Breath Biomarkers for Sleep Loss and Circadian Timing

NCT ID: NCT03980340

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2025-03-31

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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Short Nap Intervention

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeanne Duffy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeanne F Duffy, MBA, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2019-P-001628

Identifier Type: -

Identifier Source: org_study_id