Shift-Work Sleep DisorderNCT03980340
Breath Biomarkers for Sleep Loss and Circadian Timing
An observational study of Shift-Work Sleep Disorder and Shift Work Type Circadian Rhythm Sleep Disorder, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Sleep Disorder, Shift Work Type Circadian Rhythm Sleep Disorder, Sleep Disorders, Circadian Rhythm
- What is being tested?
- Short Nap Intervention and No Nap Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2021to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers will be recruited from the surrounding community.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- 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
- Being tested
- Short Nap Intervention, No Nap Intervention
- Keywords
- Sleep, Circadian Rhythms, Circadian Rhythm Disorder
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Sleep Disorders, Intrinsic, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Nap InterventionBehavioural
Study participants may be asked to have a 1-2 hour nap in between the breath analysis tests.
No Nap InterventionBehavioural
Study participants may be asked to sit or lay down remaining awake for 1-2 hours in between breath analysis tests.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study day 1
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.
Measured: Study day 1
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).
Measured: Study day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start28 Jan 2021
- Primary completion31 Jan 2025
- Study completion31 Mar 2025
Why it stopped: Funding to carry out studies no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-Work Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanne Duffy, Brigham and Women's Hospital
- Investigators
- Jeanne F Duffy, MBA, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980340
- Sponsor's protocol ID
- 2019-P-001628
- Status last verified
- Jul 2025
- First submitted
- 23 May 2019
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Biomarkers for Sleep Loss and Circadian Timing
- ClinicalTrials.gov ID
- NCT03980340
- Acronym / sponsor ID
- 2019-P-001628
- 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
- Keywords
- Sleep, Circadian Rhythms, Circadian Rhythm Disorder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding to carry out studies no longer available.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers will be recruited from the surrounding community.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Nap InterventionStudy participants may be asked to have a 1-2 hour nap in between the breath analysis tests. | Behavioural | – |
| No Nap InterventionStudy participants may be asked to sit or lay down remaining awake for 1-2 hours in between breath analysis tests. | Behavioural | – |
Primary outcome
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).
Results and safety
The study was stopped early (reason given: Funding to carry out studies no longer available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne F Duffy, MBA, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shift-Work Sleep Disorder and Shift Work Type Circadian Rhythm Sleep Disorder, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding to carry out studies no longer available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the change in composition of chemical analytes from the breath test (time frame: Study day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.