Body Mass Index and Audiology Function
Effect of Increased Body Mass Index on Auditory Function
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Obesity may directly or indirectly lead to hearing loss
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2017
CompletedFirst Posted
Study publicly available on registry
June 1, 2017
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedJune 6, 2017
May 1, 2017
1 year
May 26, 2017
June 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
body mass index
if increased body mass index affect auditory function assessed by pure tone audiomertry
20 minutes
Study Arms (2)
group 1
EXPERIMENTALgroup 2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 22253364BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
May 26, 2017
First Posted
June 1, 2017
Study Start
May 1, 2018
Primary Completion
May 1, 2019
Study Completion
November 1, 2019
Last Updated
June 6, 2017
Record last verified: 2017-05