N/A
N=52
Rhythmic Light Therapy for Alzheimer's Disease Patients
Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT05015478 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) — 3.54; 5.28; 2.83; 4.10 μV2/Hz
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tailored Rhythmic Lighting Intervention (Device); Placebo Rhythmic Lighting Intervention (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) |
3.54; 5.28; 2.83; 4.10; 2.69; 5.24 | — |
| SECONDARY Mean Change in Subjective Sleepiness Using the Karolinska Sleepiness Scale (KSS) |
0.44; 0.49 | — |
| SECONDARY Cognition Using a Working Memory Task |
— | — |
Summary
The investigator will investigate how light delivering 40 hertz (Hz) affects subjective sleep and cognition in a controlled laboratory study. A lab study will allow the collection of electroencephalogram (EEG) data, perform cognitive tests, and observe the response in those with mild cognitive impairment (MCI) compared to a healthy control group (HC).
Participants will attend two study sessions over the course of two weeks. During both sessions, all participants will experience 10 minutes of a low-level light, followed by a data collection period which involves a sleepiness rating, an electroencephalogram (EEG) recording, and a computerized memory test. Participants will then experience either a RL or a placebo RL condition for one hour, after which there will be a second data collection.
Eligibility Criteria
Inclusion Criteria
- 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
- For the 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 score a 5 or less in the Pittsburgh Sleep Quality Index (PSQI)
Exclusion Criteria
- All participants must not be taking sleeping medication or oral melatonin
- Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
- residence in a skilled nursing facility or long-term care
- Major organ failure (e.g., kidney failure)
- Uncontrolled generalized disorders such as hypertension or diabetes
- Obstructing cataracts, macular degeneration, and blindness
- Severe sleep apnea or restless leg syndrome
- History of epilepsy
Data sourced from ClinicalTrials.gov (NCT05015478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.