InflammationNCT04955431
Circadian Rhythm Disruption Effects on Smoke Inhalation
A study testing Sleep Restriction and Normal Sleep in people with Inflammation and Sleep Deprivation, run by University of Montana at 1 site in United States.
Trial summary
Particulate matter exposure during smoke inhalation provokes inflammatory immune responses in people exposed to burning biomass including fire fighters and civilians. Persistent occupational exposure to particulate matter represents a unique hazard for firefighters, underpinning a burgeoning research area. Read more about this study
- Who is it for?
- Ages 18 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Sleep Deprivation, Circadian Rhythm Sleep Disorder, Shift Work Type
- What is being tested?
- Sleep Restriction and Normal Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 17 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Male
- 18 - 44 years of age
Who cannot join
- Preexisting cardiometabolic and/or pulmonary diseases
- Preexisting sleep disorder
- Smoking (current or within last year)
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Integrative Physiology and Athletic Training
Missoula, Montana, 59812
About this study
Official title: The Effects of Circadian Rhythm Disruption on the Inflammatory Response to Particulate Matter Exposure From Woodsmoke
Particulate matter exposure during smoke inhalation provokes inflammatory immune responses in people exposed to burning biomass including fire fighters and civilians. Persistent occupational exposure to particulate matter represents a unique hazard for firefighters, underpinning a burgeoning research area. This trial will evaluate the effects of sleep deprivation and circadian rhythm disruption on the inflammatory response to woodsmoke associated particulate matter exposure. Participants will undergo 2 experimental trials in a randomized cross-over design. Participants will have either an 8-hour sleep opportunity or a 4-hour sleep opportunity prior to reporting to lab for a 45 minute simulated firefighting trial (wood smoke associated particulate matter filtered to 2.5 um at a concentration of 250 ug/m^3, while exercising at a moderate intensity). The effects of sleep restriction and simulated firefighting will be measured.
Read the detailed description
Participants: Healthy college age males (n = 15), free from disordered sleep and without recent trans-meridian travel (within the last 2 weeks) will be recruited for this study. Participants will complete chronotype questionnaires (Morningness-Eveningness Questionnaire; MEQ, Munich Chronotype Questionnaire; MCTQ) to establish intermediate chronotypes. This will minimize the effect of circadian preference on the morning exposure to smoke. Participants will subsequently be outfitted with activity monitors (ActiCal) to monitor sleep and physical activity throughout the experimental duration. Participants will be asked to maintain a normal sleep schedule for at least 3 days leading up to the experimental trials and keep a sleep log to verify.
Experimental Trials: Participants will undergo 2 experimental trials in a randomized cross-over design, with at least 1 week washout period between trials; 1) NS-250: Normal Sleep with exposure to woodsmoke at 250 µg/m^3, and RS-250: Restricted Sleep with exposure to woodsmoke at 250 µg/m^3. Participants will have an 8-hour sleep opportunity in their own home during the NS trials (22:00-06:00), and a 4-hour sleep opportunity during the RS trials (00:00-04:00). In all trials, participants will report to the laboratory at 07:30 the morning after the experimental sleep night. PM exposure will occur from 08:00-08:45 while cycling at 70% heart rate reserve (HRR) to simulate the physical demands of firefighting.
Exhaled Breath Condensate (EBC): EBC will be collected using standardized 10 minute collection techniques. In order to preserve sample integrity for potentially labile biomarkers (e.g., oxidative stress), sample pH will be measured immediately prior to aliquoting in multiple cryotubes (500-700µl), flash freezing, and storage at -80 degrees C until further assay. Standardized biomarker panels for oxidative stress and inflammation will be performed using a single thaw approach.
Inflammatory biomarker analysis: Blood will be collected into heparinized vacutainers before (PRE) and immediately following (POST) PM2.5 exposure and spun down for plasma collection. Plasma will be assayed for inflammatory biomarkers (interleukin (IL)-6, tumor necrosis factor (TNF)-α, pentraxin-3, and C-reactive protein (CRP)) using standard enzyme linked immunosorbent assays (ELISA).
Circadian Rhythm Assessment: Throughout the experimental protocol, circadian rhythms will be assessed in two ways; 1) Actigraphy and 2) Clock gene expression in buccal cell swabs. Acticals will be worn throughout to gather sleep variables (timing, duration, quality). Clock gene expression (CLOCK, BMAL1, PER2) will be measured in swabs taken from the cheek at 6 hour intervals (00:00, 06:00, 12:00, 18:00) to assess the effects of sleep deprivation on the molecular circadian rhythm. Cheek swabs will be immediately placed in RNA stabilization buffer until isolation. Swabs taken at 00:00 will be performed with minimal exposure to light to avoid disruption of sleep. These methods have been used previously to assess normal and disrupted sleep.
- Conditions
- Inflammation, Sleep Deprivation, Circadian Rhythm Sleep Disorder, Shift Work Type, Smoke Inhalation
- Being tested
- Sleep Restriction, Normal Sleep
- Medical subject headings
- Inflammation, Sleep Deprivation, Sleep Disorders, Circadian Rhythm, Smoke Inhalation Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep RestrictionBehavioural
Also called Circadian Rhythm Disruption, SR
Participants will be allowed ~4 hour sleep opportunity during the restricted night of sleep prior to reporting to lab for a simulated firefighting session.
Normal SleepBehavioural
Also called NS
Participants will be allowed ~8 hour sleep opportunity the night of sleep prior to reporting to lab for a simulated firefighting session.
| Study group | Role | What they receive |
|---|---|---|
| Normal Sleep (with 250 ug/m^3 PM2.5) | Placebo comparator | Participants will have a normal sleep opportunity the night prior to reporting to the lab for the simulated firefighting session (250 ug/m^3 PM2.5 with moderate intensity exercise). Receives: Behavioral: Normal Sleep |
| Restricted Sleep (with 250 ug/m^3 PM2.5) | Experimental | Participants will have a restricted sleep opportunity (~4 hours) the night prior to reporting to the lab for the simulated firefighting session (250 ug/m^3 PM2.5 with moderate intensity exercise). Receives: Behavioral: Sleep Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Inflammation
IL-6 will be measured in the plasma
Measured: samples collected at baseline, immediately post exposure
Secondary outcomes (1)
Exhaled Breath Condensate Pentraxin-3
Pentraxin-3 will be measured in EBC of participants at baseline (PRE) and after exercise (POST) on two trial days. One trial day will be after a normal night of sleep (Normal Sleep) and the other trial will be after sleep restriction to 4 hours (Restricted Sleep). The value is determined through ELISA method, represented in ng/mL, where higher levels indicate worse response.
Measured: samples collected at baseline, immediately post exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start24 Jan 2022
- Primary completion17 Mar 2022
- Study completion17 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross-over design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nevada, Las Vegas
- Responsible party
- Principal investigator, John Quindry, University of Montana
- Investigators
- John C Quindry, PhD, Principal investigator, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955431
- Sponsor's protocol ID
- IRB# is 83-21
- Status last verified
- May 2025
- First submitted
- 21 Jun 2021
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Blinded anonymized outcomes data will be shared via publication and presentation of results.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Circadian Rhythm Disruption on the Inflammatory Response to Particulate Matter Exposure From Woodsmoke
- ClinicalTrials.gov ID
- NCT04955431
- Acronym / sponsor ID
- IRB# is 83-21
- Conditions
- Inflammation, Sleep Deprivation, Circadian Rhythm Sleep Disorder, Shift Work Type, Smoke Inhalation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Collaborators
- University of Nevada, Las Vegas
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Apr 2022 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Particulate matter exposure during smoke inhalation provokes inflammatory immune responses in people exposed to burning biomass including fire fighters and civilians. Persistent occupational exposure to particulate matter represents a unique hazard for firefighters, underpinning a burgeoning research area. This trial will evaluate the effects of sleep deprivation and circadian rhythm disruption on the inflammatory response to woodsmoke associated particulate matter exposure. Participants will undergo 2 experimental trials in a randomized cross-over design. Participants will have either an 8-hour sleep opportunity or a 4-hour sleep opportunity prior to reporting to lab for a 45 minute simulated firefighting trial (wood smoke associated particulate matter filtered to 2.5 um at a concentration of 250 ug/m^3, while exercising at a moderate intensity). The effects of sleep restriction and simulated firefighting will be measured.
Detailed description
Participants: Healthy college age males (n = 15), free from disordered sleep and without recent trans-meridian travel (within the last 2 weeks) will be recruited for this study. Participants will complete chronotype questionnaires (Morningness-Eveningness Questionnaire; MEQ, Munich Chronotype Questionnaire; MCTQ) to establish intermediate chronotypes. This will minimize the effect of circadian preference on the morning exposure to smoke. Participants will subsequently be outfitted with activity monitors (ActiCal) to monitor sleep and physical activity throughout the experimental duration. Participants will be asked to maintain a normal sleep schedule for at least 3 days leading up to the experimental trials and keep a sleep log to verify.
Experimental Trials: Participants will undergo 2 experimental trials in a randomized cross-over design, with at least 1 week washout period between trials; 1) NS-250: Normal Sleep with exposure to woodsmoke at 250 µg/m^3, and RS-250: Restricted Sleep with exposure to woodsmoke at 250 µg/m^3. Participants will have an 8-hour sleep opportunity in their own home during the NS trials (22:00-06:00), and a 4-hour sleep opportunity during the RS trials (00:00-04:00). In all trials, participants will report to the laboratory at 07:30 the morning after the experimental sleep night. PM exposure will occur from 08:00-08:45 while cycling at 70% heart rate reserve (HRR) to simulate the physical demands of firefighting.
Exhaled Breath Condensate (EBC): EBC will be collected using standardized 10 minute collection techniques. In order to preserve sample integrity for potentially labile biomarkers (e.g., oxidative stress), sample pH will be measured immediately prior to aliquoting in multiple cryotubes (500-700µl), flash freezing, and storage at -80 degrees C until further assay. Standardized biomarker panels for oxidative stress and inflammation will be performed using a single thaw approach.
Inflammatory biomarker analysis: Blood will be collected into heparinized vacutainers before (PRE) and immediately following (POST) PM2.5 exposure and spun down for plasma collection. Plasma will be assayed for inflammatory biomarkers (interleukin (IL)-6, tumor necrosis factor (TNF)-α, pentraxin-3, and C-reactive protein (CRP)) using standard enzyme linked immunosorbent assays (ELISA).
Circadian Rhythm Assessment: Throughout the experimental protocol, circadian rhythms will be assessed in two ways; 1) Actigraphy and 2) Clock gene expression in buccal cell swabs. Acticals will be worn throughout to gather sleep variables (timing, duration, quality). Clock gene expression (CLOCK, BMAL1, PER2) will be measured in swabs taken from the cheek at 6 hour intervals (00:00, 06:00, 12:00, 18:00) to assess the effects of sleep deprivation on the molecular circadian rhythm. Cheek swabs will be immediately placed in RNA stabilization buffer until isolation. Swabs taken at 00:00 will be performed with minimal exposure to light to avoid disruption of sleep. These methods have been used previously to assess normal and disrupted sleep.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cross-over design
| Arm | Type | Receives |
|---|---|---|
| Normal Sleep (with 250 ug/m^3 PM2.5) | Placebo comparator | Behavioral: Normal SleepParticipants will have a normal sleep opportunity the night prior to reporting to the lab for the simulated firefighting session (250 ug/m^3 PM2.5 with moderate intensity exercise). |
| Restricted Sleep (with 250 ug/m^3 PM2.5) | Experimental | Behavioral: Sleep RestrictionParticipants will have a restricted sleep opportunity (~4 hours) the night prior to reporting to the lab for the simulated firefighting session (250 ug/m^3 PM2.5 with moderate intensity exercise). |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Male
- 18 - 44 years of age
Key exclusion criteria (3 listed)
- Preexisting cardiometabolic and/or pulmonary diseases
- Preexisting sleep disorder
- Smoking (current or within last year)
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 |
|---|---|---|
| Sleep RestrictionAlso: Circadian Rhythm Disruption, SRParticipants will be allowed ~4 hour sleep opportunity during the restricted night of sleep prior to reporting to lab for a simulated firefighting session. | Behavioural | Restricted Sleep (with 250 ug/m^3 PM2.5) |
| Normal SleepAlso: NSParticipants will be allowed ~8 hour sleep opportunity the night of sleep prior to reporting to lab for a simulated firefighting session. | Behavioural | Normal Sleep (with 250 ug/m^3 PM2.5) |
Primary outcome
Blood Inflammation
Time frame: samples collected at baseline, immediately post exposure
IL-6 will be measured in the plasma
1 secondary outcome
Exhaled Breath Condensate Pentraxin-3
Time frame: samples collected at baseline, immediately post exposure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Blinded anonymized outcomes data will be shared via publication and presentation of results.
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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.
John C Quindry, PhD principal investigator
University of Montana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Restriction and Normal Sleep in people with Inflammation and Sleep Deprivation, run by University of Montana 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 May 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Inflammation (time frame: samples collected at baseline, immediately post exposure). 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 30 May 2025.