Otitic BarotraumaNCT04186741
Inner and Middle Ear Effects of Hyperbaric Oxygen Thrapy
An observational study of Otitic Barotrauma, run by Assiut University at 1 site in Egypt.
Trial summary
Audiological evaluation performed to patients on hyperbaric oxygen therapy to see its effects on middle ear pressure Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Otitic Barotrauma
- What is being tested?
- Hyperbaric oxygen
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2021to Jun 2022
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Measument of middle ear pressure after exposure to hyper baric oxygen therapy
Who may be able to join
- patients above 18 years old already recieving hyperbaric oxygen therapy for treatment of other medical conditions required treatment by it as in diabetic foot
Who cannot join
- patients who already had tympanostomy tubes
Trial locations and contacts
1 site in 1 country.
Eman A Elgendy, Professor contact
About this study
Official title: Inner and Middle Ear Effects of Hyperbaric Oxygen Therapy
Audiological evaluation performed to patients on hyperbaric oxygen therapy to see its effects on middle ear pressure
Read the detailed description
Thirty patients will be recruited from center pf hyperbaric oxygen therapy Every patient who received HBOT was submitted for Demographic data:age,gender,condition raquiring HBOT,use of analgesics,history of diabets ,cardiovascular or respiratory disease ,psychatric illness,smoking history facial/ENT problems and previous HBOT problems then tympanometry and basic pure tone audiometry including air and bone conduction is done following each of the first five treatment
- Conditions
- Otitic Barotrauma
- Being tested
- Hyperbaric oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenDrug
Patients already on treatment by hyperbaric oxygen therapy for medical conditions requiring treatment by it
| Study group | Role | What they receive |
|---|---|---|
| HBO Group | Patients already recieving hyperbaric oxygen therapy for treatment of other medical conditions requiring it as in diabetic foot , cerebral infarctions Receives: Drug: Hyperbaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing in middle ear pressure
Measuring middle ear pressure before exposure ro hyperbaric oxygen and following each of the first five treatments
Measured: Through completion of study after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study startApr 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 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
- Investigators
- Enas S Mohamed, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186741
- Sponsor's protocol ID
- IMO
- Status last verified
- Dec 2019
- First submitted
- 15 Nov 2019
- Last updated
- 9 Jul 2020
- Results posted
- No
Publications
Yamamoto Y, Noguchi Y, Enomoto M, Yagishita K, Kitamura K. Otological complications associated with hyperbaric oxygen therapy. Eur Arch Otorhinolaryngol. 2016 Sep;273(9):2487-93. doi: 10.1007/s00405-015-3845-9. Epub 2015 Dec 9.
PubMed 26650550
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inner and Middle Ear Effects of Hyperbaric Oxygen Therapy
- ClinicalTrials.gov ID
- NCT04186741
- Acronym / sponsor ID
- IMO
- Conditions
- Otitic Barotrauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 5 Dec 2019 (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.
Audiological evaluation performed to patients on hyperbaric oxygen therapy to see its effects on middle ear pressure
Detailed description
Thirty patients will be recruited from center pf hyperbaric oxygen therapy Every patient who received HBOT was submitted for Demographic data:age,gender,condition raquiring HBOT,use of analgesics,history of diabets ,cardiovascular or respiratory disease ,psychatric illness,smoking history facial/ENT problems and previous HBOT problems then tympanometry and basic pure tone audiometry including air and bone conduction is done following each of the first five treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBO Group | – | Drug: Hyperbaric oxygenPatients already recieving hyperbaric oxygen therapy for treatment of other medical conditions requiring it as in diabetic foot , cerebral infarctions |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Measument of middle ear pressure after exposure to hyper baric oxygen therapy
Key inclusion criteria (1 listed)
- patients above 18 years old already recieving hyperbaric oxygen therapy for treatment of other medical conditions required treatment by it as in diabetic foot
Key exclusion criteria (1 listed)
- patients who already had tympanostomy tubes
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 |
|---|---|---|
| Hyperbaric oxygenPatients already on treatment by hyperbaric oxygen therapy for medical conditions requiring treatment by it | Drug | HBO Group |
Primary outcome
Changing in middle ear pressure
Time frame: Through completion of study after 2 years
Measuring middle ear pressure before exposure ro hyperbaric oxygen and following each of the first five treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Results publication: PubMed 26650550Yamamoto Y, Noguchi Y, Enomoto M, Yagishita K, Kitamura K. Otological complications associated with hyperbaric oxygen therapy. Eur Arch Otorhinolaryngol. 2016 Sep;273(9):2487-93. doi: 10.1007/s00405-015-3845-9. Epub 2015 Dec 9.
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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.
Eman A Elgendy, Professor contact
Enas S Mohamed, Professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitic Barotrauma, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 9 Jul 2020. 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 Egypt. 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. 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?
Contact Nahla A Mousa (01142338708, totydodeg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing in middle ear pressure (time frame: Through completion of study after 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04186741, which also lists 1 linked publication.
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 9 Jul 2020.