The Role of Heliox in Respiratory Control
NCT07424014, Phase 4, Recruiting, Indiana University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Role of Heliox in Respiratory Control | ClinicalTrials.gov |
| NCT number | NCT07424014 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 15 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Indiana University | ClinicalTrials.gov |
| Conditions | Work of Breathing | ClinicalTrials.gov |
| Interventions | Heliox inspirate | ClinicalTrials.gov |
| First posted | 2026-02-20 | ClinicalTrials.gov |
| Last updated | 2026-03-12 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Stroop Color-Word Test Time Performance | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | Time performance on the Stroop Color-Word Test (min:sec) will be measured every 10 minutes during each breathing task. | ClinicalTrials.gov |
| Primary | Change in Stroop Color-Word Test Error Performance | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | The number of errors on the Stroop Color-Word Test will be measured will be measured every 10 minutes during each breathing task. | ClinicalTrials.gov |
| Primary | Change in Perception of Dyspnea Intensity | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | Participants will rate perception of dyspnea (breathing) intensity on a visual analog scale (VAS) every 5 minutes during each breathing task. The participant will draw a vertical marker line on a horizontal line (100mm),indicating their breathing perception from "not noticeable" (0mm) to "maximal imaginable intensity" (100mm). | ClinicalTrials.gov |
| Primary | Change in Perception of Dyspnea Unpleasantness | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | Participants will rate perception of dyspnea (breathing) unpleasantness on a visual analog scale (VAS) every 5 minutes during each breathing task. The participant will draw a vertical marker line on a horizontal line(100mm), indicating their breathing perception from "not unpleasant"(0mm) to "maximal imaginable unpleasantness" (100mm). | ClinicalTrials.gov |
| Secondary | Change in Work of Breathing - Esophageal Pressure | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | Heliox-induced reduction in WOB will be summarized by pre- and post-values of pressure (unit: cmH2O) via esophageal balloon pressures during the heliox condition. | ClinicalTrials.gov |
| Secondary | Change in Work of Breathing - Mouth Pressure | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | Heliox-induced reduction in WOB will be summarized by pre- and post-values of pressure (unit: cmH2O) via esophageal balloon pressures, mouth pressure, and dynamic lung volumes during the heliox condition. | ClinicalTrials.gov |
| Secondary | Change in Work of Breathing - Dynamic Lung Volume | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | Heliox-induced reduction in WOB will be summarized by pre- and post-values of pressure (unit: cmH2O) via dynamic lung volumes during the heliox condition. | ClinicalTrials.gov |
| Secondary | Change in Cerebral Blood Velocity | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | Bilateral transcranial Doppler Ultrasound will be used to continuously measure middle and posterior cerebral artery blood velocity during each breathing task. The ultrasound transducers will be placed on both sides of the head at the temporal windows and the positions will be fixed using a transducer holder. | ClinicalTrials.gov |
| Secondary | Change in Cerebral Blood Oxygen Kinetics | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | Oxyhemoglobin and deoxyhemoglobin (uptake/extraction, uM) will be measured continuously via near-infrared spectroscopy (NIRS) of the pre-frontal cortex during each breathing task. | ClinicalTrials.gov |
| Secondary | Change in Heart Rate | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | Heart Rate will be measured continuously during each breathing task by 3-lead electrocardiograph (ECG). | ClinicalTrials.gov |
| Secondary | Change in Blood Pressure - Finger Photoplethysmography | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | Blood pressure will be measured continuously during each breathing task via finger photoplethysmography. | ClinicalTrials.gov |
| Secondary | Change in Blood Pressure - Brachial Artery | Before and after each Day 1 breathing task (approximately 60 minutes in duration) | Blood pressure will be measured every 10 minutes during each breathing task via a standard blood pressure cuff and auscultation of the brachial artery. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)