Breath Biomarkers for Sleep Loss and Circadian Timing

NCT03980340 | Terminated

• 1 other identifier: 2019-P-001628
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Sleep; Circadian Rhythms; Circadian Rhythm Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Short Nap Intervention BEHAVIORAL

Study participants may be asked to have a 1-2 hour nap in between the breath analysis tests.

No Nap Intervention BEHAVIORAL

Study participants may be asked to sit or lay down remaining awake for 1-2 hours in between breath analysis tests.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will be recruited from the surrounding community.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples may be collected and assayed for cortisol.

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Sleep Disorders, Intrinsic; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Officials

• Jeanne F Duffy, MBA, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 10, 2019
• Study Start: January 28, 2021
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

US (1)