Circadian Disruption
Conditions
Brief summary
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.
Detailed description
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)
Interventions
DEVICECircadian OS software
Circadian OS is a software program that runs on existing iPads. It utilizes the iPad capabilities to control and deliver circadian-effective light.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
• Healthy adults over the age of 30
Exclusion criteria
* Use of over-the-counter melatonin or prescription medications * Obstructing cataracts, macular degeneration, or blindness * Heart disease or high blood pressure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Melatonin Level | immediately prior to the iPad turning on, after 30 minutes of light exposure and after 60 minutes of light exposure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Karolinska Sleepiness Scale (KSS) | immediately prior to the iPad turning on, after 30 minutes of light exposure and after 60 minutes of light exposure | 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 |
Countries
United States
Outcome results
None listed