Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial

Επιστημονική δημοσίευση - Άρθρο Περιοδικού uoadl:3033343 34 Αναγνώσεις

Μονάδα:
Ερευνητικό υλικό ΕΚΠΑ
Τίτλος:
Unification of Treatments and Interventions for Tinnitus Patients
(UNITI): a study protocol for a multi-center randomized clinical trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background: Tinnitus represents a relatively common condition in the
global population accompanied by various comorbidities and severe burden
in many cases. Nevertheless, there is currently no general treatment or
cure, presumable due to the heterogeneity of tinnitus with its wide
variety of etiologies and tinnitus phenotypes. Hence, most treatment
studies merely demonstrated improvement in a subgroup of tinnitus
patients. The majority of studies are characterized by small sample
sizes, unstandardized treatments and assessments, or applications of
interventions targeting only a single organ level. Combinatory treatment
approaches, potentially targeting multiple systems as well as treatment
personalization, might provide remedy and enhance treatment responses.
The aim of the present study is to systematically examine established
tinnitus therapies both alone and in combination in a large sample of
tinnitus patients. Further, it wants to provide the basis for
personalized treatment approaches by evaluating a specific decision
support system developed as part of an EU-funded collaborative project
(Unification of treatments and interventions for tinnitus patients;
UNITI project).
Methods/study design: This is a multi-center parallel-arm randomized
clinical trial conducted at five different clinical sites over the EU.
The effect of four different tinnitus therapy approaches (sound therapy,
structured counseling, hearing aids, cognitive behavioral therapy)
applied over a time period of 12 weeks as a single or rather a
combinatory treatment in a total number of 500 chronic tinnitus patients
will be investigated. Assessments and interventions are harmonized over
the involved clinical sites. The primary outcome measure focuses on the
domain tinnitus distress assessed via the Tinnitus Handicap Inventory.
Discussion: Results and conclusions from the current study might not
only provide an essential contribution to combinatory and personalized
treatment approaches in tinnitus but could also provide more profound
insights in the heterogeneity of tinnitus, representing an important
step towards a cure for tinnitus.
Έτος δημοσίευσης:
2021
Συγγραφείς:
Schoisswohl, Stefan
Langguth, Berthold
Schecklmann, Martin and
Bernal-Robledano, Alberto
Boecking, Benjamin
Cederroth,
Christopher R.
Chalanouli, Dimitra
Cima, Rilana
Denys, Sam
and Dettling-Papargyris, Juliane
Escalera-Balsera, Alba and
Espinosa-Sanchez, Juan Manuel
Gallego-Martinez, Alvaro and
Giannopoulou, Efi
Hidalgo-Lopez, Leyre
Hummel, Michael and
Kikidis, Dimitris
Koller, Michael
Lopez-Escamez, Jose A. and
Marcrum, Steven C.
Markatos, Nikolaos
Martin-Lagos, Juan and
Martinez-Martinez, Maria
Martinez-Martinez, Marta
Ferron, Maria
Mata
Mazurek, Birgit
Mueller-Locatelli, Nicolas
Neff,
Patrick
Oppel, Kevin
Perez-Carpena, Patricia
Robles-Bolivar,
Paula
Rose, Matthias
Schiele, Tabea
Schiller, Axel and
Simoes, Jorge
Stark, Sabine
Staudinger, Susanne
Stege,
Alexandra
Verhaert, Nicolas
Schlee, Winfried
Περιοδικό:
Trials
Εκδότης:
BMC
Τόμος:
22
Αριθμός / τεύχος:
1
Λέξεις-κλειδιά:
Tinnitus; Treatment; Hearing aids; Cognitive behavioral therapy; Sound
therapy; Structured counseling; Multi-center; RCT
Επίσημο URL (Εκδότης):
DOI:
10.1186/s13063-021-05835-z
Το ψηφιακό υλικό του τεκμηρίου δεν είναι διαθέσιμο.