Middle Ear BarotraumaHBOTNCT06209021
Effects of Hyperbaric Oxygen Therapy on Middle and Inner Ear Functions
An observational study of Middle Ear Barotrauma, run by Assiut University.
Trial summary
The goal of this observational study is to measure the effect of hyperbaric oxygen therapy on middle ear pressure in order to predict the risk factors for middle ear barotrauma also, to assess its effects on hearing functions of the inner ear in participant population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Middle Ear Barotrauma
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of both sexes already recommended to be treated by hyperbaric oxygen therapy for various medical conditions in hyperbaric oxygen therapy center.
Who may be able to join
- Patients of at least 18 years old.
- Patients accept participation in the research.
- Patients with out history of middle ear diseases.
Who cannot join
- Patients under age of 18 years old.
- Patients have middle ear effusion.
- Patients refuse to participate in the research.
About this study
The goal of this observational study is to measure the effect of hyperbaric oxygen therapy on middle ear pressure in order to predict the risk factors for middle ear barotrauma also, to assess its effects on hearing functions of the inner ear in participant population. The main questions aim to answer are:
- Is there a change in middle ear pressure before and after exposure to hyperbaric oxygen therapy ?
- Is there a change in hearing threshold level before and after exposure to hyperbaric oxygen therapy ? The middle ear pressure, eustachian tube functions and the hearing threshold of the participants will be assessed immediately before the fist session and within one hour after the first and tenth sessions.
Read the detailed description
Fifty four patients already treated by hyperbaric oxygen therapy recruited from hyperbaric oxygen therapy center of Assiut university hospitals. Otoscopic examination for all patients must be done before and after the session , assessment of middle ear pressure and the state of the eustachian tube through doing eustachian tube function tests (Valsalva and Toynbee tests for ears with intact tympanic membrane and modified inflation - deflation tests for ears with perforated tympanic membrane) by tympanometry for all patients before and after the first session of hjyperbaric oxygen therapy and after completion of the tenth session. Assessment of the hearing threshold level of the patients immediately before the first session and after the tenth session of hyperbaric oxygen therapy through doing pure tone audiometry ( air conduction and bone conduction audiometry) and speech audiometry to assess the speech discrimination score for the patients
- Conditions
- Middle Ear Barotrauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the changes of the middle ear pressure after exposure to hyperbaric oxygen therapy
Tympanometric assessment of the middle ear pressure and eustachian tube functions
Measured: Immediately before exposure to the first session of hyperbaric oxygen therapy and within one hour after exposure to the first and tenth session of hyperbaric oxygen therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle Ear BarotraumaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Ahmed Abd elhafez Mousa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209021
- Sponsor's protocol ID
- Audiology2024
- Acronym
- HBOT
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hyperbaric Oxygen Therapy on Middle and Inner Ear Functions
- ClinicalTrials.gov ID
- NCT06209021
- Acronym / sponsor ID
- HBOT / Audiology2024
- Conditions
- Middle Ear Barotrauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 17 Jan 2024 (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 goal of this observational study is to measure the effect of hyperbaric oxygen therapy on middle ear pressure in order to predict the risk factors for middle ear barotrauma also, to assess its effects on hearing functions of the inner ear in participant population. The main questions aim to answer are:
- Is there a change in middle ear pressure before and after exposure to hyperbaric oxygen therapy ?
- Is there a change in hearing threshold level before and after exposure to hyperbaric oxygen therapy ? The middle ear pressure, eustachian tube functions and the hearing threshold of the participants will be assessed immediately before the fist session and within one hour after the first and tenth sessions.
Detailed description
Fifty four patients already treated by hyperbaric oxygen therapy recruited from hyperbaric oxygen therapy center of Assiut university hospitals. Otoscopic examination for all patients must be done before and after the session , assessment of middle ear pressure and the state of the eustachian tube through doing eustachian tube function tests (Valsalva and Toynbee tests for ears with intact tympanic membrane and modified inflation - deflation tests for ears with perforated tympanic membrane) by tympanometry for all patients before and after the first session of hjyperbaric oxygen therapy and after completion of the tenth session. Assessment of the hearing threshold level of the patients immediately before the first session and after the tenth session of hyperbaric oxygen therapy through doing pure tone audiometry ( air conduction and bone conduction audiometry) and speech audiometry to assess the speech discrimination score for the patients
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both sexes already recommended to be treated by hyperbaric oxygen therapy for various medical conditions in hyperbaric oxygen therapy center.
Key inclusion criteria (3 listed)
- Patients of at least 18 years old.
- Patients accept participation in the research.
- Patients with out history of middle ear diseases.
Key exclusion criteria (3 listed)
- Patients under age of 18 years old.
- Patients have middle ear effusion.
- Patients refuse to participate in the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measuring the changes of the middle ear pressure after exposure to hyperbaric oxygen therapy
Time frame: Immediately before exposure to the first session of hyperbaric oxygen therapy and within one hour after exposure to the first and tenth session of hyperbaric oxygen therapy.
Tympanometric assessment of the middle ear pressure and eustachian tube functions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Recruiting
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Middle Ear Barotrauma, run by Assiut University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the changes of the middle ear pressure after exposure to hyperbaric oxygen therapy (time frame: Immediately before exposure to the first session of hyperbaric oxygen therapy and within one hour after exposure to the first and tenth session of hyperbaric oxygen therapy.). 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 17 Jan 2024.