Breath Biomarkers for Sleep Loss and Circadian Timing

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03980340
Collaborator
(none)
5
1
20
0.2

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
5 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Breath Biomarkers for Sleep Loss and Circadian Timing
Actual Study Start Date :
Jan 28, 2021
Actual Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Sep 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Comparison of the change in composition of chemical analytes from the breath test [Study day 1]

    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.

  2. Change in composition of chemical analytes from the breath test [Study day 1]

    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.

  3. Circadian differences in composition of chemical analytes from the breath test [Study day 1]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

  • Principal Investigator: Jeanne F Duffy, MBA, PhD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeanne Duffy, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT03980340
Other Study ID Numbers:
  • 2019-P-001628
First Posted:
Jun 10, 2019
Last Update Posted:
Nov 4, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jeanne Duffy, Principal Investigator, Brigham and Women's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 4, 2021