Inner and Middle Ear Effects of Hyperbaric Oxygen Thrapy

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04186741

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Otitic Barotrauma	Drug: Hyperbaric oxygen

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

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Inner and Middle Ear Effects of Hyperbaric Oxygen Therapy

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
HBO Group Patients already recieving hyperbaric oxygen therapy for treatment of other medical conditions requiring it as in diabetic foot , cerebral infarctions	Drug: Hyperbaric oxygen Patients already on treatment by hyperbaric oxygen therapy for medical conditions requiring treatment by it

Arm

Intervention/Treatment

HBO Group

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

Drug: Hyperbaric oxygen

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

Outcome Measures

Primary Outcome Measures

Changing in middle ear pressure [Through completion of study after 2 years]
Measuring middle ear pressure before exposure ro hyperbaric oxygen and following each of the first five treatments

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Enas S Mohamed, Professor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nahla Ahmed Abd elhafez Mousa, Principle investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT04186741

Other Study ID Numbers:

First Posted:

Dec 5, 2019

Last Update Posted:

Jul 9, 2020

Last Verified:

Dec 1, 2019

Additional relevant MeSH terms:

Barotrauma

Study Results

No Results Posted as of Jul 9, 2020