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Primary Objective: Evaluate how the Circadian OS iPad-based light intervention suppresses melatonin. This small pilot study is designed to validate the Circadian OS technology by testing physiological response using melatonin suppression. The study aims to evaluate how the Circadian OS iPad-based light intervention influences sleepiness as measured objectively via suppression of melatonin and subjectively via the Karolinska Sleepiness scale.
Aims: To test whether the Circadian OS app delivers sufficient circadian effective light that will result in measurable melatonin suppression (target suppression is 30% after 1 hour exposure)
Hypothesis: The Circadian OS app will deliver a Circadian Stimulus (CS) of 0.3 at the eye level and will result in 30% melatonin suppression after one hour using the device compared to less than 10% suppression without the Circadian OS app and the subjects will feel less sleepy (KSS score) when exposed to the Circadian OS app compared to no app
Outcomes: melatonin suppression will be calculated from saliva samples and subjective sleepiness as self-rated on the Karolinska Sleepiness Scale (KSS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Condition - iPad with Circadian OS App | Active Comparator | iPad with Circadian OS App ON - iPad screen brightness adjusted by Circadian OS software to provide circadian-effective light exposure. |
|
| Control Condition | Placebo Comparator | iPad with Circadian OS App OFF and iPad screen dimmed to lowest setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circadian OS software | Device | Circadian OS is a software program that runs on existing iPads. It utilizes the iPad capabilities to control and deliver circadian-effective light. |
| Measure | Description | Time Frame |
|---|---|---|
| Melatonin Level | Melatonin is a natural hormone that is mainly produced by a gland in the brain and helps regulate the body's natural sleep-wake cycle. | immediately prior to the iPad turning on, after 30 minutes of light exposure and after 60 minutes of light exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Karolinska Sleepiness Scale (KSS) | Sleepiness using the Karolinska Sleepiness Scale (KSS) which includes one item - participants will rate how sleep they are feeling on a scale of 0 to 9,with higher score indicating being the most sleepy | immediately prior to the iPad turning on, after 30 minutes of light exposure and after 60 minutes of light exposure |
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Inclusion Criteria:
• Healthy adults over the age of 30
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariana Figueiro, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 12204 | United States |
no individual results will be shared, only overall averages
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