The Role of Heliox in Respiratory Control

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Indiana University
Study ID
NCT07424014
Phase
PHASE4
Status
Recruiting

Conditions

  • Work of Breathing

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Heliox inspirate — DRUG
    This intervention corresponds to Arm 1 titled "room air and heliox inspirate". This corresponds with the first phase/period of this study.

Study Details

Warfighters are frequently exposed to environments and life-support systems that increase breathing resistance and the work of breathing (WOB), such as aircraft on-board oxygen generation systems and underwater breathing apparatuses. Elevated WOB increases the perception of breathing difficulty (dyspnea) and has been associated with impaired cognitive performance, including slower reaction time and reduced accuracy during attention-demanding tasks. These effects are particularly concerning in operational settings that require rapid decision-making and precise motor responses. Despite growing recognition of this issue, critical gaps remain regarding strategies to mitigate the perceptual and cognitive consequences of elevated inspiratory resistance, especially under realistic operational stressors. The objective of this study is to determine whether reducing mechanical WOB alters breathing perception and cognitive performance during inspiratory resistance. Participants will breathe either normal-density air or a low-density helium-oxygen gas mixture (heliox) to determine whether reducing mechanical WOB lowers perceived breathing effort and improves cognitive function.

Key Dates

Start date
Feb 3, 2026
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Room Air, then Heliox Inspirate
    Participants will complete 2 full length breathing tasks, one under each condition. The order of condition exposure will be assigned via randomization.
  • Active Comparator: Heliox Inspirate, then Room Air
    Participants will complete 2 full length breathing tasks, one under each condition. The order of condition exposure will be assigned via randomization.

Primary Outcome Measure

Change in Stroop Color-Word Test Time Performance [ Time Frame: Before and after each Day 1 breathing task (approximately 60 minutes in duration) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Multidisciplinary Engineering and Sciences Hall (MESH)BloomingtonIndiana47405
Scott M Clarke
812-856-3244
Zachary J Schalder, PhD
812-855-6953
Timothy D Mickleborough, PhD (PRINCIPAL_INVESTIGATOR)

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