Evaluation of Circadian OS Technology on Melatonin Suppression

NCT ID: NCT07095270

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Circadian Disruption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active Condition - iPad with Circadian OS App

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

Group Type ACTIVE_COMPARATOR

Circadian OS software

Intervention Type DEVICE

Circadian OS is a software program that runs on existing iPads. It utilizes the iPad capabilities to control and deliver circadian-effective light.

Control Condition

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

Group Type PLACEBO_COMPARATOR

Circadian OS software

Intervention Type DEVICE

Circadian OS is a software program that runs on existing iPads. It utilizes the iPad capabilities to control and deliver circadian-effective light.

Interventions

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Circadian 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Mariana Figueiro

Director, Light and Health Research Center at Mount Sinai

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariana Figueiro, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY-24-00822

Identifier Type: -

Identifier Source: org_study_id

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