To quantify the tinnitus relief provided by CART sound therapy.
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the change in VAS-scores (Visual Analog Scale) on
tinnitus loudness and annoyance and the change in the score on the Tinnitus
Functional Index (TFI) between baseline and intervention.
Secondary outcome
Secondary parameters are the ratings on the acceptability of CART sounds,
(Serious) Adverse Event reporting and speech perception tests with CART on and
off.
Background summary
Sound enrichment therapy is a well-established therapy for patients suffering
from tinnitus (Hoare et al, 2014, Sereda et al 2016). Studies show that
electrical stimulation independent of environmental sounds provided via CI
suppresses tinnitus significantly (Dauman et al., 1993; Rubinstein et al.,
2003; Chang et al., 2010, 2012; Reavis et al., 2010, Zeng et al., 2011; Arts et
al., 2015a, 2015b, 2016a, 2016b). Tyler and colleagues (2015) investigated the
effect on tinnitus of background sound generated by a cable connected MP3
player and mixed with the microphone input of the CI. They reported on a series
of case studies including six patients and concluded that mixed stimulation can
be effective for suppressing tinnitus. The aim of this study is to investigate
whether streaming of background sounds directly via the Sound Processor of the
cochlear implant system making use of CART sound therapy can provide relief
from tinnitus in cochlear implant users with tinnitus. The background sounds
provided by CART are mixed with the signal picked up by the microphone of the
CI to assure accurate environmental sound and speech perception during
background stimulation.
Study objective
To quantify the tinnitus relief provided by CART sound therapy.
Study design
Prospective, exploratory, repeated measures clinical trial.
Intervention
CART sound therapy.
Study burden and risks
This study consists of two phases. The expected duration of phase 1 is about 2
hours after which the participants will have the opportunity to move on to
phase 2. The expected duration of phase 2 is about 7 weeks, including two
visits to the clinic. All visits will last about two hours. Subjects are
advised to use CART sound therapy continuously during the day, but they are
free to change the volume. During the study patient diaries and questionnaires
must be completed and one speech perception test will be performed. All CART
sounds will be applied using the standard CI remaining well within its
conventional clinical safety limits. Therefore, the risks associated with
participation is estimated to be low.
The potential benefit of participation is that participants become aware of
sound therapy through the CI in general. This can help to gain better control
of the tinnitus after participation in the study. It is expected that the CART
algorithm will increase users* comfort compared to sound enrichment generated
by a cable connected MP3 player. Moreover less battery consumption is expected
compared to wireless streaming via commercially available sound enrichment
tools.
Peter Merian-Weg 4
Basel 4052
CH
Peter Merian-Weg 4
Basel 4052
CH
Listed location countries
Age
Inclusion criteria
Self-reported tinnitus during standard cochlear implant use.
Exclusion criteria
History of psychiatric disorders or depression (on investigator*s opinion).
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 |
|---|---|
| ClinicalTrials.gov | NCT03026829 |
| CCMO | NL58657.068.17 |