Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG072762 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lighting | Active Comparator |
|
|
| Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lighting | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Rhythmic Lighting Intervention | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and during the light intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mariana Figueiro, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Light and Health Research Center | Menands | New York | 12204 | United States | ||
| Icahn School of Medicine at Mount Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2265922 | Background | Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241. | |
| 15817019 | Background | Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Health Control Group 1 | Healthy Control - Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lighting 1 hour intervention period where active lighting is experienced by participants. then 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. |
| FG001 | Health Control Group 2 | Healthy Control - Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lighting 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. then 1 hour intervention period where active lighting is experienced by participants. |
| FG002 | Mild Cognitive Impairment Group 1 | Mild Cognitive Impairment - Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lighting 1 hour intervention period where active lighting is experienced by participants. then 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. |
| FG003 | Mild Cognitive Impairment Group 2 | Mild Cognitive Impairment - Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lighting 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. then 1 hour intervention period where active lighting is experienced by participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Experimental Condition |
| |||||||||||||
| Second Experimental Condition |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | EEG data not collected for first 12 participants. Protocol revised to include EEG data collection subsequently. | Posted | Mean | Standard Deviation | μV2/Hz | baseline and during the light intervention |
|
2 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MCI - Active Tailored Rhythmic Lighting | 1 hour intervention period where active lighting is experienced by participants. Tailored 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mariana Figueiro PhD | Icahn School Of Medicine at Mount Sinai | 212-241-6500 | Mariana.Figueiro@mountsinai.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2024 | Sep 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2024 | Sep 20, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo Rhythmic Lighting Intervention | Device | 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. |
|
| Baseline and 1 hour after intervention (intervention is 2 hours) |
| New York |
| New York |
| 10029 |
| United States |
| 1947597 | Background | Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | MCI - Active Tailored Rhythmic Lighting | 1 hour intervention period where active lighting is experienced by participants. Tailored 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. |
| OG002 | HC - Placebo Rhythmic Lighting | 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. Placebo Rhythmic Lighting Intervention: Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz). The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level. |
| OG003 | HC - Active Tailored Rhythmic Lighting | 1 hour intervention period where active lighting is experienced by participants. Tailored 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. |
|
|
| 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." | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 hour after intervention (intervention is 2 hours) |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | MCI - Inactive Placebo Rhythmic Lighting | 1 hour intervention period where active lighting is experienced by participants. Tailored 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. | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | HC - Active Tailored Rhythmic Lighting | 1 hour intervention period where active lighting is experienced by participants. Tailored 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. | 0 | 26 | 0 | 26 | 0 | 26 |
| EG003 | MC - Inactive Placebo Rhythmic Lighting | 1 hour intervention period where active lighting is experienced by participants. Tailored 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. | 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided