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The Role of Heliox in Respiratory Control

StatusRecruiting
PhasePhase 4
Started2026-02-03
View on ClinicalTrials.gov ↗

Amendment history

2026-03-10
Active, Not Recruiting→Recruiting Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Trial statusActive, Not Recruiting→Recruiting
PhaseEarly Phase 1→Phase 4
Primary completion date2028-05-31→2027-05-31
Completion date2028-10-01→2027-05-31
Start date2025-09-17→2026-02-03
Enrollment target45→15
Study arms3→2
InterventionsAuditory feedback (music distraction and increased ventilation feedback) (Other), Heliox inspirate (Drug), Hot and cold environmental…→Heliox inspirate (Drug)
Secondary endpoints5 to 8 entries
Heliox-Induced ChangesChange in Work of Breathing - Esophageal Pressure ChangesChange in Work of Breathing - Mouth Pressure Change in Work of Breathing - Dynamic Lung Volume Change in Cerebral Blood Velocity ChangesChange in Cerebral Blood Oxygen Kinetics ChangesChange in CardiovascularHeart ResponsesRate ChangesChange in AutonomicBlood ActivityPressure - Finger Photoplethysmography Change in Blood Pressure - Brachial Artery
Study description-3,464 characters
Many Warfighters are exposed to environmental conditions that increase breathing resistance, which in turn increases the work of breathing (WOB). Life support systems, such as aircraft on-board oxygen delivery systems (OBOGs) and self-contained underwater breathing apparatuses (SCUBA), challenge ope [...] Increases in the WOB intensify the sensory and emotional per [...] arfighters that experience elevated inspiratory resistance. ItThis isstudy notwill knowninvestigate whether: 1) reducing the WOB during inspiratory resistance can lower breathing perception and restore cognitive function, 2) altering audito [...] [...]
Study sitesdetails revised at 1 of 1 site
Study title-69 characters
OptimizingThe Mind-BodyRole Interactionsof Heliox in Respiratory Control During Operationally Relevant Environmental Stressors
2026-02-19
Original filing
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.
Trial Details
NCT Number NCT07424014
Lead Sponsor Indiana University
Collaborators: United States Department of Defense
Conditions Work of Breathing
Enrollment 15 participants
Start Date 2026-02-03
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-12