Clinical trial NCT03980340: Breath Biomarkers for Sleep Loss and Circadian Timing
Official title: Breath Biomarkers for Sleep Loss and Circadian Timing
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers will be recruited from the surrounding community.

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.

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

Primary outcomes:
measure: Comparison of the change in composition of chemical analytes from the breath test
timeFrame: Study day 1
measure: Change in composition of chemical analytes from the breath test
timeFrame: Study day 1
measure: Circadian differences in composition of chemical analytes from the breath test
timeFrame: Study day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeanne F Duffy, MBA, PhD
role: PRINCIPAL_INVESTIGATOR
References: