[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658256":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":48,"studyPopulation":41,"armGroups":49,"interventions":56,"overallOfficials":62,"centralContacts":66,"locations":72,"responsibleParty":88,"collaborators":41,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":41,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":41,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":74,"whyStopped":41,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Summit Hyperbarics and Wellness","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":41,"otherOutcomes":41},[9,13,16,19,22,25,28,31,35,38],{"measure":10,"description":11,"timeFrame":12},"Change in blood C-reactive protein (CRP) concentration","Difference in CRP concentration between baseline and completion of 40 HBOT sessions.","Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).",{"measure":14,"description":15,"timeFrame":12},"Change in blood interleukin-1 (IL-1) concentration","Difference in IL-1 concentration between baseline and completion of 40 HBOT sessions.",{"measure":17,"description":18,"timeFrame":12},"Change in blood interleukin-6 (IL-6) concentration","Difference in IL-6 concentration between baseline and completion of 40 HBOT sessions.",{"measure":20,"description":21,"timeFrame":12},"Change in blood interleukin-10 (IL-10) concentration","Difference in IL-10 concentration between baseline and completion of 40 HBOT sessions.",{"measure":23,"description":24,"timeFrame":12},"Change in blood tumor necrosis factor-alpha (TNF-α) concentration","Difference in TNF-α concentration between baseline and completion of 40 HBOT sessions.",{"measure":26,"description":27,"timeFrame":12},"Change in blood brain-derived neurotrophic factor (BDNF) concentration","Difference in BDNF concentration between baseline and completion of 40 HBOT sessions.",{"measure":29,"description":30,"timeFrame":12},"Change in blood neurofilament light chain (NfL) concentration","Difference in NfL concentration between baseline and completion of 40 HBOT sessions.",{"measure":32,"description":33,"timeFrame":34},"Change in blood glial fibrillary acidic protein (GFAP) concentration","Difference in GFAP concentration between baseline and completion of 40 HBOT sessions.","Baseline and after completion of 40 HBOT sessions (approximately 4 weeks)",{"measure":36,"description":37,"timeFrame":12},"Change in blood brain-derived tau (BD-tau) concentration","Difference in BD-tau concentration between baseline and completion of 40 HBOT sessions.",{"measure":39,"description":40,"timeFrame":12},"Change in blood ubiquitin C-terminal hydrolase L1 (UCH-L1) concentration","Difference in UCH-L1 concentration between baseline and completion of 40 HBOT sessions.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"NA","SINGLE_GROUP","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE","This prospective, single-group study will evaluate changes in blood biomarkers following hyperbaric oxygen therapy (HBOT) in approximately 34 military veterans with a history of traumatic brain injury (TBI) and persistent post-concussive symptoms (PCS). The primary objective is to assess changes from baseline to completion of treatment in biomarkers associated with inflammation (CRP, IL-1, IL-6, IL-10, and TNF-α), neurotrophic activity (BDNF), and neuronal injury (NfL, GFAP, BD-tau, and UCH-L1). An exploratory objective is to assess whether biomarker changes differ between participants with and without comorbid post-traumatic stress disorder (PTSD).\n\nBefore treatment, participants will undergo medical and behavioral health evaluations to determine their suitability for HBOT. Eligible participants will complete a baseline blood draw for biomarker analysis and standard laboratory testing. Demographic, military service, and relevant clinical information will also be collected.\n\nAll participants will receive 40 HBOT sessions in a multiplace chamber at 2.0 atmospheres absolute (ATA). During each session, participants will breathe 100% oxygen for two 30-minute periods separated by a 5-minute air break. Sessions will be scheduled twice daily, Monday through Friday, with at least four hours between sessions. Blood collection and standard laboratory testing will be repeated after the 40-session protocol.\n\nThe study will use a pretest-posttest design without randomization or a control group. Within-participant biomarker changes will be evaluated using paired statistical tests, with adjustments for multiple comparisons in the primary biomarker analyses. Comparisons by comorbid PTSD status and associations between biomarker changes and clinical outcomes will be exploratory. Because all participants receive HBOT, observed changes cannot be attributed to HBOT alone.",[50],{"label":51,"type":52,"description":53,"interventionNames":54},"Hyperbaric Oxygen Therapy (HBOT) - 40 Sessions","EXPERIMENTAL","Participants in this arm will receive 40 hyperbaric oxygen therapy (HBOT) sessions in a multiplace chamber at 2.0 atmospheres absolute (ATA). Each session will include two 30-minute periods of breathing 100% oxygen, separated by a 5-minute air break. Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions.",[55],"Drug: Hyperbaric Oxygen Therapy (HBOT)",[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":41},"DRUG","Hyperbaric Oxygen Therapy (HBOT)","Hyperbaric Oxygen Therapy (HBOT): Participants will complete 40 sessions at 2.0 atmospheres absolute (ATA). Each session includes two 30-minute periods of breathing 100% oxygen, separated by a 5-minute air break. Sessions are generally scheduled twice daily with at least four hours between them.",[51],[63],{"name":64,"affiliation":5,"role":65},"Steve Wyman, MD","PRINCIPAL_INVESTIGATOR",[67],{"name":68,"role":69,"phone":70,"phoneExt":41,"email":71},"Troy Nickel, Ph.D.","CONTACT","208-813-9541","tnickel@shwidaho.org",[73],{"facility":5,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"RECRUITING","Boise","Idaho","83716","United States","US",{"type":81,"coordinates":82},"Point",[83,84],-116.20345,43.6135,{"lat":84,"lon":83},[87],{"name":68,"role":69,"phone":70,"phoneExt":41,"email":71},{"type":65,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Steve Wyman","Medical Director","100658256","phase-2-hyperbaric-oxygen-therapy-for-veterans-with-tbi-and-pcs-a-biomarker-study-100658256",false,"NCT07849465","Hyperbaric Oxygen Therapy for Veterans With TBI and PCS: A Biomarker Study","Neuroinflammatory and Neuroinjury Biomarker Dynamics Following Hyperbaric Oxygen Therapy in Veterans With Traumatic Brain Injury and Persistent Post-Concussive Symptoms","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Veteran status\n3. Clinically diagnosed with a TBI by a qualified healthcare professional.\n4. Participants with comorbid post-traumatic stress disorder (PTSD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria by a qualified and trained professional, are eligible for enrollment but are not required for study participation.\n\n4\\. The participant is willing and able to read, understand, and sign an informed consent. Additionally, the participant has clear consciousness and the ability to express self-feelings independently.\n\n6\\. Completed psychological measurements (pre-study screening requirement) 7. Presence of clinically significant cognitive and\u002For PCS symptoms resulting in impairment in occupational, social, and other important areas of functioning, as determined by clinical evaluation.\n\n8\\. Sexually active female participants of childbearing potential and sexually active male participants with female partners of childbearing potential must agree to use an acceptable method of contraception for the duration of the study and for 30 days following the final HBOT session.\n\n9\\. Stability on any prescribed psychoactive medications and\u002For other chronic medical medications. Stability is defined as no significant changes in type of dosage within the previous 4-5 weeks, to minimize confounding effects on study outcomes and ensure participant safety.\n\nExclusion Criteria:\n\n1. Untreated pneumothorax\n2. History of spontaneous pneumothorax\n3. Asymptomatic pulmonary lesions on chest x-ray\n4. Uncontrollable high fever (greater than 39C)\n5. History of chest or ear surgery\n6. Congenital spherocytosis\n7. Any anemia or blood disorder\n8. Any convulsive disorder\n9. History of optic neuritis or sudden blindness\n10. Middle ear infection\n11. Diabetes mellitus (insulin therapy)\n12. The participant is pregnant or lactating\n13. Nicotine use\u002Fsubstance use\u002Faddiction\n14. Acute Hypoglycemia\n15. Diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Emphysema\n16. Presenting with symptoms of cough, congestion, vomiting, diarrhea, or open wounds.\n17. Active malignancy\n18. Current manic, delusional, or psychotic episodes\n19. Serious\u002Fcurrent suicidal ideations\n20. Severe or unstable physical disorders or major cognitive deficits\n21. Inability to attend scheduled clinic visits or comply with study protocols.\n22. Treated with HBOT for any reason prior to study enrollment.\n23. Non-English speakers\n24. History of retinal repair, including laser photocoagulation or retinal detachment surgery.\n25. History of middle ear surgery, including tympanoplasty, mastoidectomy, or pressure equalization tube placement.\n26. Age greater than 75 years.\n27. Use of any of the following medications during the study period: Anti-metabolites (e.g., methotrexate, azathioprine); Chemotherapeutic agents (e.g., cyclophosphamide, cisplatin); Mafenide acetate e.g., Sulfamylon); Disulfiram (e.g, Antabuse); Peripheral vasodilators known to interact with oxygen exposure (e.g., nitroglycerin); and Antibacterial drugs with known HBOT interaction risks.\n28. Recent vaccination (≤ 1 week), or underlying inflammatory conditions\n29. Use of systemic corticosteroids or immunomodulatory therapies\n30. Active or recent infection requiring antibiotics.\n31. Significant renal or hepatic impairment.\n32. Regular participation in intense physical training or exercise programs (Defined as endurance events (e.g., triathlons, marathons, ultramarathons, Ironman-level training) or high-intensity interval training (HIIT) programs performed multiple times per week)\n33. Recent (within 4 weeks prior to baseline) or planned use of antioxidant supplements or high-dose vitamins (Examples include: Vitamin C (\\> 500 mg\u002Fday), Vitamin E (\\>200 IU\u002Fday), N-acetylcysteine (NAC) or other thiol-based antioxidants, Alpha-lipoic acid, high-dose multivitamins containing the above doses, or Omega-3 fatty acid concentrates taken specifically for antioxidant\u002Fanti-inflammatory purposes)\n34. Recent participation in other clinical trials that could affect biomarker levels.\n35. Untreated or severe sleep disorders","ALL","18 Years","75 Years",{"count":102,"type":103},34,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","The goal of this study is to examine changes in blood biomarkers following hyperbaric oxygen therapy (HBOT) in military veterans with traumatic brain injury and persistent post-concussive symptoms. The main questions it aims to answer are:\n\n1. Does HBOT produce measurable changes in inflammatory, neurotrophic, and neuronal injury biomarkers from baseline to completion of a 40-session treatment protocol in veterans with TBI and PCS?\n2. Does the presence of comorbid PTSD influence biomarker responses to HBOT among veterans with TBI and PCS?\n\nParticipants will:\n\nComplete medical and behavioral health evaluations to determine eligibility. Provide blood samples before treatment and after the final session. Receive 40 HBOT sessions at 2.0 ATA, generally two sessions per day with at least four hours between sessions.\n\nApproximately 34 veterans will participate. All participants will receive HBOT; there is no comparison group.",[109,110,111],"Traumatic Brain Injury (TBI) Patients","Post Concussive Symptoms","PTSD",[113,114,115,116,59,117,118,119],"Traumatic brain injury (TBI)","Post-concussive symptoms (PCS)","Post-traumatic stress disorder","Veterans","Blood biomarkers","Neuroinflammation","Neuronal Injury","2026-09-24",{"date":122,"type":123},"2026-09-30","ACTUAL",{"date":125,"type":103},"2026-10-01",{"date":127,"type":103},"2027-10-01",{"name":5,"class":6},1]