BarotraumaHBOTNCT05697328
Barotrauma in Hyperbaric Oxygen Therapy
A study testing Pseudoephedrine Pill in people with Barotrauma, run by John Muir Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barotrauma
- What is being tested?
- Pseudoephedrine Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New patient requiring HBOT (either inpatient or outpatient)
- Age greater than or equal to 18 years and less than 80 years
- Fluent in English
- Full decision capacity
- Able and medically cleared to swallow a pill
Who cannot join
- Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: Central Retinal Arterial Occlusion, Carbon Monoxide, Air Gas Embolism)
- Contraindication to pseudoephedrine (monoamine oxidase inhibitors (MAOI) use, pregnancy, glaucoma, heart disease, allergy to drug class)
- Systolic Blood Pressure >160
- Diastolic Blood Pressure > 90
- Heart Rate >100
- Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
Show all 9Show fewer
- Prisoner
- Intubated
- Unable to swallow oral medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
John Muir Health
Walnut Creek, California, 94598
Jacinta Showers, RN, 9259473212, jacinta.showers@johnmuirhealth.com
Todd Kessinger, MD, 9259473212, todd.kessinger_MD@johnmuirhealth.com
About this study
Official title: Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
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.
Read the detailed description
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.
- Conditions
- Barotrauma
- Being tested
- Pseudoephedrine Pill, Placebo
- Keywords
- hyperbaric oxygen therapy
- Medical subject headings
- Barotrauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pseudoephedrine PillDrug
Also called Sudafed
One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
PlaceboDrug
One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| Pseudoephedrine | Experimental | over the counter pseudoephedrine Receives: Drug: Pseudoephedrine Pill |
| Placebo | Placebo comparator | pharmacy created placebo capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare changes in self-reported ear pain during hyperbaric oxygen therapy
Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy
Measured: 45-60 minutes
Secondary outcomes (1)
Incidence of completed compression
Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start31 Jan 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BarotraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized double-blind placebo control study design (enrollment ratio 1:1)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Muir Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacinta Showers, John Muir Health
- Investigators
- Jacinta Showers, RN, Principal investigator, John Muir Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697328
- Sponsor's protocol ID
- 22-10-01
- Acronym
- HBOT
- Status last verified
- Aug 2025
- First submitted
- 26 Dec 2022
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
- ClinicalTrials.gov ID
- NCT05697328
- Acronym / sponsor ID
- HBOT / 22-10-01
- Conditions
- Barotrauma
- Keywords
- hyperbaric oxygen therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- John Muir HealthUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized double-blind placebo control study design (enrollment ratio 1:1)
| Arm | Type | Receives |
|---|---|---|
| Pseudoephedrine | Experimental | Drug: Pseudoephedrine Pillover the counter pseudoephedrine |
| Placebo | Placebo comparator | Drug: Placebopharmacy created placebo capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- New patient requiring HBOT (either inpatient or outpatient)
- Age greater than or equal to 18 years and less than 80 years
- Fluent in English
- Full decision capacity
- Able and medically cleared to swallow a pill
Key exclusion criteria (9 listed)
- Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: Central Retinal Arterial Occlusion, Carbon Monoxide, Air Gas Embolism)
- Contraindication to pseudoephedrine (monoamine oxidase inhibitors (MAOI) use, pregnancy, glaucoma, heart disease, allergy to drug class)
- Systolic Blood Pressure >160
- Diastolic Blood Pressure > 90
- Heart Rate >100
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pseudoephedrine PillAlso: SudafedOne-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy | Drug | Pseudoephedrine |
| PlaceboOne time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy | Drug | Placebo |
Primary outcome
Compare changes in self-reported ear pain during hyperbaric oxygen therapy
Time frame: 45-60 minutes
Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy
1 secondary outcome
Incidence of completed compression
Time frame: 1 minute
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacinta Showers, RN principal investigator
John Muir Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pseudoephedrine Pill in people with Barotrauma, run by John Muir Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacinta Showers, RN (9259473212, jacinta.showers@johnmuirhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare changes in self-reported ear pain during hyperbaric oxygen therapy (time frame: 45-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025; AzTrials last refreshed its copy on 28 Oct 2026.