Comparison · NCT01611194-sae
HBO2 at 1.5 Atomspheres Absolute (ATA) vs Sham Control (1.2 Atomspheres): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. HBO2 at 1.5 Atomspheres Absolute (ATA) vs Sham Control (1.2 Atomspheres): serious adverse events. Trial comparisons, record NCT01611194-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01611194-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.139 | 0.0608 | 0.287 | wilson | |
| Risk in group 2 | 0.0857 | 0.0296 | 0.224 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0532 | -0.105 | 0.211 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.62 | 0.419 | 6.27 | log | |
| Odds ratio, group 1 over group 2 | 1.72 | 0.378 | 7.82 | log | |
| Number needed to harm, for one more participant with a serious adverse event on HBO2 at 1.5 Atomspheres Absolute (ATA) than on Sham Control (1.2 Atomspheres) | 18.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: sham.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | HBO2 at 1.5 Atomspheres Absolute (ATA) | Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.~Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week. | 5 | 36 | EG000 |
| Group 2 | Sham Control (1.2 Atomspheres) | Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).~Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs). | 3 | 35 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016.
Source ClinicalTrials.gov
Trial
- Title
- mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms
- NCT number
- NCT01611194
- Phases
- PHASE2
- Conditions
- Traumatic Brain Injury With Brief Loss of Consciousness, Post-Concussion Syndrome
- Interventions
- Hyperbaric oxygen (HBO2) at 1.5 atms, Sham control 1.2 atms
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Results first posted
- 2018-11-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01611194?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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