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Restricted Sleep (with 250 ug/m^3 PM2.5) for Sleep Deprivation

N/A
Waitlist Available
Led By John C Quindry, PhD
Research Sponsored by University of Montana
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sampled collected every 6 hours for 24 hours prior to exposure
Awards & highlights

Study 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.

Eligible Conditions
  • Sleep Deprivation
  • Inflammation
  • Shift Work Sleep Disorder
  • Smoke Inhalation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~samples collected immediately post exposure will be compared to pre-exposure
This trial's timeline: 3 weeks for screening, Varies for treatment, and samples collected immediately post exposure will be compared to pre-exposure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Inflammation
Secondary outcome measures
Exhaled Breath Condensate
Other outcome measures
Circadian clock gene expression disruption

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Restricted Sleep (with 250 ug/m^3 PM2.5)Experimental Treatment1 Intervention
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).
Group II: Normal Sleep (with 250 ug/m^3 PM2.5)Placebo Group1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Restriction
2016
N/A
~470

Find a Location

Who is running the clinical trial?

University of MontanaLead Sponsor
23 Previous Clinical Trials
3,544 Total Patients Enrolled
University of Nevada, Las VegasOTHER
66 Previous Clinical Trials
13,789 Total Patients Enrolled
John C Quindry, PhDPrincipal InvestigatorUniversity of Montana

Frequently Asked Questions

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~3 spots leftby Apr 2025