Trial · NCT01306968

Hyperbaric Oxygen Therapy (HBO2) for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (mTBI)

NCT01306968, Phase 2, Completed, U.S. Army Medical Research and Development Command; results first posted 2014-09-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Hyperbaric Oxygen Therapy (HBO2) for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (mTBI). Trials, record NCT01306968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01306968

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Hyperbaric Oxygen Therapy (HBO2) for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (mTBI)
NCT number: NCT01306968
Status: Completed
Phases: Phase 2
Enrollment: 79 participants, actual
Lead sponsor: U.S. Army Medical Research and Development Command
Conditions: Post-concussive Symptoms, Traumatic Brain Injury
Interventions: hyperbaric oxygen, sham hyperbaric air
First posted: 2011-03-02
Last updated: 2014-09-05
Results first posted: 2014-09-05

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2	The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.
Primary	Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat	Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2	Means for the change from baseline to follow-up visit 2
Primary	Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population	Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2	The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.
Primary	Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population	Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2	The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2	Intent to treat population: All randomized participants were included in the intention-to-treat analysis.	units on a scale	MEAN
PRIMARY	Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat	Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2	Intent to treat population: All randomized participants were included in the intention-to-treat analysis	units on a scale	MEAN
PRIMARY	Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population	Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2	Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.	units on a scale	MEAN
PRIMARY	Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population	Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2	Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	PTSD With no History of TBI	RPQ-3	3.5	Standard Deviation 3.21	units on a scale
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	Standard TBI Care	RPQ-3	5.1	Standard Deviation 2.81	units on a scale
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	HBO2 Group	RPQ-3	4.2	Standard Deviation 3.00	units on a scale
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	Sham Group	RPQ-3	3.5	Standard Deviation 3.25	units on a scale
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	PTSD With no History of TBI	RPQ-13	19.7	Standard Deviation 13.06	units on a scale
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	Standard TBI Care	RPQ-13	25.5	Standard Deviation 13.93	units on a scale
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	HBO2 Group	RPQ-13	22.5	Standard Deviation 12.35	units on a scale
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	Sham Group	RPQ-13	20.7	Standard Deviation 12.82	units on a scale
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	PTSD With no History of TBI	Total RPQ	23.2	Standard Deviation 16.04	units on a scale
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat	Standard TBI Care	Total RPQ	30.6	Standard Deviation 16.08	units on a scale

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PTSD With no History of TBI	7
Overall Study	STARTED	Standard TBI Care	23
Overall Study	STARTED	HBO2 Group	24
Overall Study	STARTED	Sham Group	25
Overall Study	COMPLETED	PTSD With no History of TBI	6
Overall Study	COMPLETED	Standard TBI Care	20
Overall Study	COMPLETED	HBO2 Group	23
Overall Study	COMPLETED	Sham Group	21
Overall Study	NOT COMPLETED	PTSD With no History of TBI	1
Overall Study	NOT COMPLETED	Standard TBI Care	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events36

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
other	mild ear pain	Ear and labyrinth disorders	PTSD With no History of TBI	0	0	0
other	mild ear pain	Ear and labyrinth disorders	Standard TBI Care	0	0	0
other	mild ear pain	Ear and labyrinth disorders	HBO2 Group	1	24	1
other	mild ear pain	Ear and labyrinth disorders	Sham Group	1	23	1
other	Tooth pain	General disorders	PTSD With no History of TBI	0	0	0
other	Tooth pain	General disorders	Standard TBI Care	0	0	0
other	Tooth pain	General disorders	HBO2 Group	1	24	1
other	Tooth pain	General disorders	Sham Group	0	23	0
other	Inner ear barotrauma	Ear and labyrinth disorders	PTSD With no History of TBI	0	0	0
other	Inner ear barotrauma	Ear and labyrinth disorders	Standard TBI Care	0	0	0

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PTSD With no History of TBI
Total, all-cause mortality	Standard TBI Care
Total, all-cause mortality	HBO2 Group
Total, all-cause mortality	Sham Group
Total, other adverse events	PTSD With no History of TBI	0	0
Total, other adverse events	Standard TBI Care	0	0
Total, other adverse events	HBO2 Group	8	24
Total, other adverse events	Sham Group	6	23
Total, serious adverse events	PTSD With no History of TBI	0	0
Total, serious adverse events	Standard TBI Care	0	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25401463	DERIVED	PubMed
31394602	DERIVED	PubMed
31394603	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01306968

GET https://conductscience.org/api/trials/v1/NCT01306968/results?page=2

API reference For AI assistants