Clinical trial NCT04332211
Conditions: Barotrauma;Ear
Keywords: Pseudoephedrine Hyperbaric oxygen therapy prophylaxis
Sponsor: University of Maryland, Baltimore
Start date: 2021-05-01; Completion date: 2023-07-12
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atm for the treatment of various emergent medical conditions including carbon monoxide poisoning. The most commonly associated complication of HBOT is middle ear barotrauma (MEB) which occurs when the eustachian tube does not allow air to enter the middle ear space to equalize the pressure between the ambient environment and the inner ear. Patients experiencing MEB usually feel pressure or pain in their ear(s). The spectrum of symptoms ranges from sensation of ear fullness and muffled hearing to severe pain, vertigo and tympanic membrane rupture. The incidence of MEB, depending on the definition used is between 2-45%. The severe discomfort associated with MEB sometimes causes HBOT to be postponed or abandoned. Last year 27/991 treatments at our Center for Hyperbaric and Dive Medicine were aborted due to MEB. Currently there is no objective criteria for predicting which patients will experience these complications, nor is there consensus on effective prevention measures. At our facility, oxymetazoline, a topical nasal decongestant, is the standard rescue medication administered for patients that have symptoms of MEB during HBOT. This is despite two negative studies showing that this medication does not work any better than placebo. Other studies involving scuba divers and airplane travelers showed that oral pseudoephedrine is effective in decreasing MEB. However, the use of pseudoephedrine for patients undergoing HBOT has not been studied. The investigators plan to perform a randomized double blind placebo control trial to determine if pseudoephedrine is effective in decreasing the rate of MEB during HBOT.

Detailed description:
Aim 1: To investigate the efficacy of pre-treatment with oral pseudoephedrine 60mg for decreasing MEB during HBOT.

Hypothesis: Patients randomized to pseudoephedrine will have a lesser need for oxymetazoline rescue therapy while being compressed. They will also report less ear pain once at pressure compared to patients receiving placebo.

Aim 2: To measure the incidence of MEB during HBOT. The investigators will also identify factors (age, gender, medical history) that could predispose an individual to developing MEB during HBOT.

Hypothesis: The incidence of MEB defined as requiring stopping compression of the chamber and oxymetazoline rescue will be greater than 30%. Female sex, age above 60, and prior history of ear conditions will be associated with development of MEB.

Arms: arm 1: Patients randomized to pseudoephedrine prior to hyperbaric therapy arm 2: Patients randomized to placebo prior to hyperbaric therapy
Interventions: intervention 1: Hyperbaric Oxygen Therapy intervention 2: Pseudoephedrine 60 MG intervention 3: Placebo oral tablet
Intervention descriptions: intervention 1: Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atmosphere for the treatment of various emergent medical conditions. intervention 2: administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy intervention 3: administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy

Protocol documents:
Prot_SAP_002.pdf: 
Title page 
 
Protocol Title: Pseudoephedrine Prophylaxis for Prevention of Middle Ear 
Barotrauma in Hyperbaric Oxygen Therapy 
NCT Study No.: NCT04332211 
 
Principal Investigator: Siamak Moayedi, MD 
Revised Sudafed Study Protocol Date: 1/17/22 
 
 
 


Protocol 
The initial study design employed a 1:1 pseudoephedrine to placebo ratio.  At exactly half 
enrollment (42 out of 84) the research team recognized that the capsule prepared requires 15 
minutes to be dissolved, in addition to the 20-30 minutes it takes for the pseudoephedrine tablet 
to be absorbed and take effect.  Therefore, the following two changes have been applied to the 
protocol:  1. The study capsule will be administered 45 minutes prior to initiation of hyperbaric 
oxygen therapy; 2. The ratio of pseudoephedrine to placebo will be changed to 2:1 starting with 
enrollment #43; The total number of enrollments will be increased from 84 to 105.  (Because the 
participants who received the Sudafed tablet did not have enough time for the study capsule 
and tablet to be digested and take effect we can not use their data for a reliable comparison of 
Sudafed to placebo.  To reiterate, we have enrolled 21 with placebo, and 21 with badly-timed 
Sudafed. Overall, we need 42 with placebo and 42 with well-timed Sudafed based on our power 
calculation. Thus, we need another 21 (placebo) and 42 (well-timed Sudafed). This will require us 
to enroll another 63 patients with a 2:1 ratio. Thus we will need to increase the total number of 
participants we enroll for the protocol because the initial 21 with badly-timed Sudafed can not 
be used in the direct comparison calculations. In summary, in order to increase the number of 
Sudafed enrolled patients, we plan to change the enrollment ratio starting with #43 to 2 
(Sudafed) to 1 (placebo).  To reach statistical significance, based on our power calculation, we 
will need to increase our enrollment to a total of 105 (from initial 84) with the next 63 capsules 
packaged in the 2 Sudafed to 1 placebo ratio.) 
 
Additionally, given the December 2021 RNI IRB recommendations, Dr. Moayedi (PI) will be the 
only study member who reviews and sings the eligibility criteria checklist for each enrolled 
participant (this was the case previously, but now is officially in the protocol) 
 
 
Research Design and Methods 
The study will employ a prospective randomized double-blind placebo control study design 
(enrollment ratio 1:1 – this ratio is changed to 2 Sudafed to 1 placebo starting enrollment #43 
given the explanation above) to compare whether pseudoephedrine is more effective than 
placebo in preventing barotrauma during HBOT.   
 
Setting: The study will take place in the UMMC Center for Hyperbaric and Dive Medicine. 
  
Subjects: Convenience sample of patients undergoing their first HBOT. 
  
Inclusion criteria: 
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 
  
Exclusion criteria: 


Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent 
indications (example: CRAO, CO, AGE) 
Contraindication to pseudoephedrine (MAOI use, pregnancy, glaucoma, heart disease, allergy to 
drug class) 
SBP >160 
DBP > 90 
HR >100 
Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours. 
Prisoner 
Intubated 
Unable take PO meds 
  
Enrollment:  
Trained research assistants will approach patients scheduled for their initial HBOT. If the patient 
is interested in participation, informed consent will be obtained. A copy of the informed consent 
will be given to the patient, and the signature page will be collected and kept in a secure 
location. Enrolled patients will be de-identified and assigned a consecutive study number starting 
with the number one. A record on the total number of potential eligible participants approached 
will also be kept.  In order to confirm decision making capacity, the patient will be asked the 
following three questions prior to signing the consent form: 1. Why are we doing this study?; 2. 
What medication are we testing in this study?; 3. Who can you contact if you have further 
questions about the study?  If the patients are able to answer these questions and the attending 
hyperbaric physician has them sign an informed consent form for the scheduled hyperbaric 
therapy, then they are deemed competent to be enrolled in the study. In order to prevent 
enrolling pregnant patients, the attending hyperbaric physician will be asked to check the result 
of the pregnancy test.  If positive, or not available in a female patient of child bearing age, the 
patient will be excluded from the study.  The PI will be the only study member who will review 
and sign the eligibility criteria for each enrolled participant. 
 
Protocol: 
Consenting patients enrolled in the study will receive the de-identified intervention medication 
at least 45 minutes and within 120 minutes of the HBOT.  The medication will be either a 60mg 
pseudoephedrine tablet or a placebo prepared and de-identified by the UMMC Investigational 
drug pharmacy.  Both patient and all investigators and hyperbaric department staff will be 
blinded to the de-identified intervention medication.  Prior to HBOT, patients will be asked 
questions from the data collection form (see appendix A).  Study subjects will have vital signs 
checked prior to enrollment.  Otoscopy and grading of their tympanic membrane evaluation will 
be performed by the hyperbaric physician on duty prior to HBOT.  During compression phase of 
HBOT, research assistants situated outside the chamber will document the need to stop 
compression for study patients and use of rescue oxymetazoline spray.  If the study subject is 
unable to achieve compression to therapy depth, they will document the reason.  Once 
pressurization has been achieved, the depth of the therapy will be documented.  The inside 
tender will ask if the patient has any ear pain and rate is from 0-10.  This information will be 
communicated via the intercom system to the research assistant.  Once HBOT is complete, the 


hyperbaric physician will perform another otoscopic evaluation and provide a second Teed 
score.  At the conclusion of the study UMMC Investigational drug pharmacy will supply the key to 
identify the placebo versus medication.   
 
Data Collection (see appendix A): 
• 
Intervention medication ID 
• 
HBOT depth 
• 
Age 
• 
Sex (M/F/Other) 
• 
Pregnancy test result (+/ - / na) 
• 
Heart rate (beats/min) 
• 
Blood pressure 
• 
Previous trouble clearing ears on airplane (Y/N not applicable) 
• 
Active smoker – smoked cigarette w/in 24 hours (Y/N) 
• 
History of sinus disease (Y/N) 
• 
Current nasal/sinus congestion 
• 
Visual inspection of tympanic membrane prior to HBOT (Teed score) 
• 
Ear pain score prior to treatment  
Outcome Variables:   
• 
Use of rescue pseudoephedrine during compression (Y/N) 
• 
Complaint of ear pain at pressure (0-10)- categorized into severe (greater than 7/10) or 
not severe (less than 7/10) on the standard pain scale.  
• 
Completion of compression (Y/N if no, reason: ear pain, anxiety, other) 
• 
Visual inspection of tympanic membrane immediately after HBOT (Teed score) 
 
 
Statistical analysis: 
 
The sample size of 42 was calculated for enrollment into each group (use of pseudoephedrine, 
no use of rescue pseudoephedrine) to detect a significant difference in pain score between the 
treated and untreated groups. We use the standard Alpha=0.05, and power of 80%. 
This calculation was based on the incidence of barotrauma in placebo groups based on prior 
publications in scuba divers (32%). The incidence in pseudoephedrine treated group was 8%. 
 
Sample Size 
Group 1 
42 
Group 2 
42 
Total 
84 
Study Parameters 
Incidence, group 1 
32% 


Incidence, group 2 
8% 
Alpha 
0.05 
Beta 
0.2 
Power 
0.8 
 
We will screen 90 patients (5% oversample) to obtain the required subjects in each group. 
 
The primary outcome variable will be the frequency of severe pain and need for oxymetazoline 
rescue therapy, between the two groups. These frequencies will be compared using chi-square 
or Fisher’s exact test, as appropriate. We will calculate 95% confidence intervals for the 
difference in frequencies between groups using normal binomial approximation. 
 
Model building will be based on the results of the univariate analysis of independent and 
outcome variables. During model building, we will also test variables in a stepwise fashion into 
the model to identify confounders and effect modifiers.  We will then use logistic regression 
analysis to build the final model between our independent variables to our dependent or 
outcomes variable. 
Timeline:  
IRB application will be completed by mid-April 2020. 
Medical student and RN research assistant will complete CITI training and be added to the IRB 
protocol by May 2020 
UMMC Investigational drug pharmacy will be notified about the need for manufacturing and de-
identification of placebo and pseudoephedrine by mid-April 2020. 
Study will be registered with ClinicalTrials.gov by May 2020. 
Patient enrollment will begin by mid May 2020 (end of first year of medical school) 
We anticipate reaching goal of 84 enrolled patients prior to November 2020. 
Data analysis and abstract will be complete by February 2021. 
Manuscript will be submitted to Undersea and Hyperbaric Medicine Journal by March 2021.  
  
Limitations: 
Given the small sample size, it is possible that some factors, measured or unmeasured, that may 
affect ear pain or request for rescue therapy will randomly differ between pseudoephedrine and 
placebo groups.  Such factors may bias the study.   
There is inherent bias in the pain scale.  This is addressed by also examining the patient’s 
tympanic membrane and asking pain score before the patient’s treatment starts. Finally our 
results may not be generalizable given the small sample size and single center patient cohort. 
 
Human Subjects 
New patients requiring HBOT who will be approached about enrollment based on 
inclusion/exclusion criteria.  We are avoiding vulnerable study populations such as children and 
prisoners.  Informed consent will be obtained by trained study team members. 


 
We will de-identify the enrolled subjects.  We are only asking information about age, sex, 
smoking history, sinus disease, airplane flight history and current nasal congestion.  We will also 
document limited physical exams findings including heart rate, blood pressure and tympanic 
membrane evaluation.  None of these data points will provide any identifiers. 
 
With respect to the intervention, pseudoephedrine is an over the counter widely used 
medication.  We have ensured that through our exclusion criteria, we will not any significant 
cardiovascular risk to our enrolled patients. 
 
 
MATERIALS AND METHODS (from accepted manuscript for Journal of Undersea and Hyperbaric 
Medicine) 
Study design 
This was a prospective randomized, double-blind, placebo-controlled trial of pseudoephedrine 
prophylaxis in patients undergoing their first treatment of HBO2 treatment. The study was 
conducted between May 2021 and July 2023 in the multiplace HBO2 facility at the University of 
Maryland Medical Center. The study was approved by our institutional research board and 
registered with ClinicalTrials.gov (NCT04332211). 
Enrollment 
A convenience sample of new patients requiring HBO2 treatment (inpatient and outpatient) 
were approached about enrollment at the time of initial consultation. We included English-
speaking patients between the ages of 18 and 80 years. We excluded patients with 
contraindications to pseudoephedrine (monoamine oxidase inhibitor use, pregnancy, glaucoma, 
heart disease, allergy), hypertension (systolic blood pressure >160mmHg, diastolic blood 
pressure >90mmHg), tachycardia (pulse >100/minute), decongestant/antihistamine/nasal 
steroid use within 12 hours, prisoners, intubated patients, those unable to swallow a pill, history 
of hyperbaric treatment, SCUBA divers, those with pressure-equalizing tubes, and patients 
requiring emergent treatment. 
Protocol 
Consenting patients enrolled in the study ingested a study pill at least 45 minutes, and no longer 
than 120 minutes, before starting their first multiplace treatment. The pill contained either 60 
mg of pseudoephedrine or a placebo, prepared and de-identified by the hospital investigational 
drug pharmacy.  Patients, investigators, and hyperbaric department staff were blinded to the 
intervention medication. Before treatment, patients self-reported age, sex, whether they 
smoked tobacco within 24 hours, whether they had acute sinus congestion and any history of 
chronic sinus disease. We also measured their heart rate and blood pressure. Pre-treatment ear 
pain ratings were collected using a verbal numerical scale (0=no pain, 10=worst pain imaginable), 
and Teed scores (0 = normal; 1 = erythema of TM; 2 = erythema and slight hemorrhage within 


TM; 3 = gross hemorrhage within TM; 4 = hemotympanum; 5 = perforation of TM) were 
documented on every patient. The rate of compression change was constant for all participants 
(0.15 atmospheres absolute per minute). Patient education about methods to equalize ear 
pressure and not succumbing to “peer pressure” (and thus not declaring inability to equalize) 
when other patients were in the multiplace hyperbaric chamber was standardized for every 
enrollment. Patients unable to equalize ear pressure during compression were given 
oxymetazoline nasal spray as rescue therapy. The need to pause compression for the use of 
oxymetazoline was documented. We documented the reason why the study participant could 
not achieve compression. Pain ratings at target or maximum pressure tolerated were collected. 
Teed scores were documented on every patient after treatment upon exiting the chamber (by 
the same physician that performed the pre-treatment Teed evaluation). We considered severe 
pain as >7/10 or requiring abortion of HBO2 treatment. 
Statistical analysis 
Our comparisons were based on our primary outcome measures (pain ratings, Teed scores, and 
oxymetazoline rescue therapy) between placebo and pseudoephedrine. Our sample size, based 
on power 0.8, significance 0.05, and effect size 8% versus 32%, was 42 patients in each group. 
The effect size was based on barotrauma measured in SCUBA divers [10]. Initial allocation was 
1:1, but by the 42nd enrollment, we learned that the capsules prepared by the investigational 
drug pharmacy required additional dissolution time, necessitating a 45-minute wait rather than 
the original 30-minute protocol. Because of inadequate time for drug effect, patients assigned 
pseudoephedrine up to that point were not considered for the primary outcome comparison. 
Thus, we subsequently changed our allocation to 2:1 to increase the number receiving 
pseudoephedrine, starting with subject #43. This increased our total enrollment from 84 to 105.  
For comparisons of placebo versus pseudoephedrine, we used only subjects with 
pseudoephedrine ingested at least 45 minutes before HBO2 treatment. We used data from 
subjects provided pseudoephedrine less than 45 minutes before treatment only for estimates of 
the incidence of complications of HBO2 treatment. 
We compared frequencies of primary outcome measures using chi-square or Fisher’s 
exact test, as appropriate. We calculated 95% confidence intervals for the difference in 
frequencies between categories using normal binomial approximation. We compared ordinal 
variables using the Wilcoxon rank sum test.  
We used logistic regression to adjust for potential confounding by baseline variables (age, 
sex, HBO2 pressure, history of obstruction, sinus disease, smoking, and inpatient status). We 
used backward selection, aiming for a precise and unbiased estimate of the pseudoephedrine 
effect. We removed only variables whose removal would not change this estimate by >10% or 
increase the standard error by >20%.  
 

ICF_003.pdf: 
Page 1 of 7
RESEARCH CONSENT FORM
Protocol Title: Pseudoephedrine Prophylaxis for Prevention of Middle Ear 
Barotrauma in Hyperbaric Oxygen Therapy
Study No.: HP-00090947
Principal Investigator: Siamak Moayedi, MD. Telephone: (410) 328-6152
Sponsor: University of Maryland Department of Emergency Medicine
CONCISE SUMMARY:
This is a voluntary research study evaluating whether pseudoephedrine (Sudafed) will help 
prevent ear pain during hyperbaric therapy.  Because you are a patient scheduled to receive 
hyperbaric oxygen therapy (HBOT), we would like your consent to help with this study.  
Prior to your HBOT session, we will give you an unlabeled pill to take. This will be either a 
placebo (fake) pill or a pseudoephedrine pill in order to compare effects on preventing ear pain.
The risks of the study include middle ear pain from the hyperbaric oxygen therapy, as well as 
potential side effects of pseudoephedrine such as headache, restlessness or irregular heartbeats. 
However, pseudoephedrine is a commonly used over-the-counter medication, and we will have 
screened you for any significant heart-related risk prior to this study.
If you are interested in learning more about this study, please continue to read below.  
Additionally the study is registered with clinicaltrial.gov and you can find more information by 
looking up title of the study.
PURPOSE OF STUDY
We are comparing the use of pseudoephedrine to placebo in preventing middle ear trauma during 
hyperbaric oxygen therapy. You will be one of up to 105 participants who will be enrolled in this 
study.
PROCEDURES
We will check your blood pressure and heart rate prior to enrollment of the study. Before you 
begin your hyperbaric oxygen therapy, we will give you an unlabeled pill sometime between the 
time period of 45 minutes before your session and within 120 minutes of the session beginning. 
Neither you nor the researchers will be aware of which pill you are given. 
The hyperbaric physician on duty will examine your ears prior to the therapy session to look for 
any pre-existing ear trauma. 
During the therapy, a nurse inside the chamber will ask you if you have any ear pain on the scale 
of 1 to 10, 10 being the most severe pain. This information will be shared with the researchers 
HP-00090947 UM IRB Approval Date 3/30/2023
Do Not Sign this Form after this Date 3/29/2024
NCT04332211


Page 2 of 7                                              Pseudoephedrine Prophylaxis for the Prevention of Middle Ear Barotrauma 
in Hyperbaric Oxygen Therapy (HP-00090947)
outside the chamber for them to document. The researchers will be outside the chamber to record 
the need to stop the therapy due to any ear pain and provide a rescue medication for pain relief if 
needed. 
Once the therapy is completed, the hyperbaric physician will again examine your ears for follow-
up. There are no additional tests required for this study after completion of your therapy session 
and ear examination. The duration of your involvement will be dependent on the length of your 
HBOT session. If you are unable to complete your therapy session, we will document the reason 
and end your participation in the study. 
WHAT ARE MY RESPONSIBILITIES IF I TAKE PART IN THIS RESEARCH?
If you take part in this research, you will be responsible for taking the provided unlabeled pill, 
informing us of any ear pain during your HBOT session, and allowing us to examine your ears 
before and after the therapy. 
POTENTIAL RISKS/DISCOMFORTS:
You may experience ear pain during HBOT. The nurse inside the chamber will be monitoring 
you during the session, and the research assistants will be outside the chamber to stop the therapy 
and provide rescue medication for any ear pain. If you experience any other reason for stopping 
your HBOT, we will end the study session. 
Pseudoephedrine is a common over-the-counter medication used for decongestion but may be 
associated with side effects including restlessness, nausea, vomiting, headache, dizziness, 
stomach pain, difficulty breathing and irregular heartbeats. The attending nurse and hyperbaric 
physician, as well as the research assistants, will be monitoring you for any discomforts. 
POTENTIAL BENEFITS
By helping with this research, you may experience reduced ear pain and trauma from taking 
pseudoephedrine. Ultimately, your participation will help future HBOT patients by helping to 
prevent ear pain/trauma. 
PAYMENT PARTICIPANTS
There is no payment for participation.
ALTERNATIVES TO PARTICIPATION
Participation is completely voluntary.  You may choose not to participate and even change your 
mind at any point even after signing this consent form.
COSTS TO PARTICIPANTS
It will not cost you anything to take part in this study.
CONFIDENTIALITY AND ACCESS TO RECORDS
We will not collect your name or medical record number.  Efforts will be made to limit your 
personal information, including your age, gender, smoking history, sinus disease, airplane flight 
HP-00090947 UM IRB Approval Date 3/30/2023
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Page 3 of 7                                              Pseudoephedrine Prophylaxis for the Prevention of Middle Ear Barotrauma 
in Hyperbaric Oxygen Therapy (HP-00090947)
history and current nasal congestion, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information 
include the IRB and other representatives of this organization. The data from the study may be 
published. However, you will not be identified by name. People designated from the institutions 
where the study is being conducted and people from the sponsor will be allowed to inspect 
sections of your medical and research records related to the study. Everyone using study 
information will work to keep your personal information confidential. Your personal information 
will not be given out unless required by law.
RIGHT TO WITHDRAW
Your participation in this study is voluntary. You do not have to take part in this research. You 
are free to withdraw your consent at any time. Refusal to take part or to stop taking part in the 
study will involve no penalty or loss of benefits to which you are otherwise entitled. If you 
decide to stop taking part, or if you have questions, concerns, or complaints, or if you need to 
report a medical injury related to the research, please contact the study team member who is with 
you in the electrophysiology lab. If you withdraw from this study, already collected data may not 
be removed from the study database.  If you have questions, concerns, or complaints, please 
contact the investigator Dr. Moayedi at (410) 328-6152.
CAN I BE REMOVED FROM THE RESEARCH?
The person in charge of the research study or the sponsor can remove you from the research 
study without your approval.
UNIVERSITY STATEMENT CONCERNING RESEARCH RISKS
The University of Maryland, Baltimore (UMB) is committed to providing participants in its research the 
rights due them under State and federal law. You give up none of your legal rights by signing this consent 
form or by participating in the research project. This research has been reviewed and approved by the 
Institutional Review Board (IRB). Please call the Institutional Review Board (IRB) if you have questions 
about your rights as a research subject.
Participating in research may result in an injury, as explained above. If you suffer an injury directly 
related to your participation in this project, UMB and/or one of its affiliated institutions or health care 
groups will help you obtain medical treatment for the specific injury and provide referrals to other health 
care facilities, as appropriate. UMB and/or its affiliated institutions or health care groups will not provide 
you with financial compensation or reimbursement for the cost of care provided to treat a research-related 
injury or for other expenses arising from a research-related injury. The institution or group providing 
medical treatment will charge your insurance carrier, you, or any other party responsible for your 
treatment costs. If you incur uninsured medical costs, they are your responsibility. The study staff can 
give you more information about this if you have a study injury.
By signing this Consent Form, you are not giving up any legal rights. If this research project is conducted 
in a negligent manner and you are injured as a direct result, you may be able to recover the costs of care 
and other damages from the individuals or organizations responsible for your injury.
HP-00090947 UM IRB Approval Date 3/30/2023
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Page 4 of 7                                              Pseudoephedrine Prophylaxis for the Prevention of Middle Ear Barotrauma 
in Hyperbaric Oxygen Therapy (HP-00090947)
If you have questions, concerns, complaints, or believe you have been harmed through participation in 
this research study as a result of researcher negligence, you can contact members of the IRB or the 
Human Research Protections Office (HRPO) to ask questions, discuss problems or concerns, obtain 
information, or offer input about your rights as a research participant. The contact information for the IRB 
and the HRPO is:
University of Maryland Baltimore
Human Research Protections Office 
620 W. Lexington Street, Second Floor
Baltimore, MD 21201
410-706-5037
HP-00090947 UM IRB Approval Date 3/30/2023
Do Not Sign this Form after this Date 3/29/2024


Page 5 of 7                                              Pseudoephedrine Prophylaxis for the Prevention of Middle Ear Barotrauma 
in Hyperbaric Oxygen Therapy (HP-00090947)
Signing this consent form indicates that you have read this consent form (or have had it read to you), that 
your questions have been answered to your satisfaction, and that you voluntarily agree to participate in this 
research study. You will receive a copy of this signed consent form.
If you agree to participate in this study, please sign your name below.
___________________________________
Participant’s Signature
Date:______________________________
___________________________________
Investigator or Designee Obtaining Consent 
Signature
Date:______________________________
HP-00090947 UM IRB Approval Date 3/30/2023
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Page 6 of 7                                              Pseudoephedrine Prophylaxis for the Prevention of Middle Ear Barotrauma 
in Hyperbaric Oxygen Therapy (HP-00090947)
Health Insurance Portability and Accountability Act (HIPAA)
AUTHORIZATION TO OBTAIN, USE AND DISCLOSE
PROTECTED HEALTH INFORMATION FOR RESEARCH
Name of Study Participant:______________________________________________ 
Date of Birth:  ________________                   Medical Record Number: ____________    
NAME OF THIS RESEARCH STUDY:  
Pseudoephedrine Prophylaxis for Prevention of Middle 
Ear Barotrauma in Hyperbaric Oxygen Therapy
UMB IRB APPROVAL NUMBER: 
HP- 00090947
RESEARCHER’S NAME: 
SIAMAK MOAYEDI, MD
RESEARCHER’S CONTACT INFORMATION: 
UMMC Center for Hyperbaric and Dive Medicine
22 S. Greene St. Ground Floor, West Elevator
Baltimore, MD 21201
(410) 328-6152
This research study will use health information that identifies you. If you agree to participate, 
this researcher will use just the health information listed below.
THE SPECIFIC HEALTH INFORMATION TO BE USED OR SHARED:

Age

Sinus disease past medical history

Smoking history

Any current nasal congestion
Federal laws require this researcher to protect the privacy of this health information. He/she will share it 
only with the people and groups described here.
PEOPLE AND ORGANIZATIONS WHO WILL USE OR SHARE THIS INFORMATION:

Dr. Siamak Moayedi and his research team.

The sponsor of the study, or its agents, such as data repositories or contract research organizations
THIS AUTHORIZATION WILL NOT EXPIRE.  BUT YOU CAN REVOKE IT AT ANY TIME.
To revoke this Authorization, send a letter to this researcher stating your decision. He/she will stop 
collecting health information about you. This researcher might not allow you to continue in this study. 
He/she can use or share health information already gathered. 
HP-00090947 UM IRB Approval Date 3/30/2023
Do Not Sign this Form after this Date 3/29/2024


Page 7 of 7                                              Pseudoephedrine Prophylaxis for the Prevention of Middle Ear Barotrauma 
in Hyperbaric Oxygen Therapy (HP-00090947)
ADDITIONAL INFORMATION:

You can refuse to sign this form. If you do not sign it, you cannot participate in this study. This 
will not affect the care you receive at:
o
University Physicians, Inc. (UPI)
o
University of Maryland Medical System (UMMS)
It will not cause any loss of benefits to which you are otherwise entitled.

Sometimes, government agencies such as the Food and Drug Administration or the Department of 
Social Services request copies of health information. The law may require this researcher, the 
UMSOM, UPI, UMMS to give it to them.

This researcher will take reasonable steps to protect your health information. However, federal 
protection laws may not apply to people or groups outside the UMSOM, UMB, UPI, UMMS.   

Except for certain special cases, you have the right to a copy of your health information created 
during this research study. You may have to wait until the study ends. Ask this research how to 
get a copy of this information from him/her.
My signature indicates that I authorize the use and sharing of my protected health information for the 
purposes described above. I also permit my doctors and other health care providers to share my 
protected health information with this researcher for the purposes described above. 
Signature:  ____________________________________Date: _______________________
Name (printed) ______________________________________
Privacy Questions? Call the UMSOM Privacy Official (410-706-0337) with questions about your/your child’s rights 
and protections under privacy rules.
Other Questions? Call the researcher named on this form with any other questions.
HP-00090947 UM IRB Approval Date 3/30/2023
Do Not Sign this Form after this Date 3/29/2024