Breath Biomarkers for Sleep Loss and Circadian Timing

Sleep Disorders, Circadian Rhythm Clinical Trial

Official title:

Breath Biomarkers for Sleep Loss and Circadian Timing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03980340
• Other study ID #: 2019-P-001628
• Status: Active, not recruiting
• Start date: January 28, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Short Nap Intervention
Study participants may be asked to have a 1-2 hour nap in between the breath analysis tests.
• No Nap Intervention
Study participants may be asked to sit or lay down remaining awake for 1-2 hours in between breath analysis tests.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the change in composition of chemical analytes from the breath test	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.	Study day 1
Primary	Change in composition of chemical analytes from the breath test	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.	Study day 1
Primary	Circadian differences in composition of chemical analytes from the breath test	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).	Study day 1