Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000682842
Ethics application status
Approved
Date submitted
26/06/2012
Date registered
26/06/2012
Date last updated
14/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of an ‘active’ hearing conservation device and its application to noise exposure management amongst noise exposed orchestral musicians.
Scientific title
A trial of an ‘active’ hearing conservation device and its application to noise exposure management amongst noise exposed orchestral musicians.
Secondary ID [1] 280733 0
Nil
Universal Trial Number (UTN)
U1111-1132-1133
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing conservation solutions amongst orchestral musicians 286782 0
Condition category
Condition code
Ear 287094 287094 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A trial of an active hearing conservation device for and its applicability for use with professional orchestral musicians. The device is worn in both ears within a custom-moulded soft silicone shell and is easily insertable/removable by the musician.
The study will be undertaken both with musicians working in the field during their normal playing activities and under controlled conditions, allowing both subjective and objective assessment. Subjects wearing the device are requested to use the device at least once during each program their orchestra undertakes during the four week trial.
Intervention code [1] 285162 0
Prevention
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287416 0
Primary outcome: device is effective at reducing sound to a safe level while still allowing most (>70% of sample) musicians to work to a professional standard.

Outcomes will be assessed through interview, a series of brief (non-validated) questionnaires (3) and a usage log completed by each subject.
Timepoint [1] 287416 0
Questionnaires will be distributed at the commencement of the trial, at two weeks and again at the conclusion of the trial. Interviews will take place two weeks into the trial.

Completion of project will occur one year from trial commencement
Secondary outcome [1] 298103 0
Device is capable of delivering undistorted sound to the ear in a non-linear fashion.
This outcome will be assessed using a combination of standard audiological 'real-ear' insertion loss techniques and coupler/test box based assessments. Results will be compared to manufacturer's claims.
Timepoint [1] 298103 0
This outcome will be assessed in a selection (6) of participants at the commencement of the trial.

This outcome will be completed three months from commencement of trial.

Eligibility
Key inclusion criteria
Full-time professional orchestral musicians at either the Queensland Symphony Orchestra or the Australian Opera and Ballet Orchestra
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Casual or short-term contract employees or those not employed by either organisation

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2012
Actual
2/11/2012
Date of last participant enrolment
Anticipated
Actual
17/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 5418 0
2010
Recruitment postcode(s) [2] 10659 0
4101 - West End

Funding & Sponsors
Funding source category [1] 285523 0
Government body
Name [1] 285523 0
The Australian Research Council
Country [1] 285523 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Cumberland campus,
75 East St,
Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 284359 0
None
Name [1] 284359 0
Address [1] 284359 0
Country [1] 284359 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287534 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 287534 0
Ethics committee country [1] 287534 0
Date submitted for ethics approval [1] 287534 0
06/07/2012
Approval date [1] 287534 0
12/09/2012
Ethics approval number [1] 287534 0
14952

Summary
Brief summary
This project involves an investigation amongst noise-exposed professional orchestral musicians into the usability of an electronic hearing protection device. The device is specifically designed for musicians and apparently capable of delivering hi-fidelity sound to the ear at a level that will protect the wearer from noise-induced hearing loss in a performance or rehearsal setting. Twenty-four musicians selected from two professional orchestras will be fitted with the device and be closely monitored for both their reaction to and their use of the device over a period of four weeks during ‘at-risk’ activities. The actual attenuation provided by the device will be determined in each subject using standard audiological test techniques. The device will also be subjected to laboratory testing to determine if manufacturer’s claims of attenuation and fidelity are reproducible.
Trial website
Trial related presentations / publications
O'Brien, I., Driscoll, T., Williams, W., & Ackermann, B. (2014). A Clinical Trial of Active Hearing Protection for Orchestral Musicians. Journal of Occupational and Environmental Hygiene, 11, 450–459. http://doi.org/10.1080/15459624.2013.875187
Public notes

Contacts
Principal investigator
Name 34362 0
Dr Bronwen Ackermann
Address 34362 0
THE UNIVERSITY OF SYDNEY
L115, Cumberland Campus C42
East St (PO Box 170) Lidcombe NSW 1825
Country 34362 0
Australia
Phone 34362 0
+61 2 9351 9472
Fax 34362 0
Email 34362 0
[email protected]
Contact person for public queries
Name 17609 0
Dr Ian OBrien
Address 17609 0
14 Kingwell St
Moorooka QLD 4105
Country 17609 0
Australia
Phone 17609 0
+61 (0)403 184 373
Fax 17609 0
Email 17609 0
[email protected]
Contact person for scientific queries
Name 8537 0
Dr Ian OBrien
Address 8537 0
14 Kingwell St
Moorooka QLD 4105
Country 8537 0
Australia
Phone 8537 0
+61 (0)403 184 373
Fax 8537 0
Email 8537 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.