The main objective of the study is to assess the effect of a cochlear implant on tinnitus burden in patients suffering from tinnitus accompanied by hearing loss.
ID
Source
Brief title
Condition
- Hearing disorders
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome will be the difference of the tinnitus functional index (TFI)
between the intervention (CI) at 6 months after cochlear implantation (CI) and
the control group at 6 months after randomization.
Secondary outcome
Secondary outcome measures will be:
- Anxiety and Depression level: BDI, HADS
- Electrocochleography
- Hearing level: pure tone audiometry at 0.25, 0.5, 1, 1.5, 2, 4 kHz
- Hearing related QoL: SSQ
- General QoL: EQ5D
- Patient reported change: GBI and CGI
- Tinnitus severity: VAS
- Tinnitus pitch and loudness matching
- Speech recognition test in quiet and noise
The usage of CI and the hearing environment on daily average will be logged
from the sound processor.
Background summary
Tinnitus is the perception of sound without an external stimulus, often
experienced as a ringing or buzzing sound (Zeman, Koller, Schecklmann,
Langguth, & Landgrebe, 2012)(Moller, Salvi, De Ridder, Kleinjung, & Vanneste,
2015). While the underlying aetiology of tinnitus is still debated, one
hypothesis is that the tinnitus arises from changes in neural activity caused
by reduced or lack of auditory input due to hearing loss which often
accompanies the tinnitus (JJ & LE, 2017) (Moller et al., 2015). Tinnitus is a
common symptom with an approximate prevalence of 10-30%, depending on the
selected population (Møller AR, Langguth B, De Ridder D, 2010) (Davis A, 2000).
Since no curative treatment for tinnitus is available until today, symptom
reduction is the highest possible effect. This study will focus on the effect
of a cochlear implant (CI) to treat tinnitus.
Study objective
The main objective of the study is to assess the effect of a cochlear implant
on tinnitus burden in patients suffering from tinnitus accompanied by hearing
loss.
Study design
50 patients with complaints of moderate to severe tinnitus (TFI>32 and tinnitus
duration >1year) and moderate to severe hearing loss (PTA at 0.5,1,2,4 kHz:
bilateral threshold >= 40 and <= 80 dB and hearing thresholds in the ear to be
implanted (>= 4 kHz) >= 50 dB) will be included in this randomized controlled
trial (RCT) after their Informed Consent (IC). 25 patients (CI group) shall
receive a CI in the ear mostly affected by tinnitus.. The other 25 patients
(control group) shall follow the same follow up period of 6 months with no
intervention. The follow-up sessions will take place 3, and 6 months after
implantation to assess the primary outcome of tinnitus burden and secondary
outcomes of quality of life, treatment related outcomes and auditory function.
Intervention
Patients from the intervention group will be surgically implanted with a CI
from Cochlear Ltd under general anesthesia on the most tinnitus affected side.
A phase of rehabilitation and a phase of follow-up including auditory
evaluations and questionnaires will be followed by all patients from the
intervention group. Patients from the control group will have no intervention
and will follow the same auditory evaluations and questionnaires as the
intervention group.
Study burden and risks
The study is considered as a risk-benefit investigational treatment. The
cochlear implantation is a standard treatment under general anesthesia in
current clinical care in case of more severe levels of bilateral hearing loss.
In this study, individuals with moderate hearing loss are included, which
induces a risk of deterioration of hearing threshold that needs to be
considered because of the cochlear trauma during the cochlear implantation. On
the other hand, the tinnitus may benefit from cochlear implantation and result
in tinnitus suppression (Arts 2016) and may restore the hearing loss. The study
includes a series of questionnaires to be filled in at home at 2 weeks, 3 and 6
months after implantation and auditory function tests at 3 and 6 months after
implantation in the clinic (approximately two hours each).
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
• Patients aged 18 or older
• Seeking help for tinnitus
• Subjective tinnitus
• Tinnitus Functional Index (TFI) > 32
• Tinnitus duration > 1 year and subjective tinnitus stability > 6 months
• Hearing level:
o Audiometry (Pure Tone Average (PTA) at 0.5,1,2 kHz): bilateral threshold >= 40
and <= 80 dB
o Hearing thresholds in the ear to be implanted (>= 4 kHz) >= 50 dB
o Hearing threshold stability (PTA < 5 dB change for 1 year in each ear)
• Health status allows general anesthesia and surgery for the cochlear
implantation
• Failure of regular tinnitus care (e.g. psychological or sound therapy)
• Dutch language proficiency
• Willingness and ability to participate in all scheduled procedures outlined
in the protocol
• Able to understand and sign informed consent
Exclusion criteria
• Patient primary seeking help for non-tinnitus hearing problems
• Abnormal cochlear anatomy(i.e. ossification)
• Comorbidity with an expected survival of less than five years based on
medical history as assessed by clinician and in electronical patient file
• Additional handicaps that would prevent participation in the evaluations
• Presence of any instable psychiatric condition within 6 months before start
of the study
• Patient with active clinical depression within the 6 months before start of
the study
• Unrealistic expectations on the part of the patient regarding the possible
benefits, risks and limitations that are inherent to the procedure
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL70319.041.19 |
| OMON | NL-OMON23880 |