Hearing LossNCT04322747
Hearing Changes After Surgery
An observational study of Hearing Loss, run by Gateway Biotechnology, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the ear contralateral to the surgical site during skull-based surgeries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Distortion product otoacoustic emissions (DPOAE)
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 28 Feb 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants scheduled to undergo skull-based and mastoid surgery
Who may be able to join
- participants are undergoing a skull-based or mastoid surgery for treatment of an affected ear
- participants have normal or near-normal hearing thresholds in the un-operated ear
Who cannot join
- participants have hearing loss (PTA > 40 dB HL) in pure tone audiometry testing before surgery in the un-operated ear
- participants have medical conditions after the surgery which prevents having hearing tests
- participants have abnormal tympanometric results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hearing Changes After Skull Base and Mastoid Surgery
The purpose of this study is to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the ear contralateral to the surgical site during skull-based surgeries
Read the detailed description
High-speed drills that are capable of producing elevated levels are used during skull based surgeries (Hilmi et al., 2011; Yu et al., 2014). Recently, it has been shown that surgical drilling may have a temporary effect on the amplitude of the otoacoustic emissions of the ear contralateral to the surgical site (Baradaranfar et al., 2015; Shenoy et al., 2015), however the temporary effects of surgical noise or vibration on the hearing of the non-surgical related ear needs to be better quantified. This study aims to to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the non operative ear, during surgical site during skull-based or mastoid surgeries. As part of the study patient will receive Audiometry for extended high frequencies, DPOAE, ECochG before and after the procedure.
- Conditions
- Hearing Loss
- Being tested
- Distortion product otoacoustic emissions (DPOAE)
- Keywords
- Hearing changes, Non-surgical ear, Hearing loss, Vibration exposure, Skull-based surgery, Un-operated ear
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distortion product otoacoustic emissions (DPOAE)Diagnostic test
Also called Electrocochleaography/Electrophysiological testing, Tympanometry, Audiometry
Audiometry for extended high frequencies, DPOAE, and, ECochG measurements will be collected before and after skull-based surgeries.
| Study group | Role | What they receive |
|---|---|---|
| Participants scheduled to undergo skull-based surgery | Participants scheduled to undergo skull-based or mastoid surgery as part of their standard care will receive Audiometry for extended high frequencies, DPOAE, ECochG before and after the procedure in the non operated ear. Receives: Diagnostic Test: Distortion product otoacoustic emissions (DPOAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with a Difference of 5 dB or more between Pre- and Post-surgery DPOAE Measurements at any Frequency
DPOAE measurement using Interacoustics Titan DPOAE440 measurement tool is 5dB or greater from pre-surgery measurement to post-surgery measurement
Measured: pre-surgery, immediately after surgery, up to one month after surgery
Number of Participants with No change between Pre- and Post-surgery DPOAE Measurements
DPOAE measurement using interacoustics titan measurement tool has not changed or is less than 5dB from pre-surgery measurement to post-surgery measurement
Measured: pre-surgery, immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Sep 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Why it stopped: COVID protocols caused extreme delays.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gateway Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Partha Thirumala, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322747
- Sponsor's protocol ID
- 19090236
- Other IDs
- 3R41DC017406-01S1
- Status last verified
- Aug 2022
- First submitted
- 18 Mar 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baradaranfar MH, Shahbazian H, Behniafard N, Atighechi S, Dadgarnia MH, Mirvakili A, Mollasadeghi A, Baradaranfar A. The effect of drill-generated noise in the contralateral healthy ear following mastoid surgery: The emphasis on hearing threshold recovery time. Noise Health. 2015 Jul-Aug;17(77):209-15. doi: 10.4103/1463-1741.160691.
PubMed 26168951
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Changes After Skull Base and Mastoid Surgery
- ClinicalTrials.gov ID
- NCT04322747
- Acronym / sponsor ID
- 19090236
- Conditions
- Hearing Loss
- Keywords
- Hearing changes, Non-surgical ear, Hearing loss, Vibration exposure, Skull-based surgery, Un-operated ear
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID protocols caused extreme delays.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gateway Biotechnology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Pittsburgh
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 26 Mar 2020 (actual)
- 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.
The purpose of this study is to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the ear contralateral to the surgical site during skull-based surgeries
Detailed description
High-speed drills that are capable of producing elevated levels are used during skull based surgeries (Hilmi et al., 2011; Yu et al., 2014). Recently, it has been shown that surgical drilling may have a temporary effect on the amplitude of the otoacoustic emissions of the ear contralateral to the surgical site (Baradaranfar et al., 2015; Shenoy et al., 2015), however the temporary effects of surgical noise or vibration on the hearing of the non-surgical related ear needs to be better quantified. This study aims to to measure the potential effects of surgical drilling noise and/or vibration exposure on the hearing in the non operative ear, during surgical site during skull-based or mastoid surgeries. As part of the study patient will receive Audiometry for extended high frequencies, DPOAE, ECochG before and after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants scheduled to undergo skull-based surgery | – | Diagnostic Test: Distortion product otoacoustic emissions (DPOAE)Participants scheduled to undergo skull-based or mastoid surgery as part of their standard care will receive Audiometry for extended high frequencies, DPOAE, ECochG before and after the procedure in the non operated ear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants scheduled to undergo skull-based and mastoid surgery
Key inclusion criteria (2 listed)
- participants are undergoing a skull-based or mastoid surgery for treatment of an affected ear
- participants have normal or near-normal hearing thresholds in the un-operated ear
Key exclusion criteria (3 listed)
- participants have hearing loss (PTA > 40 dB HL) in pure tone audiometry testing before surgery in the un-operated ear
- participants have medical conditions after the surgery which prevents having hearing tests
- participants have abnormal tympanometric results
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 |
|---|---|---|
| Distortion product otoacoustic emissions (DPOAE)Also: Electrocochleaography/Electrophysiological testing, Tympanometry, AudiometryAudiometry for extended high frequencies, DPOAE, and, ECochG measurements will be collected before and after skull-based surgeries. | Diagnostic test | Participants scheduled to undergo skull-based surgery |
Primary outcome
Number of Participants with a Difference of 5 dB or more between Pre- and Post-surgery DPOAE Measurements at any Frequency
Time frame: pre-surgery, immediately after surgery, up to one month after surgery
DPOAE measurement using Interacoustics Titan DPOAE440 measurement tool is 5dB or greater from pre-surgery measurement to post-surgery measurement
Number of Participants with No change between Pre- and Post-surgery DPOAE Measurements
Time frame: pre-surgery, immediately after surgery
DPOAE measurement using interacoustics titan measurement tool has not changed or is less than 5dB from pre-surgery measurement to post-surgery measurement
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 26168951Baradaranfar MH, Shahbazian H, Behniafard N, Atighechi S, Dadgarnia MH, Mirvakili A, Mollasadeghi A, Baradaranfar A. The effect of drill-generated noise in the contralateral healthy ear following mastoid surgery: The emphasis on hearing threshold recovery time. Noise Health. 2015 Jul-Aug;17(77):209-15. doi: 10.4103/1463-1741.160691.
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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.
Partha Thirumala, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Gateway Biotechnology, Inc. at 1 site in United States.
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 3 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: withdrawn, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of Participants with a Difference of 5 dB or more between Pre- and Post-surgery DPOAE Measurements at any Frequency (time frame: pre-surgery, immediately after surgery, up to one month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04322747, which also lists 1 linked publication.
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 9 Aug 2022; AzTrials last refreshed its copy on 26 Oct 2026.