Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581003
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Hyperbaric Oxygen Treatment for Veterans with Traumatic Brain Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hyperbaric Oxygen Treatment for Veterans with Traumatic Brain Injury
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this blinded adaptive randomized placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active military The main questions it aims to answer are
Does Hyperbaric Oxygen Therapy HBOT reduce neurobehavioral symptoms
How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms
Does HBOT reduce posttraumatic stress disorder PTSD symptoms
Research will compare HBOT therapy to a placebo condition to see if HBOT works to treat neurobehavioral symptoms The placebo condition is a chamber that remains unpressurized and has 21 oxygen
Participants will
1 Complete baseline assessments to determine eligibility
2 Attend 40 sessions of HBOT or placebo normal air within 12 weeks
3 Complete questionnaires and interviews throughout the course of the study
4 Complete a 2-week post treatment visit
Does Hyperbaric Oxygen Therapy HBOT reduce neurobehavioral symptoms
How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms
Does HBOT reduce posttraumatic stress disorder PTSD symptoms
Research will compare HBOT therapy to a placebo condition to see if HBOT works to treat neurobehavioral symptoms The placebo condition is a chamber that remains unpressurized and has 21 oxygen
Participants will
1 Complete baseline assessments to determine eligibility
2 Attend 40 sessions of HBOT or placebo normal air within 12 weeks
3 Complete questionnaires and interviews throughout the course of the study
4 Complete a 2-week post treatment visit
Detailed Description:
Participants who consent to the study will undergo a comprehensive baseline assessment in two sessions
Baseline A This visit will involve questions about the participants brain injury and relevant medical history and surveys to learn about symptoms related to the participants mood stress sleep pain behaviors eg drug and alcohol use and life satisfaction Some surveys may be administered via an interview or as an electronic survey After Baseline A assessments are completed the investigators will determine if the participant meets the initial criteria to continue participation
Baseline B During this in-person visit the investigators will have the participant do some thinking exercises by asking himher to remember words make decisions about shapes draw and remember figures and other similar tasks The investigators will also draw 30-mL of blood from the participants arm to detect inflammation and a brief physical exam eg vision test breathing functioning heart rate The participant will have a chance complete optional procedure described below After Baseline B the investigators will determine if the participant is eligible to continue their participation If the participant is eligible the next stage is Randomization to treatment If the participant is not eligible study participation will be over
Randomization The participant will be randomized to either HBOT chamber pressurized to 2 ATA with 100 oxygen or to a placebo condition chamber that remains unpressurized and has 21 oxygen The participant will not get to choose the treatment The participant nor the PI will know which treatment is received
HBOT or Placebo Dives Both conditions will take place in a chamber and each treatment session is called a dive The participant will then complete 40 HBOT or placebo dives in 12 weeks at USF Every dive the investigators will record the participants blood pressure respiration breathing rate and pulse If the participant is diabetic the investigators will also record their glucose levels Then the participant will change into a medical gown and lay down in a clear chamber for their dive The participant will be in the chamber for about 72 minutes Every 5 dives the participant will complete self-report measures about how they are currently feeling While the FDA has approved HBOT for some conditions it is considered an experimental therapy for TBI The entire visit should last about 90 minutes from self-report measures to getting dressed The participants regular medical treatment will not change if they take part in the research
Mid-treatment Assessments After the 20th dive is complete the investigators will ask the participant to complete a mid-treatment assessment visit The investigators do this to monitor how the participant are feeling and thinking During this visit the participant will complete many of the same self-report measures and interviews as they did during the baseline visits The participant will also give another 30-mL of blood at this mid-treatment visit
Posttreatment Assessments After the 40 dives are complete the investigators will ask the participant to complete 1 post-treatment visit at approximately 2 weeks after the last dive The investigators do this to continue monitoring how the participant is feeling and thinking During this assessment the participant will complete many of the same self-report measures and interviews as heshe did during the baseline visits and the mid-treatment visit The participant will also give another 30-mL of blood After the participant completes the Posttreatments assessments the investigators will tell himher which treatment heshe was randomized to receive If the participant was randomized to the Placebo treatment heshe will be given the opportunity to receive the actual treatment
Baseline A This visit will involve questions about the participants brain injury and relevant medical history and surveys to learn about symptoms related to the participants mood stress sleep pain behaviors eg drug and alcohol use and life satisfaction Some surveys may be administered via an interview or as an electronic survey After Baseline A assessments are completed the investigators will determine if the participant meets the initial criteria to continue participation
Baseline B During this in-person visit the investigators will have the participant do some thinking exercises by asking himher to remember words make decisions about shapes draw and remember figures and other similar tasks The investigators will also draw 30-mL of blood from the participants arm to detect inflammation and a brief physical exam eg vision test breathing functioning heart rate The participant will have a chance complete optional procedure described below After Baseline B the investigators will determine if the participant is eligible to continue their participation If the participant is eligible the next stage is Randomization to treatment If the participant is not eligible study participation will be over
Randomization The participant will be randomized to either HBOT chamber pressurized to 2 ATA with 100 oxygen or to a placebo condition chamber that remains unpressurized and has 21 oxygen The participant will not get to choose the treatment The participant nor the PI will know which treatment is received
HBOT or Placebo Dives Both conditions will take place in a chamber and each treatment session is called a dive The participant will then complete 40 HBOT or placebo dives in 12 weeks at USF Every dive the investigators will record the participants blood pressure respiration breathing rate and pulse If the participant is diabetic the investigators will also record their glucose levels Then the participant will change into a medical gown and lay down in a clear chamber for their dive The participant will be in the chamber for about 72 minutes Every 5 dives the participant will complete self-report measures about how they are currently feeling While the FDA has approved HBOT for some conditions it is considered an experimental therapy for TBI The entire visit should last about 90 minutes from self-report measures to getting dressed The participants regular medical treatment will not change if they take part in the research
Mid-treatment Assessments After the 20th dive is complete the investigators will ask the participant to complete a mid-treatment assessment visit The investigators do this to monitor how the participant are feeling and thinking During this visit the participant will complete many of the same self-report measures and interviews as they did during the baseline visits The participant will also give another 30-mL of blood at this mid-treatment visit
Posttreatment Assessments After the 40 dives are complete the investigators will ask the participant to complete 1 post-treatment visit at approximately 2 weeks after the last dive The investigators do this to continue monitoring how the participant is feeling and thinking During this assessment the participant will complete many of the same self-report measures and interviews as heshe did during the baseline visits and the mid-treatment visit The participant will also give another 30-mL of blood After the participant completes the Posttreatments assessments the investigators will tell himher which treatment heshe was randomized to receive If the participant was randomized to the Placebo treatment heshe will be given the opportunity to receive the actual treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None