The objectives of this study are to evaluate the clinical outcome of a cochlear implant (CI) over standard health care therapy with either BAHA or CROSS in patients with SSD and to examine the cost efficiency of cochlear implantation in these…
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Performance on USTARR speech in noise test (see C1)
Secondary outcome
- Performance on the Standard Dutch phoneme test (NvA-list)
- Speech intelligibility test with spatially separated sources
- Crescent of sound test, for sound localization
- Speech, Spatial and Qualities of hearing scale (SSQ); questionaire to
objectify several domains of hearing
- Health Utilities Index (HUI3): questionnaire for general quality of life
- Glasgow Benefit Inventory (GBI); questionnaire for general quality of life
after surgery
- Abbreviated Profile of Hearing Aid Benefit (APHAB); questionnaire for quality
of hearing on several subdomains
- Time Trade Off (TTO); quality of life question
- Visual Analogue Scale (VAS); questionnaire on quality of life and hearing
- EuroQol5D; questionnaire on quality of life
- Hospital Anxiety and Disorder Scale (HADS); questionnaire objectifying
anxiety and depression
- Tinnitus Handicap Inventory (THI): tinnitus questionnaire
- Tinnitus Questionnaire (TQ): tinnitus questionnaire
- Tinnitus Burden Questionnaire (TBQ); tinnitus questionnaire
- Cost diary for cost utility analysis
- CI-patients: vocoder and pitch match experiments
Background summary
Patients who develop single-sided deafness (SSD) become aware of the importance
of hearing with two ears in everyday listening environments. Current clinical
practice for patients with SSD consists of optimizing hearing using a Bone
Anchored Hearing Aid (BAHA) or a Contralateral Routing of Sound System (CROSS).
With both devices sound awareness on the deafened side can be improved, but
they do not provide bilateral auditory input, which is needed to achieve the
actual benefits of hearing with two ears. These limitations may be overcome by
providing a cochlear implant (CI) and consequently generating auditory input to
the affected ear. This study will investigate the benefit of cochlear
implantation versus treatment with BAHA or CROSS in patients with SSD. CI
patients will be able to compare sounds in their CI ear to sounds in their
normal hearing ear, enabling us to perform pitch match and vocoder experiments
(see C1).
Study objective
The objectives of this study are to evaluate the clinical outcome of a cochlear
implant (CI) over standard health care therapy with either BAHA or CROSS in
patients with SSD and to examine the cost efficiency of cochlear implantation
in these patients. In CI patients pitch match and vocoder experiments will be
performed.
Study design
120 subjects with acute (>=3 months and <=10 years since onset) SSD will be
included in this Randomised Controlled Trial (RCT). 30 Subjects shall receive a
CI on the deaf side after randomisation (Group A). The other 90 subjects shall
start with a 6-week during test period with either a BAHA on a headband (n =
45, Group B) or with a CROSS (n = 45, Group C). After these 6 weeks, patients
in group B switch to a test period with a CROSS for 6 weeks and vice versa for
patients in group C. After completing both test periods patients in group B and
group C will choose for further treatment with a CROSS, a definitive surgically
implanted BAHA or no treatment. The follow- up sessions will take place 3, 6,
12, 18, 24, 36, 48 and 60 months after randomisation for participants in all
groups.
Intervention
Cochlear Implantation versus BAHA or CROSS
Study burden and risks
The study is considered a non-significant risk evaluation of routine modalities
for SSD in clinical practice (BAHA and CROSS) compared to a modality, cochlear
implantation, which is already commonly clinically applied in patients with
bilateral hearing loss. The evaluation consists of 7 test sessions of 2 hours
each, spread out over five years of time, excluding the cost diary.
adverse events:
- standard risks associated with cochlear implantation or BAHA-placement
- standard risks associated with general anaesthesia
- associated with CI and BAHA: implant failure, irritation, pain, infection,
implant extrusion
- associated with CI (following electrical stimulation): tinnitus, facial nerve
stimulation, dizziness, uncomfortably loud sound sensation or no sound
sensation due to failure of implant (components).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Age 18 or older.
- Acute onset of postlingual SSD, defined as onset unilateral hearing loss between >=3 months and <=10 years before time of inclusion.
- Hearing measurements:
> Pure Tone Audiometry of the deaf ear, defined as thresholds of 70 dB or higher on frequencies 0,5 - 4.0 kHz (average).
> Normal hearing on the contralateral ear, defined as pure tone audiometry thresholds of 30 dB or less on frequencies 0.5 - 4.0 kHz (average).
> Air bone gap 10 dB or smaller.
- Normal function of middle ear (i.e. no acute middle ear infections or tympanic membrane perforations).
- Dutch language proficiency.
- Willingness and ability to participate in all scheduled procedures outlined in the protocol.
- General health allowing general anaesthesia for the potential surgical implantation of a CI or BAHA.
- Patients covered by the Dutch health insurance.
- Patients should agree to be implanted with a CI or BAHA.
- Informed consent understood, filled out and signed by patient.
- Patients are not allowed to participate in another ongoing research study related to SSD or cochlear implantation
Exclusion criteria
- previous experience with implanted BAHA or CI
- retrocochlear pathology
- abnormal cochlear anatomy in one or both ears (i.e. ossification)
- disability which could interfere with the completion of the tests (i.e. psychiatric problems or severe comorbidity with an expected survival of less than five years)
Design
Recruitment
Medical products/devices used
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 | NL45288.041.13 |
| Other | trialregister.nl, NTR4580 |