Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT05697328
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2022-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Barotrauma in Hyperbaric Oxygen Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001469', 'term': 'Barotrauma'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054199', 'term': 'Pseudoephedrine'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double-blind placebo control'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized double-blind placebo control study design (enrollment ratio 1:1)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2022-12-26', 'studyFirstSubmitQcDate': '2023-01-16', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare changes in self-reported ear pain during hyperbaric oxygen therapy', 'timeFrame': '45-60 minutes', 'description': 'Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy'}], 'secondaryOutcomes': [{'measure': 'Incidence of completed compression', 'timeFrame': '1 minute', 'description': 'Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyperbaric oxygen therapy'], 'conditions': ['Barotrauma']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to study whether the use of pseudoephedrine can help prevent middle ear trauma during HBOT. Pseudoephedrine is an approved drug that is used for temporary relief of nasal or sinus pain and pressure.', 'detailedDescription': "Subjects will be asked to take a pill (pseudoephedrine or placebo) between 45 and 120 minutes before hyperbaric oxygen therapy. Subjects' ears will be examined before and after therapy and be asked to assess ear pain. There will be no further tests or procedures after completion of therapy session and ear examinations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New patient requiring HBOT (either inpatient or outpatient)\n* Age greater than or equal to 18 years and less than 80 years\n* Fluent in English\n* Full decision capacity\n* Able and medically cleared to swallow a pill\n\nExclusion Criteria:\n\n* Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: Central Retinal Arterial Occlusion, Carbon Monoxide, Air Gas Embolism)\n* Contraindication to pseudoephedrine (monoamine oxidase inhibitors (MAOI) use, pregnancy, glaucoma, heart disease, allergy to drug class)\n* Systolic Blood Pressure \\>160\n* Diastolic Blood Pressure \\> 90\n* Heart Rate \\>100\n* Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.\n* Prisoner\n* Intubated\n* Unable to swallow oral medications'}, 'identificationModule': {'nctId': 'NCT05697328', 'acronym': 'HBOT', 'briefTitle': 'Barotrauma in Hyperbaric Oxygen Therapy', 'organization': {'class': 'OTHER', 'fullName': 'John Muir Health'}, 'officialTitle': 'Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy', 'orgStudyIdInfo': {'id': '22-10-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pseudoephedrine', 'description': 'over the counter pseudoephedrine', 'interventionNames': ['Drug: Pseudoephedrine Pill']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'pharmacy created placebo capsule', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pseudoephedrine Pill', 'type': 'DRUG', 'otherNames': ['Sudafed'], 'description': 'One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy', 'armGroupLabels': ['Pseudoephedrine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacinta Showers, RN', 'role': 'CONTACT', 'email': 'jacinta.showers@johnmuirhealth.com', 'phone': '9259473212'}, {'name': 'Todd Kessinger, MD', 'role': 'CONTACT', 'email': 'todd.kessinger_MD@johnmuirhealth.com', 'phone': '9259473212'}, {'name': 'Jacinta Showers, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Todd Kessinger, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'John Muir Health', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}], 'centralContacts': [{'name': 'Jacinta Showers, RN', 'role': 'CONTACT', 'email': 'jacinta.showers@johnmuirhealth.com', 'phone': '9259473212'}, {'name': 'Todd Kessinger, MD, MD', 'role': 'CONTACT', 'email': 'todd.kessinger_MD@johnmuirhealth.com', 'phone': '9259473212'}], 'overallOfficials': [{'name': 'Jacinta Showers, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'John Muir Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John Muir Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jacinta Showers', 'investigatorAffiliation': 'John Muir Health'}}}}