Age Dependence of Audiometric Bone Conduction Threshold i... | NCT02493686

Studies
Age Dependence of Audiometric Bone Conduction Threshold in Normal Hearing Subjects

NCT02493686

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Nov 16, 2020Actual

Enrollment

1,093Actual

Phase

Not provided

Conditions

Air Bone Gap

Interventions

audiogram

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Aug 2015Actual

Completion Date

Nov 2020Actual

First Submitted Date

Jun 2, 2015

First Submission Date that Met QC Criteria

Jul 6, 2015

First Posted Date

Jul 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2020

Last Update Posted Date

Nov 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Examination of the bone conduction of persons which according to the pure tone audiogram have a normal age related hearing threshold in the air conduction.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,093Actual

Name	Type	Description	Arm Group Labels	Other Names
audiogram	Diagnostic Test	hearing test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone conduction Threshold/ Air bone gap in normal hearing subject in relation to age	from the initial establishment of the database until collection of the data	1960 - 2014 (54 years)

Secondary Outcomes

Measure	Description	Time Frame
Air bone gap changes in individuals who have received more than one Audiogram		1960 - 2014 (54 years)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All pure tone audiograms recorded and available in the system from the beginning of measurement as follows:
age related normal hearing threshold level with air conducted pure tone audiogram

Exclusion Criteria:

age younger than 20 years
if inclusion criteria not given

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Persons which have a normal hearing threshold level in the airconduction.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rudolf Probst, Prof.	University Hospital Zurich, clinic othorhinolaryngology, 8091 Zurich	Study Director

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001299	Audiometry

Ancestor Terms

ID	Term
D006320	Hearing Tests
D003939	Diagnostic Techniques, Otological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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Browse Branches

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