Hyperbaric Oxygen Effects on Persistent Post-concussive Symptoms

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 28, 2022

Primary Completion Date

August 30, 2025

Study Completion Date

September 30, 2025

Conditions
Persistent Post-concussive SyndromeConcussion Post Syndrome
Interventions
DRUG

Hyperbaric oxygen at 1.5 ATA

Hyperbaric oxygen (HBO2) at 1.5 ATA (active) group (hyperbaric oxygen-chamber compressed to 1.5 atmosphere absolute and breathing \>99.9% oxygen). Each participant should complete 40 sessions, one session per day, five per week over the course of 3 months.

DRUG

Sham treatment

"Sham treatment includes pressurizing the chamber to 1.2 ATA with air for 5 minutes with noise of circulating air, return the chamber to 1.0 ATA after 5-7 minutes and maintain it at that pressure for until the end of the treatment, with noise of circulating air. Internal control knobs will be concealed. Participants will be instructed to undergo intermittent ear clearing technique during the initial 5 minutes of descent"

Trial Locations (1)

58103

Essentia Health, Fargo

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

University of North Dakota

OTHER

collaborator

Dakota Medical Foundation

UNKNOWN

collaborator

The Swanson Foundation

UNKNOWN

collaborator

State of North Dakota

UNKNOWN

lead

Essentia Health

OTHER