Breath Biomarkers for Sleep Loss and Circadian Timing

Mass General Brigham

Status: Terminated

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

Treatments: Behavioral: No Nap Intervention; Behavioral: Short Nap Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03980340

2019-P-001628

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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