NCT03172663

Brief Summary

Obesity may directly or indirectly lead to hearing loss

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Status
unknown

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

June 6, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 26, 2017

Last Update Submit

June 4, 2017

Conditions

Keywords

obesity

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

EXPERIMENTAL
Device: pure tone audiometry

group 2

ACTIVE COMPARATOR
Device: pure tone audiometry

Interventions

for estimate the type and degree of hearing loss

group 1group 2

Eligibility Criteria

Age10 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Hearing LossObesity

Interventions

Audiometry, Pure-Tone

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Intervention Hierarchy (Ancestors)

AudiometryHearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

mohammed salama bakr, Professor

CONTACT

amira Mohammad Abdel Moneim, Lecturer

CONTACT

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