Breath Biomarkers for Sleep Loss and Circadian Timing

Active, not recruiting

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

• Registration Number: NCT03980340
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-10
• Study Start: 2021-01-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-01-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Healthy Adults who are able to fall asleep in the study conditions
• Beginning 2 hours before the study, participants will be asked to refrain from brushing their teeth, using mouthwash, eating or drinking anything (other than water), chewing gum, smoking, etc., until the study is complete.

Exclusion Criteria

• Individuals on special diets (such as a very low carbohydrate diet) may be excluded
• Acute or debilitating medical condition
• Recent history of dental problems (gum disease, abcess, surgery) or current dental or mouth pain
• Current use of stimulants, hypnotics, tranquilizers, Central Nervous System active substances, and/or antibiotics.
• Use of products containing nicotine 24 hours prior to study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circadian differences in composition of chemical analytes from the breath test	Study day 1	The analytes present in breath samples after a short nap (in the Short Nap Intervention) will be analyzed for differences in chemical composition depending on time of day (circadian variation).
Comparison of the change in composition of chemical analytes from the breath test	Study day 1	The change in composition of chemical analytes from the breath analysis tests will be compared between the Short Nap Intervention and No Nap Intervention groups to see if there is a sleep-related change in the components of breath.
Change in composition of chemical analytes from the breath test	Study day 1	The analytes present in individual subject's breath samples before and after a short nap (in the Short Nap Intervention) will be analyzed for differences in chemical composition.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States