Evaluation of Circadian OS Technology on Melatonin Suppression

NCT07095270 | Completed

• 1 other identifier: STUDY-24-00822
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Circadian Disruption

Outcome Measures

Primary Outcomes (1)

• Melatonin Level

  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.

  immediately prior to the iPad turning on, after 30 minutes of light exposure and after 60 minutes of light exposure

Secondary Outcomes (1)

• Karolinska Sleepiness Scale (KSS)

  immediately prior to the iPad turning on, after 30 minutes of light exposure and after 60 minutes of light exposure

Study Arms (2)

Active Condition - iPad with Circadian OS App

ACTIVE COMPARATOR

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

Device: Circadian OS software

Control Condition

PLACEBO COMPARATOR

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

Device: Circadian OS software

Interventions

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.

Active Condition - iPad with Circadian OS App; Control Condition

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults over the age of 30

You may not qualify if:

• Use of over-the-counter melatonin or prescription medications
• Obstructing cataracts, macular degeneration, or blindness
• Heart disease or high blood pressure

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 12204, United States

Location

Study Officials

• Mariana Figueiro, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Light and Health Research Center at Mount Sinai

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: July 7, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)