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出境医 / 临床实验 / Breath Biomarkers for Sleep Loss and Circadian Timing

Breath Biomarkers for Sleep Loss and Circadian Timing

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.

Condition or disease Intervention/treatment
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 Behavioral: Short Nap Intervention Behavioral: No Nap Intervention

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Breath Biomarkers for Sleep Loss and Circadian Timing
Actual Study Start Date : January 28, 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Comparison of the change in composition of chemical analytes from the breath test [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).


Biospecimen Retention:   Samples Without DNA
Saliva samples may be collected and assayed for cortisol.

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 23, 2019
First Posted Date June 10, 2019
Last Update Posted Date March 11, 2021
Actual Study Start Date January 28, 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2019)
  • Comparison of the change in composition of chemical analytes from the breath test [ Time Frame: 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.
  • Change in composition of chemical analytes from the breath test [ Time Frame: 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.
  • Circadian differences in composition of chemical analytes from the breath test [ Time Frame: 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Breath Biomarkers for Sleep Loss and Circadian Timing
Official Title Breath Biomarkers for Sleep Loss and Circadian Timing
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Saliva samples may be collected and assayed for cortisol.
Sampling Method Non-Probability Sample
Study Population Healthy volunteers will be recruited from the surrounding community.
Condition
  • 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
Intervention
  • Behavioral: Short Nap Intervention
    Study participants may be asked to have a 1-2 hour nap in between the breath analysis tests.
  • 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 6, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Research Study Coordinator 617-525-8719 BreathStudyResearch@partners.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03980340
Other Study ID Numbers 2019-P-001628
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Jeanne Duffy, Brigham and Women's Hospital
Study Sponsor Brigham and Women's Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jeanne F Duffy, MBA, PhD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date March 2021

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