups:
This trial has the following groups:- Group 1: Inactive Placebo Rhythmic Lighting
- Group 2: Active Tailored Rhythmic Lighting
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it still possible to join this medical trial?
"According to clinicaltrials.gov, this medical study is actively searching for new participants; the trial was initially posted on January 10th 2022 and amended most recently on July 13th 2022."
Answered by AI
How many individuals are participating in this clinical experiment?
"Affirmative. Clinicaltrials.gov attests that this clinical trial, which was published on January 10th 2022, is currently recruiting participants. 40 patients at two separate sites are needed to complete the study."
Answered by AI
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