NCT03980340

Breath Biomarkers for Sleep Loss and Circadian Timing

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Insufficient sleep has both health and safety risks, but currently there are no quick, accurate and inexpensive ways to measure sleep deficiency. The current study aims to use a cutting-edge technology, small molecule analysis (e.g. metabolomics), to detect compounds in breath that reliably change with sleep-wake state and those whose levels vary by time of day.

Detailed description

The goal of the study is to use a small molecule analysis (e.g. metabolomics) device to measure compounds in breath that may change with sleep-wake state and compounds that vary by time of day. Participants will be fitted with a plastic mask connected to the device for a breath analysis test for about 20 minutes. Then, participants may be asked to lie down and take a nap or to remain sitting/lying down for 1-2 hours. After such time, participants will be asked to complete another \~20 minute breath analysis test. Participants will be asked to complete questionnaires throughout the study session. Investigators may ask participants to provide up to two saliva samples during the study session. Participants will also be asked to complete a pre-study diary to document sleep/wake times, diet, and medications for the day before the study session. Participants may be asked if they would be willing to take part in an additional study session on another day.

Conditions

• Shift-Work Sleep Disorder
• Shift Work Type Circadian Rhythm Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Disorders, Intrinsic
• Advanced Sleep Phase Syndrome (ASPS)
• Advanced Sleep Phase Syndrome
• Advanced Sleep Phase
• Delayed Sleep Phase
• Delayed Sleep Phase Syndrome
• Non-24 Hour Sleep-Wake Disorder
• Irregular Sleep-Wake Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Short Nap Intervention	Study participants may be asked to have a 1-2 hour nap in between the breath analysis tests.
BEHAVIORAL	No Nap Intervention	Study participants may be asked to sit or lay down remaining awake for 1-2 hours in between breath analysis tests.

Timeline

• Start date: 2021-01-28
• Primary completion: 2025-01-31
• Completion: 2025-03-31
• First posted: 2019-06-10
• Last updated: 2025-08-03

Locations

1 site across 1 country: United States