NCT01986205

Brief Summary

The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions. Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 6 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research. After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen sessions, then undergo the same tests at 9 months and 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
3.8 years until next milestone

Study Start

First participant enrolled

September 6, 2017

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

4.7 years

First QC Date

October 31, 2013

Last Update Submit

August 2, 2022

Conditions

Brain Injury, Chronic

Keywords

ConcussionTraumatic brain injuryHyperbaric oxygenationPost-concussion symptomsHeadacheCarbon monoxide

Outcome Measures

Primary Outcomes (1)

  • Neurobehavioral Symptom Inventory

    Participant-reported symptom rating of post-concussive symptoms

    13 weeks

Secondary Outcomes (2)

  • Neurobehavioral Symptom Inventory

    6 months

  • Incidence of myopia

    13 weeks

Study Arms (2)

Hyperbaric Oxygen

EXPERIMENTAL

100% oxygen at 1.5 atmospheres absolute for 60 minutes, 40 sessions

Combination Product: Hyperbaric Oxygen

Minimal pressure air

PLACEBO COMPARATOR

Regular air at minimal pressurization for 60 minutes, 40 sessions

Combination Product: Minimal pressure air

Interventions

Hyperbaric OxygenCOMBINATION_PRODUCT

Hyperbaric oxygen (USP oxygen \>99%) delivered in a hyperbaric chamber pressurized to 1.5 atmospheres absolute.

Also known as: HBO2, HBOT, HBO, Hyperbaric oxygen therapy
Hyperbaric Oxygen
Minimal pressure airCOMBINATION_PRODUCT

Room air delivered in a hyperbaric chamber with minimal pressurization.

Also known as: Room air
Minimal pressure air

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults, age 18-70 years, both men and women
  • Able to speak and read English as primary language
  • Able and willing to provide written informed consent for study participation.
  • Able and willing to complete outcome assessments and provide blood and urine samples as required by the study protocol.
  • Able to tolerate the chamber environment and hood placement and to equalize middle ear pressure.
  • Past history of at least one brain injury with persistent symptoms that meets all of the following criteria:
  • Brain injury of non-stroke etiology that occurred at least 6 months but no more than 10 years prior to enrollment.
  • At least 3 of the following persistent symptoms from the injury: headaches, dizziness or balance problems, blurred vision, tiredness/fatigue or sleep problems, seizures, remembering things or solving problems, managing stress or emotional upsets, controlling temper/irritability, depression, anxiety, post-traumatic stress, or ringing in the ears.
  • Normal thyroid stimulating hormone and hematocrit value greater than 35% within the previous 6 months.

You may not qualify if:

  • Contraindications to hyperbaric oxygen
  • Insulin-dependent diabetes mellitus, or diabetes mellitus that is not reasonably controlled.
  • Uncontrolled seizure disorder (participants must be on therapy and seizure-free for at least 6 months).
  • Claustrophobia precluding chamber or hood tolerance.
  • Implanted devices not cleared for hyperbaric pressurization.
  • Pregnancy or plans to become pregnant during the study participation period. Women of childbearing potential will be asked to use an acceptable form of birth control during study participation.
  • Lung disease, such as emphysema, chronic bronchitis, asthma that is not well-controlled, or bullous lung disease that raises the risk for pulmonary barotrauma due to air trapping.
  • Active malignancy, previous malignancy (except basal cell carcinoma) in the last 5 years, or any prior treatment with bleomycin (Blenoxane). Prior treatment with doxorubicin (Adriamycin) is acceptable as long follow-up echocardiography is normal.
  • Chronic disease such as heart or renal failure would raise the participant's risk of adverse events during hyperbaric oxygen.
  • Confounds to the outcome assessments
  • Inability to speak English as their primary language (English fluency required because many of the outcomes are only in available in English)
  • Instability with walking requiring more than a cane for assistance
  • Alcohol abuse, by self-report, within the last year.
  • Lifetime history of illicit drug use, by self-report, except remote (greater than one year), non-habitual use of marijuana.
  • Failed urine drug screen during study participation.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Intermountain LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Related Publications (1)

  • Churchill S, Weaver LK, Deru K, Russo AA, Handrahan D, Orrison WW Jr, Foley JF, Elwell HA. A prospective trial of hyperbaric oxygen for chronic sequelae after brain injury (HYBOBI). Undersea Hyperb Med. 2013 Mar-Apr;40(2):165-93.

    PMID: 23682548BACKGROUND

MeSH Terms

Conditions

Brain Injury, ChronicBrain ConcussionBrain Injuries, TraumaticPost-Concussion SyndromeHeadache

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesHead Injuries, ClosedWounds, NonpenetratingPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Lindell K. Weaver, MD

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director, Hyperbaric Medicine

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 18, 2013

Study Start

September 6, 2017

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations

US(2)