Evaluation of Circadian OS Technology on Melatonin Suppression

Mount Sinai Health System

Status: Completed

Conditions: Circadian Disruption

Treatments: Device: Circadian OS software

Study type: Interventional

Funder types: Other

Identifiers

NCT07095270

STUDY-24-00822

Details and patient eligibility

About

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.

Full 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)

Enrollment: 10 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Active Condition - iPad with Circadian OS App

Active Comparator group

Description:

iPad with Circadian OS App ON - iPad screen brightness adjusted by Circadian OS software to provide circadian-effective light exposure.

Treatment:

Device: Circadian OS software

Control Condition

Placebo Comparator group

Description:

iPad with Circadian OS App OFF and iPad screen dimmed to lowest setting

Treatment:

Device: Circadian OS software