[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613193":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":58,"collaborators":60,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":25,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":95,"overallStatus":102,"whyStopped":25,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Blekinge Institute of Technology","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Hydrogen Gas Intervention","EXPERIMENTAL","In this arm, participants will undergo a single hyperbaric exposure breathing a gas mixture composed of 98-99% oxygen and 1-2% hydrogen (H₂) at a partial pressure of 1.75 ATA for 240 minutes. The intervention aims to evaluate whether hydrogen gas has protective effects against pulmonary oxygen toxicity. Pulmonary function tests and blood and urin sampling for oxidative stress biomarkers will be performed both before and after the exposure session. The order of intervention and control exposures is randomized and the study is conducted in a double-blind fashion.\n\nA washout period of at least two weeks will follow before the control",[13,14],"Other: Inhaled Hydrogen-Enriched Oxygen Gas","Other: Inhaled Nitrogen-Enriched Oxygen Gas",{"label":16,"type":17,"description":18,"interventionNames":19},"Nitrogen Gas Control","ACTIVE_COMPARATOR","In this arm, participants will undergo a single hyperbaric exposure breathing a gas mixture composed of 98-99% oxygen and 1-2% nitrogen (N₂) at a partial pressure of 1.75 ATA for 240 minutes. This exposure serves as the control condition and represents the standard oxygen-enriched breathing gas currently in use. Pulmonary function tests and blood and urin sampling for oxidative stress biomarkers will be performed both before and after the exposure session. Participants will be randomized to the order of exposures, and both participants and investigators will be blinded to the gas composition. A washout period of at least two weeks will follow before the intervention.",[13,14],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Inhaled Hydrogen-Enriched Oxygen Gas","Participants will inhale a gas mixture consisting of 98-99% oxygen and 1-2% hydrogen via a breathing circuit during a single hyperbaric exposure. The exposure will be conducted at a partial pressure of 1.75 ATA for 240 minutes. The intervention aims to evaluate the protective effect of hydrogen gas against pulmonary oxygen toxicity.",[9,16],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Inhaled Nitrogen-Enriched Oxygen Gas","Participants will inhale a gas mixture consisting of 98-99% oxygen and 1-2% nitrogen via a breathing circuit during a single hyperbaric exposure. The exposure will be conducted at a partial pressure of 1.75 ATA for 240 minutes. The intervention aims to evaluate the protective effect of hydrogen gas against pulmonary oxygen toxicity.",[9,16],[31,43],{"facility":5,"status":25,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":25},"Karlskrona","Blekinge County","37179","Sweden","SE",{"type":38,"coordinates":39},"Point",[40,41],15.58661,56.16156,{"lat":41,"lon":40},{"facility":44,"status":25,"city":32,"state":25,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":45,"geoPoint":47,"contacts":48},"Swedish Armed Forces Diving and Naval Medicine Centre (DNC)",{"type":38,"coordinates":46},[40,41],{"lat":41,"lon":40},[49,54],{"name":50,"role":51,"phone":52,"phoneExt":25,"email":53},"Johan Douglas, MD","CONTACT","+46","johan.a.douglas@mil.se",{"name":55,"role":51,"phone":56,"phoneExt":25,"email":57},"Oscar Plogmark, MD","+46768899938","oscar.plogmark@mil.se",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[61,63,65,67],{"name":62,"class":6},"Karolinska Institutet",{"name":64,"class":6},"Göteborg University",{"name":66,"class":6},"Lund University",{"name":68,"class":6},"Swedish Armed Forces Diving and Naval Medicine Centre","100613193","effect-of-hydrogen-gas-on-hyperbaric-oxygen-toxicity-100613193",false,"NCT07263399","Effect of Hydrogen Gas on Hyperbaric Oxygen Toxicity","Effect of Hydrogen Gas on Hyperbaric Oxygen Toxicity - A Randomized Controlled Cross-Over Trial","Inclusion Criteria:\n\n* Military divers actively serving, aged 20-64 years\n* Meeting the Swedish Armed Forces physical standards for diving\n\nExclusion Criteria:\n\n* Ongoing infection or illness that may impact pulmonary function\n* Use of alcohol or smoking cigarettes within 48 hours\n* Diving with any breathing gas within 48 hours\n* Diving with oxygen-enriched gas (100% O₂) within 2 weeks\n* Use of medications that could affect oxidative stress, lung function, or neurological status\n* Medical history of serious diving-related injuries or long-term complications",true,"ALL","20 Years","64 Years",{"count":81,"type":82},32,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this trial is to investigate whether adding a small fraction of hydrogen gas to an oxygen-enriched breathing mixture can reduce pulmonary oxygen toxicity (POT) in healthy and active divers from the Swedish Armed Forces. The main questions it aims to answer are:\n\n* Does hydrogen gas reduce oxidative stress and changes in pulmonary function associated with prolonged hyperbaric oxygen exposure?\n* What are the underlying pathophysiological mechanisms of pulmonary oxygen toxicity?\n\nResearchers will compare oxygen-enriched breathing gas with 1-2% hydrogen to oxygen-enriched gas with 1-2% nitrogen (control) to see if hydrogen provides protective effects against POT during hyperbaric exposure.\n\nParticipants will:\n\n* Complete two hyperbaric exposure sessions (hydrogen vs. nitrogen), each lasting 240 minutes at 1.75 ATA\n* Undergo pulmonary function tests and sampling of blod and urin before and after each session\n* Serve as their own controls in a double-blind, randomized, crossover study design",[88,89,90,91,92,93,94],"Oxygen Toxicity","Oxidative Stress","Hyperoxia","Hyperbaric Oxygen","Healthy Subjects (HS)","Diving Medicine","Hydrogen-oxygen Gas",[96,97,98,99,91,100,101],"Pulmonary Oxygen Toxicity","Hydrogen Gas","Diving Physiology","Lung Function","Human Study","Military Divers","NOT_YET_RECRUITING","2025-12-01",{"date":105,"type":106},"2025-12-04","ACTUAL",{"date":108,"type":82},"2026-01",{"date":110,"type":82},"2030-12",{"name":5,"class":6},2]