Inner and Middle Ear Effects of Hyperbaric Oxygen Thrapy

NCT ID: NCT04186741

Last Updated: 2020-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-30

Study Completion Date

2022-06-30

Brief Summary

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Audiological evaluation performed to patients on hyperbaric oxygen therapy to see its effects on middle ear pressure

Detailed Description

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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

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Otitic Barotrauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HBO Group

Patients already recieving hyperbaric oxygen therapy for treatment of other medical conditions requiring it as in diabetic foot , cerebral infarctions

Hyperbaric oxygen

Intervention Type DRUG

Patients already on treatment by hyperbaric oxygen therapy for medical conditions requiring treatment by it

Interventions

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Hyperbaric oxygen

Patients already on treatment by hyperbaric oxygen therapy for medical conditions requiring treatment by it

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients above 18 years old already recieving hyperbaric oxygen therapy for treatment of other medical conditions required treatment by it as in diabetic foot

Exclusion Criteria

* patients who already had tympanostomy tubes
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Nahla Ahmed Abd elhafez Mousa

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enas S Mohamed, Professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Nahla A Mousa

Role: CONTACT

01142338708

Eman A Elgendy, Professor

Role: CONTACT

Facility Contacts

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Nahla A Mousa

Role: primary

References

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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.

Reference Type RESULT
PMID: 26650550 (View on PubMed)

Other Identifiers

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IMO

Identifier Type: -

Identifier Source: org_study_id

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