Evaluation of Circadian OS Technology on Melatonin Suppression

Not Applicable

Recruiting

• Conditions: Circadian Disruption

• Registration Number: NCT07095270
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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)

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States