Breath Biomarkers for Sleep Loss and Circadian Timing

  • STATUS
    Recruiting
  • days left to enroll
    3
  • participants needed
    50
  • sponsor
    Brigham and Women's Hospital
Updated on 8 July 2021
Investigator
Research Study Coordinator
Primary Contact
Brigham and Women's Hospital (2.3 mi away) Contact

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.

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.

Details
Condition Circadian Rhythm Sleep Disorder, Paradoxical insomnia, Shift Work Type Circadian Rhythm Sleep Disorder, Delayed Sleep Phase, delayed sleep phase syndrome, Advanced Sleep Phase, Irregular Sleep-Wake Syndrome, Irregular Sleep-Wake Syndrome, Irregular Sleep-Wake Syndrome, Irregular Sleep-Wake Syndrome
Treatment Short Nap Intervention, No Nap Intervention
Clinical Study IdentifierNCT03980340
SponsorBrigham and Women's Hospital
Last Modified on8 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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