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 — DRUGThis 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 InspirateParticipants 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 AirParticipants 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
- Timothy D Mickleborough, PhD812-855-0753
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Multidisciplinary Engineering and Sciences Hall (MESH) | Bloomington | Indiana | 47405 | Timothy D Mickleborough, PhD (PRINCIPAL_INVESTIGATOR) |
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