N/A N=10 Randomized Basic Science

Circadian Rhythm Disruption Effects on Smoke Inhalation

Inflammation · Sleep Deprivation · Circadian Rhythm Sleep Disorder, Shift Work Type · Smoke Inhalation

Bottom Line

View on ClinicalTrials.gov: NCT04955431 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: Blood Inflammation — 0.69; 0.79; 2.33; 1.63 pg/mL — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sleep Restriction (Behavioral); Normal Sleep (Behavioral)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: University of Montana
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Blood Inflammation	0.69; 0.79; 2.33; 1.63	<0.05 sig
SECONDARY Exhaled Breath Condensate Pentraxin-3	0.97; 0.95; 0.96; 0.96	>0.05

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. 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.

Eligibility Criteria

Inclusion Criteria

Healthy
Male
18 - 44 years of age

Exclusion Criteria

Preexisting cardiometabolic and/or pulmonary diseases
Preexisting sleep disorder
Smoking (current or within last year)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04955431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.