Mild Cognitive Impairment
Conditions
Keywords
Light Treatment, Circadian Rhythms, Gamma Wave Entrainment, Rhythmic Light, Mild Alzheimer's Disease, Sleep, Memory, Electroencephalogram
Brief 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.
Detailed description
The investigator will demonstrate the effect of 40 hertz (Hz) rhythmic light (RL) to promote gamma wave entrainment (rhythmic light \[RL\]) on: brain response (electroencephalography \[EEG\]); cognitive performance (working memory task); and subjective sleepiness (questionnaires). The study will recruit 20 adult mild cognitive impairment (MCI) patients and 20 healthy, age-matched controls (HC) to participate in this study. Sessions will initiate with a 10-minute adaptation period to a low-level ambient light providing illuminance of 15 lux at participants' eye level on a vertical plane, followed by a pre-exposure data collection period, including Karolinska Sleepiness Scale (KSS), EEG, and a working memory task. Participants will experience either 40 Hz RL or placebo RL conditions for a duration of 1 hour, followed by the second data collection period. On the second data collection day, participants will experience the other condition, so that all participants experience both lighting conditions. The experimental sessions will start at 14:00 on each experimental day which will be separated by 1 week.
Interventions
DEVICETailored Rhythmic Lighting Intervention
40 hertz (Hz) rhythmic lighting (RL) for a duration of 1 hour. The flicker frequency of the 40 Hz RL will be 40 Hz and the stimulation will be a square wave with a 50 % duty cycle (i.e., 12.5 milliseconds light- on and 12.5 milliseconds light-off). The RL will provide a 30 lux of red light on a vertical plane at the eye level.
DEVICEPlacebo Rhythmic Lighting Intervention
Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered at randomly varying frequencies of 20 Hz and 50 Hz, specifically avoiding the frequency of 40 Hz. The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level.
Sponsors
Icahn School of Medicine at Mount Sinai
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | baseline and during the light intervention | Electroencephalography (EEG) recordings - the change in 40 Hz gamma power, computed by calculating the difference between the average gamma power at baseline (T1) and during the light intervention (T2). This difference was obtained by subtracting baseline 40 Hz power from the intervention 40 Hz power to assess acute neural effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Subjective Sleepiness Using the Karolinska Sleepiness Scale (KSS) | Baseline and 1 hour after intervention (intervention is 2 hours) | The Karolinska Sleepiness Scale (KSS) outcome prompts participants to rate how sleepy or alert they are feeling on a scale ranging from 1 to 9, where 1 = "very alert," 3 = "rather alert," 5 = "neither alert nor sleepy," 7 = "sleepy, but no difficulty remaining awake," and 9 = "very sleepy, fighting sleep, an effort to remain awake." |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMariana Figueiro, PhD
Icahn School of Medicine at Mount Sinai
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health Control Health Participants - 1 hour intervention period where active lighting is experienced by participants or 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants then in the second intervention experiences the opposite of the first intervention. | 26 |
| Mild Cognitive Impairment Participants with Mild Cognitive Impairment - 1 hour intervention period where active lighting is experienced by participants or 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants then in the second intervention experiences the opposite of the first intervention. | 26 |
| Total | 52 |
Baseline characteristics
| Characteristic | Health Control | Mild Cognitive Impairment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 21 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 0 / 26 | 0 / 26 |
Outcome results
Primary
Change in Electroencephalography (EEG) Power at 40 Hertz (Hz)
Electroencephalography (EEG) recordings - the change in 40 Hz gamma power, computed by calculating the difference between the average gamma power at baseline (T1) and during the light intervention (T2). This difference was obtained by subtracting baseline 40 Hz power from the intervention 40 Hz power to assess acute neural effects
Time frame: baseline and during the light intervention
Population: EEG data not collected for first 12 participants. Protocol revised to include EEG data collection subsequently.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MCI - Inactive Placebo Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | Oz | 3.54 μV2/Hz | Standard Deviation 0.43 |
| MCI - Inactive Placebo Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | POz | 2.87 μV2/Hz | Standard Deviation 0.43 |
| MCI - Inactive Placebo Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | Pz | 2.69 μV2/Hz | Standard Deviation 0.53 |
| MCI - Active Tailored Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | Oz | 5.28 μV2/Hz | Standard Deviation 0.82 |
| MCI - Active Tailored Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | POz | 5.18 μV2/Hz | Standard Deviation 0.88 |
| MCI - Active Tailored Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | Pz | 5.24 μV2/Hz | Standard Deviation 0.94 |
| HC - Placebo Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | Pz | 3.86 μV2/Hz | Standard Deviation 0.51 |
| HC - Placebo Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | Oz | 2.83 μV2/Hz | Standard Deviation 0.53 |
| HC - Placebo Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | POz | 3.29 μV2/Hz | Standard Deviation 0.51 |
| HC - Active Tailored Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | Oz | 4.10 μV2/Hz | Standard Deviation 0.66 |
| HC - Active Tailored Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | POz | 3.57 μV2/Hz | Standard Deviation 0.64 |
| HC - Active Tailored Rhythmic Lighting | Change in Electroencephalography (EEG) Power at 40 Hertz (Hz) | Pz | 3.56 μV2/Hz | Standard Deviation 0.55 |
Secondary
Cognition Using a Working Memory Task
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Performance is assessed in percent correct and by measuring accuracy and Reaction Time (RT).
Time frame: 1 hour after intervention (intervention is 2 hours)
Secondary
Mean Change in Subjective Sleepiness Using the Karolinska Sleepiness Scale (KSS)
The Karolinska Sleepiness Scale (KSS) outcome prompts participants to rate how sleepy or alert they are feeling on a scale ranging from 1 to 9, where 1 = very alert, 3 = rather alert, 5 = neither alert nor sleepy, 7 = sleepy, but no difficulty remaining awake, and 9 = very sleepy, fighting sleep, an effort to remain awake.
Time frame: Baseline and 1 hour after intervention (intervention is 2 hours)
Population: EEG data not collected for first 12 participants. Protocol revised to include EEG data collection subsequently.~Outcome measure is comparing the two interventions Active Tailored Rhythmic Lighting vs Inactive Placebo Rhythmic Lighting regardless of cognitive status.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI - Inactive Placebo Rhythmic Lighting | Mean Change in Subjective Sleepiness Using the Karolinska Sleepiness Scale (KSS) | 0.44 score on a scale | Standard Deviation 0 |
| MCI - Active Tailored Rhythmic Lighting | Mean Change in Subjective Sleepiness Using the Karolinska Sleepiness Scale (KSS) | 0.49 score on a scale | Standard Deviation 0 |