Air Bone GapNCT02493686
Age Dependence of Audiometric Bone Conduction Threshold in Normal Hearing Subjects
An observational study of Air Bone Gap, run by University of Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Air Bone Gap
- What is being tested?
- audiogram
- How many people
- 1,093 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Persons which have a normal hearing threshold level in the airconduction.
Who may be able to join
- 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
Who cannot join
- age younger than 20 years
- if inclusion criteria not given
About this study
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.
- Conditions
- Air Bone Gap
- Being tested
- audiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
audiogramDiagnostic test
hearing test
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1960 - 2014 (54 years)
Secondary outcomes (1)
Air bone gap changes in individuals who have received more than one Audiogram
Measured: 1960 - 2014 (54 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air Bone GapStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudolf Probst, Prof., Study director, University Hospital Zurich, clinic othorhinolaryngology, 8091 Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493686
- Sponsor's protocol ID
- PR_16_09_2014
- Status last verified
- Nov 2015
- First submitted
- 2 Jun 2015
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age Dependence of Audiometric Bone Conduction Threshold in Normal Hearing Subjects
- ClinicalTrials.gov ID
- NCT02493686
- Acronym / sponsor ID
- PR_16_09_2014
- Conditions
- Air Bone Gap
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,093 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Persons which have a normal hearing threshold level in the airconduction.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- age younger than 20 years
- if inclusion criteria not given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| audiogramhearing test | Diagnostic test | – |
Primary outcome
Bone conduction Threshold/ Air bone gap in normal hearing subject in relation to age
Time frame: 1960 - 2014 (54 years)
from the initial establishment of the database until collection of the data
1 secondary outcome
Air bone gap changes in individuals who have received more than one Audiogram
Time frame: 1960 - 2014 (54 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudolf Probst, Prof. study director
University Hospital Zurich, clinic othorhinolaryngology, 8091 Zurich
Questions about this trial
What is this clinical trial studying?
An observational study of Air Bone Gap, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone conduction Threshold/ Air bone gap in normal hearing subject in relation to age (time frame: 1960 - 2014 (54 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.