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OpenTrials
Completed

NCT Number: NCT07095270

Evaluation of Circadian OS Technology on Melatonin Suppression

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.

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Key information

Conditions

Circadian Disruption

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 12204, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Melatonin Level

    Time frame: 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 outcomes

  1. Karolinska Sleepiness Scale (KSS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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