Back to resultsBody Mass Index and Audiology Function
Primary Purpose
Hearing Loss
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pure tone audiometry
Sponsored by
About this trial
This is an interventional prevention trial for Hearing Loss focused on measuring obesity
Eligibility Criteria
Inclusion Criteria:
It will include 50 subjects whose:
- Age ranges from 10 to 40 years old.
- Body Mass Index more than the 85th percentile.
- male and female will be included
Exclusion Criteria:
- External or middle ear disease that causes conductive hearing loss such as otitis media, otomycosis, perforated drum, tumors, dislocation of the ossicles.
- High environmental noise exposure which causes acoustic trauma such as exploration, fire shots and noise in industries.
- ototoxic drug intake such as Aspirin, Aminoglycosides, Erythromycin, Vancomycin Streptomycin, Kanamycin, Neomycin, Gentamycin, Tobramycin, Lasix, Cisplatin, Nitrogen Mustard, and Vincristine, and Quinine.
- Major neurological or psychiatric diseases brain tumor, vestibular Schwannoma, stroke, acoustic neuroma, encephalitis, meningitis, and depression.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group 1
group 2
Arm Description
Outcomes
Primary Outcome Measures
body mass index
if increased body mass index affect auditory function assessed by pure tone audiomertry
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03172663
Brief Title
Body Mass Index and Audiology Function
Official Title
Effect of Increased Body Mass Index on Auditory Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
November 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Obesity may directly or indirectly lead to hearing loss
Detailed Description
Obesity is measured by Body Mass Index.it is calculated by dividing a person's weight in kilograms by the square of height in meters. For children and adolescent. Overweight is defined as Body Mass Index is <85th percentile <95th percentile but obesity is defined as body mass index at or above the 95th percentile for children and teens of the same age and sex the increasing in body mass index mass may affect auditory function Directly as adipose tissue secretes hormones and cytokines, proinflammatory cytokines lead to release of obesity-induced inflammation which may directly contribute to end-organ damage Also, Adiponectin, which is thought to have anti-inflammatory and antiatherogenic effects, and associated with favorable lipoprotein profile, independent of BMI and insulin resistance, low plasma concentrations of adiponectin have been associated with obesity in children. In adults, low level of adiponectin has been associated with elevated high-frequency thresholds.
Indirectly, by obesity comorbidities including Hypertension, Type 2 diabetes mellitus, Dyslipidemia , Metabolic Syndrome and Cardiovascular Diseases
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Title
group 2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
pure tone audiometry
Intervention Description
for estimate the type and degree of hearing loss
Primary Outcome Measure Information:
Title
body mass index
Description
if increased body mass index affect auditory function assessed by pure tone audiomertry
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
It will include 50 subjects whose:
Age ranges from 10 to 40 years old.
Body Mass Index more than the 85th percentile.
male and female will be included
Exclusion Criteria:
External or middle ear disease that causes conductive hearing loss such as otitis media, otomycosis, perforated drum, tumors, dislocation of the ossicles.
High environmental noise exposure which causes acoustic trauma such as exploration, fire shots and noise in industries.
ototoxic drug intake such as Aspirin, Aminoglycosides, Erythromycin, Vancomycin Streptomycin, Kanamycin, Neomycin, Gentamycin, Tobramycin, Lasix, Cisplatin, Nitrogen Mustard, and Vincristine, and Quinine.
Major neurological or psychiatric diseases brain tumor, vestibular Schwannoma, stroke, acoustic neuroma, encephalitis, meningitis, and depression.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed salama bakr, Professor
Phone
1006550289
Ext
+20
Email
mohamedsalamabakr@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
amira Mohammad Abdel Moneim, Lecturer
Phone
1095495110
Ext
+20
Email
Amira_oseily@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
22253364
Citation
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA. 2012 Feb 1;307(5):483-90. doi: 10.1001/jama.2012.40. Epub 2012 Jan 17.
Results Reference
background
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Body Mass Index and Audiology Function
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