The primary objective of this study is to answer the question whether the obliteration of an open cavity mastoid restores the subjective sound quality as perceived in the particular ear. The secondary objective is to determine the differences in…
ID
Source
Brief title
Condition
- External ear disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the subjective preference of the subjects for the
sound quality as perceived by a normal ear canal versus an open cavity mastoid,
and by a normal ear canal versus an obliterated mastoid cavity.
Secondary outcome
-
Background summary
In individual cases, patients have reported a change in the subjective sound
quality after mastoidectomy or after obliteration of the mastoid cavity. These
changes in sound quality depend on the acoustical properties of the outer ear.
The acoustical properties can be characterized by standard clinical procedures
as the measurement of the Real Ear Unaided Response (REUR) and the Real Ear to
Coupler Difference (RECD). The hypothesis is that the ear canal acoustical
properties and the subjective sound quality mainly depend on the total volume
of the ear canal and the additional volume of a mastoid cavity. Since an
obliteration of the mastoid cavity more or less restores the original volume of
the outer ear canal, the procedure of obliteration should be able to restore
the subjective quality of sound.
Study objective
The primary objective of this study is to answer the question whether the
obliteration of an open cavity mastoid restores the subjective sound quality as
perceived in the particular ear. The secondary objective is to determine the
differences in RECD and REUR between normal ears, ears with open cavity
mastoids and ears with obliterated mastoid cavities.
Study design
An observational study including two groups of subjects, one with unilateral
open cavity mastoids and one with unilateral obliterated mastoid cavities. By
simulation of the different outer ear canal acoustics using the inter aural
differences in RECD, a double blind investigation of the subjects preferences
in sound quality can be performed in both the normal ear as in the pathological
ear. During one visit of about 2.5 hours, the hearing capacity and external ear
acoustic properties are characterized using standard clinical tests. In
addition, a subjective comparison category rating is included to determine the
individual preferences in sound quality.
Study burden and risks
Since this study is observational, the burden for the patients is minimal.
Several tests similar or equal to those done in standard clinical practice will
be done during one visit. The primary outcome of the study aims to give more
information about the effects of the obliteration of open cavity mastoid ears
on the subjective perception of sound. This is relevant for patients who
consider to undergo an obliteration of an open cavity mastoid, in addition to
the medical considerations.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Aged 18 years or older.
- Single sided open cavity mastoid, or a single sided obliterated mastoid, with
pure tone hearing thresholds of 70 dB(HL) or better for all audiometric
frequencies between 250 and 8000 Hz.
- Normal external ear properties in the contralateral ear, with no history of
middle ear or mastoid surgery, and pure tone hearing thresholds of 20 dB(HL) or
better for all audiometric frequencies between 250 and 8000 Hz.
- Sufficient knowledge of the Dutch language, both spoken and written, in order
to being able to participate in the perceptual evaluation experiment.
Exclusion criteria
- Pure tone hearing thresholds do not meet the specified criteria.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42243.018.12 |