Breath Biomarkers for Sleep Loss and Circadian Timing

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Disorders, Intrinsic; Sleep Disorders, Circadian Rhythm; Advanced Sleep Phase Syndrome (ASPS); Delayed Sleep Phase Syndrome; Shift-Work Sleep Disorder; Delayed Sleep Phase; Non-24 Hour Sleep-Wake Disorder; Advanced Sleep Phase Syndrome; Advanced Sleep Phase; Irregular Sleep-Wake Syndrome; Shift Work Type Circadian Rhythm Sleep Disorder
• Intervention / Treatment: Behavioral: Short Nap Intervention; Behavioral: No Nap Intervention

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 Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will be recruited from the surrounding community.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the change in composition of chemical analytes from the breath test	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.	Study day 1
Change in composition of chemical analytes from the breath test	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.	Study day 1
Circadian differences in composition of chemical analytes from the breath test	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).	Study day 1

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Jeanne F Duffy, MBA, PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Sleep; Circadian Rhythms; Circadian Rhythm Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Disease; Occupational Diseases; Chronobiology Disorders; Syndrome; Sleep Wake Disorders; Parasomnias; Sleep Disorders, Intrinsic; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 2019-P-001628

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No