Trial Outcomes & Findings for Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment (NCT NCT05411822)
NCT ID: NCT05411822
Last Updated: 2025-06-24
Results Overview
Saliva samples collected for melatonin levels for the different conditions. Blue light (λmax = 451 nm) on axis and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Green light (λmax = 522 nm) on and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Dim-light control condition: (\< 5 lux at the eye) for 30 min
COMPLETED
NA
36 participants
post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks)
2025-06-24
Participant Flow
Participant milestones
| Measure |
Participants With Mild Cognitive Impairment
Every participant experienced all 5 conditions:
Blue light (λmax = 451 nm) on axis and off axis.
Green light (λmax = 522 nm) on and off axis
Dim-light control condition (\< 5 lux at the eye) for 30 min
each narrowband source will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye.
|
Matched Control
Healthy Age-Matched Control
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
|
Overall Study
COMPLETED
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Participants With Mild Cognitive Impairment
Every participant experienced all 5 conditions:
Blue light (λmax = 451 nm) on axis and off axis.
Green light (λmax = 522 nm) on and off axis
Dim-light control condition (\< 5 lux at the eye) for 30 min
each narrowband source will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye.
|
Matched Control
Healthy Age-Matched Control
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants With Mild Cognitive Impairment
n=17 Participants
Every participant experienced all 5 conditions:
Blue light (λmax = 451 nm) on axis and off axis.
Green light (λmax = 522 nm) on and off axis
Dim-light control condition (\< 5 lux at the eye) for 30 min
each narrowband source will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye.
|
Healthy Age-Matched Control
n=19 Participants
Healthy Age-Matched Control
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 7.4 • n=17 Participants
|
58.7 years
STANDARD_DEVIATION 7.6 • n=19 Participants
|
58.8 years
STANDARD_DEVIATION 7.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=17 Participants
|
13 Participants
n=19 Participants
|
28 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=17 Participants
|
6 Participants
n=19 Participants
|
8 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks)Saliva samples collected for melatonin levels for the different conditions. Blue light (λmax = 451 nm) on axis and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Green light (λmax = 522 nm) on and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Dim-light control condition: (\< 5 lux at the eye) for 30 min
Outcome measures
| Measure |
Mild Cognitive Impairment
n=13 Participants
Participants who have mild cognitive impairment
|
Healthy Control
n=15 Participants
Participants who are healthy.
|
|---|---|---|
|
Melatonin Levels
Dim Light
|
1.53 pg/mL
Standard Deviation 0.7
|
1.27 pg/mL
Standard Deviation 0.3
|
|
Melatonin Levels
Blue light (λmax = 451 nm) on axis
|
0.89 pg/mL
Standard Deviation 0.49
|
0.84 pg/mL
Standard Deviation 0.51
|
|
Melatonin Levels
Blue light (λmax = 451 nm) off axis
|
0.9 pg/mL
Standard Deviation 0.46
|
0.68 pg/mL
Standard Deviation 0.21
|
|
Melatonin Levels
Green light (λmax = 522 nm) on axis
|
0.73 pg/mL
Standard Deviation 0.14
|
0.73 pg/mL
Standard Deviation 0.3
|
|
Melatonin Levels
Green light (λmax = 522 nm) off axis
|
0.82 pg/mL
Standard Deviation 0.39
|
0.79 pg/mL
Standard Deviation 0.24
|
Adverse Events
Mild Cognitive Impairment - Lighting Intervention Blue - On Axis
Mild Cognitive Impairment - Blue - Off Axis
Mild Cognitive Impairment - Lighting Intervention Green - On Axis
Mild Cognitive Impairment - Green - Off Axis
Mild Cognitive Impairment - Dim Light
Healthy Control - Lighting Intervention Blue - On Axis
Healthy Control - Blue - Off Axis
Health Control - Lighting Intervention Green - On Axis
Healthy Control - Green - Off Axis
Health Control Dim Light
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mariana Figueiro, PhD
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place