Body Mass Index and Audiology Function

June 4, 2017 updated by: NElshreef, Assiut University

Effect of Increased Body Mass Index on Auditory Function

Obesity may directly or indirectly lead to hearing loss

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
Device: pure tone audiometry
for estimate the type and degree of hearing loss
Active Comparator: group 2
Device: pure tone audiometry
for estimate the type and degree of hearing loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body mass index
Time Frame: 20 minutes
if increased body mass index affect auditory function assessed by pure tone audiomertry
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

May 26, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUDIO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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