Trial Outcomes & Findings for Circadian Rhythm Disruption Effects on Smoke Inhalation (NCT NCT04955431)
NCT ID: NCT04955431
Last Updated: 2025-05-30
Results Overview
IL-6 will be measured in the plasma
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
samples collected at baseline, immediately post exposure
Results posted on
2025-05-30
Participant Flow
Participant milestones
| Measure |
Normal Sleep (With 250 ug/m^3 PM2.5) Then Restricted Sleep (With 250 ug/m^3 PM2.5)
Participants will complete two sessions in the lab. During their first session, they 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).
Normal Sleep: Participants will be allowed \~8 hour sleep opportunity the night of sleep prior to reporting to lab for a simulated firefighting session.
During their second session, 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).
Sleep Restriction: Participants will be allowed \~4 hour sleep opportunity during the restricted night of sleep prior to reporting to lab for a simulated firefighting session.
|
Restricted Sleep (With 250 ug/m^3 PM2.5) Then Normal Sleep (With 250 ug/m^3 PM2.5)
Participants will complete two sessions in the lab. During their first session, 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).
Sleep Restriction: Participants will be allowed \~4 hour sleep opportunity during the restricted night of sleep prior to reporting to lab for a simulated firefighting session.
During their second session, 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).
Normal Sleep: Participants will be allowed \~8 hour sleep opportunity the night of sleep prior to reporting to lab for a simulated firefighting session.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Circadian Rhythm Disruption Effects on Smoke Inhalation
Baseline characteristics by cohort
| Measure |
Normal Sleep (With 250 ug/m^3 PM2.5) Then Restricted Sleep (With 250 ug/m^3 PM2.5)
n=5 Participants
Participants will complete two sessions in the lab. During their first session, they 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).
Normal Sleep: Participants will be allowed \~8 hour sleep opportunity the night of sleep prior to reporting to lab for a simulated firefighting session.
During their second session, 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).
Sleep Restriction: Participants will be allowed \~4 hour sleep opportunity during the restricted night of sleep prior to reporting to lab for a simulated firefighting session.
|
Restricted Sleep (With 250 ug/m^3 PM2.5) Then Normal Sleep (With 250 ug/m^3 PM2.5)
n=5 Participants
Participants will complete two sessions in the lab. During their first session, 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).
Sleep Restriction: Participants will be allowed \~4 hour sleep opportunity during the restricted night of sleep prior to reporting to lab for a simulated firefighting session.
During their second session, 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).
Normal Sleep: Participants will be allowed \~8 hour sleep opportunity the night of sleep prior to reporting to lab for a simulated firefighting session.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.8 years
STANDARD_DEVIATION 3.56 • n=5 Participants
|
25.0 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
24.4 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Blood IL-6
|
0.69 pg/mL
STANDARD_DEVIATION 0.31 • n=5 Participants
|
0.80 pg/mL
STANDARD_DEVIATION 0.79 • n=7 Participants
|
0.75 pg/mL
STANDARD_DEVIATION 0.59 • n=5 Participants
|
PRIMARY outcome
Timeframe: samples collected at baseline, immediately post exposurePopulation: Blood plasma was used to measure IL-6 using a commercially available ELISA.
IL-6 will be measured in the plasma
Outcome measures
| Measure |
Normal Sleep (With 250 ug/m^3 PM2.5)
n=20 Plasma
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).
Normal Sleep: Participants will be allowed \~8 hour sleep opportunity the night of sleep prior to reporting to lab for a simulated firefighting session.
|
Restricted Sleep (With 250 ug/m^3 PM2.5)
n=20 Plasma
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).
Sleep Restriction: Participants will be allowed \~4 hour sleep opportunity during the restricted night of sleep prior to reporting to lab for a simulated firefighting session.
|
|---|---|---|
|
Blood Inflammation
Baseline
|
0.69 pg/mL
Standard Error 0.10
|
0.79 pg/mL
Standard Error 0.25
|
|
Blood Inflammation
POST
|
2.33 pg/mL
Standard Error 0.33
|
1.63 pg/mL
Standard Error 0.25
|
SECONDARY outcome
Timeframe: samples collected at baseline, immediately post exposurePentraxin-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.
Outcome measures
| Measure |
Normal Sleep (With 250 ug/m^3 PM2.5)
n=10 Participants
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).
Normal Sleep: Participants will be allowed \~8 hour sleep opportunity the night of sleep prior to reporting to lab for a simulated firefighting session.
|
Restricted Sleep (With 250 ug/m^3 PM2.5)
n=10 Participants
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).
Sleep Restriction: Participants will be allowed \~4 hour sleep opportunity during the restricted night of sleep prior to reporting to lab for a simulated firefighting session.
|
|---|---|---|
|
Exhaled Breath Condensate Pentraxin-3
PRE
|
0.97 ng/mL
Standard Deviation 0.04
|
0.95 ng/mL
Standard Deviation 0.02
|
|
Exhaled Breath Condensate Pentraxin-3
POST
|
0.96 ng/mL
Standard Deviation 0.02
|
0.96 ng/mL
Standard Deviation 0.03
|
Adverse Events
Normal Sleep (With 250 ug/m^3 PM2.5)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Restricted Sleep (With 250 ug/m^3 PM2.5)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place