Clinical trial NCT05245318: The CATT Trial: Cost-effectiveness of a Smartphone Application for Tinnitus Treatment
Official title: Cost-effectiveness of a Smartphone Application for Tinnitus Treatment (The CATT Trial): A Study Protocol of a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: somatic tinnitus
smartphone application
telerehabilitation
blended physiotherapy program
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: University Hospital, Antwerp
name: University of Regensburg
First posted: 2022-02-17
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed as a single-blind two-arm 1:1 randomised controlled trial. The study is designed as a non-inferiority trial of a continuous response variable comparing independent control and experimental subjects. After baseline measurements, patients will be randomised into either the experimental group or the control group. A stratified randomisation according to the grade of tinnitus severity obtained by use of the Tinnitus Functional Index (TFI) and gender will be used. A minimisation procedure will be used to perform the stratified randomisation using the web-based online randomisation tool Qminim.
Primary purpose: TREATMENT

Brief summary: The twofold aim of this single-blind two-arm 1:1 randomised control trial is to examine if the treatment effect and cost-effectiveness of a smartphone application, designed to increase therapy compliance and provide tinnitus counselling, as part of a blended physiotherapy program, is, as hypothesised, as good as or better in comparison to standard clinical care.

Detailed description: Background: Tinnitus is a highly prevalent symptom with a variety of possible underlying diseases, affecting 10-15% of the adult population. Apart from the heterogenous clinical origin, it is also characterised by a diverse clinical representation, often causing distress and interfering with daily functioning and quality of life. In case the tinnitus is influenced by alterations in somatosensory afference from the cervical spine or temporomandibular area, due to increased muscle tension or movement restrictions, it is referred to as somatic or somatosensory tinnitus (ST). ST is known to react well to physiotherapy treatment, but currently, it is hard to motivate patients to do their home exercises properly and the necessary tinnitus counselling is often lacking.

Objective: The twofold aim of this study is to examine if the treatment effect and cost-effectiveness of a smartphone application, designed to increase therapy compliance and provide tinnitus counselling, as part of a blended physiotherapy program, is, as hypothesised, as good as or better in comparison to standard clinical care.

Methods and design: This study is designed as a single-blind two-arm 1:1 randomised control trial. Adult patients diagnosed with ST, without psychiatric comorbidities and with basic knowledge of the use of a smartphone, will be recruited at the Ear Nose Throat (ENT) department of the Antwerp university hospital (UZA). After inclusion and baseline measurements, patients will be randomised to one of the treatment groups. The experimental group will receive the blended physiotherapy program containing six in-clinic physiotherapy sessions over a period of twelve weeks (1x/2weeks) and access to the exercise and counselling program provided by the smartphone application. The control group will receive the standard care physiotherapy program comprising twelve weekly in-clinic physiotherapy sessions. As a primary outcome measure, the change in Tinnitus Functional Index (TFI) score at 1 month after the last treatment will be used. Secondary outcome measures are the visual analogue scale (VAS) for tinnitus loudness, Neck Bournemouth Questionnaire (NBQ), Temporomandibular disorder (TMD) pain screener, clinical neck and jaw tests, pure tone audiometry, speech-in-quiet (SPIQ) and speech-in-noise (SPIN) understanding, psychoacoustic tinnitus measures (tinnitus pitch and loudness matching), the Hospital Anxiety and Depression Scale (HADS), the Hyperacusis Questionnaire (HQ). Additionally, a cost-effectiveness analysis will be performed informing on both medical costs and indirect costs. Data from the Euroqol EQ-5D and iMTA Productivity Cost Questionnaire (PCQ) will be used in this analysis. Data for all outcome measures will be collected at baseline, one month after the last treatment session and three months after the last treatment session.

Discussion: This is the first study to combine both tinnitus counselling and neck/jaw pain treatment provided by a digital application in a blended physiotherapy program. This is in order to empower ST patients to improve and better manage their own health and possibly reduce economic costs by alleviating the tinnitus burden ST patients experience. The advantages of this single-blind two-arm randomised controlled trial are the high-quality methodological design, the great sample size and the expertise of the research team.

Eligibility criteria: Inclusion Criteria:

* Adults (+ 18 years old) with Somatic tinnitus (ST), diagnosed according to the diagnostic criteria for ST
* Fluent in Dutch
* Own smartphone and able to use common applications without support

Exclusion Criteria:

* Other types of tinnitus
* Active middle ear pathology
* An active psychiatric disorder (such as anxiety disorder or clinical depression) diagnosed by the psychiatric team of Antwerp University Hospital

Primary outcomes:
measure: Change in Tinnitus Functional Index (TFI)
timeFrame: from baseline to one month follow-up (also tested after last treatment session and at three months follow-up)
Secondary outcomes:
measure: Cervical spine mobility
timeFrame: from baseline to one and three months follow-up
measure: Joint Repositioning Accuracy (JRA)
timeFrame: from baseline to one and three months follow-up
measure: Strength of deep neck flexors
timeFrame: from baseline to one and three months follow-up
measure: Coordination of deep neck extensors
timeFrame: from baseline to one and three months follow-up
measure: Coordination of shoulder stabilizing muscles
timeFrame: from baseline to one and three months follow-up
measure: Jaw mobility
timeFrame: from baseline to one and three months follow-up
measure: Myofascial triggerpoints
timeFrame: from baseline to one and three months follow-up
measure: Pure tone hearing thresholds
timeFrame: from baseline to one and three months follow-up
measure: Speech-in-quiet (SPIQ) understanding
timeFrame: from baseline to one and three months follow-up
measure: Speech-in-noise (SPIN) understanding
timeFrame: from baseline to one and three months follow-up
measure: Tinnitus pitch matching
timeFrame: from baseline to one and three months follow-up
measure: Tinnitus Loudness matching
timeFrame: from baseline to one and three months follow-up
measure: VAS for tinnitus loudness
timeFrame: from baseline to one and three months follow-up
measure: Neck Bournemouth Questionnaire (NBQ) score
timeFrame: from baseline to one and three months follow-up
measure: Temporomandibular disorder (TMD) pain screener score
timeFrame: from baseline to one and three months follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: from baseline to one and three months follow-up
measure: Hyperacusis Questionnaire (HQ)
timeFrame: from baseline to one and three months follow-up
measure: EuroQol (EQ-5D)
timeFrame: baseline, after last treatment session and at one and three months follow-up
measure: Productivity Cost Questionnaire (iPCQ)
timeFrame: monthly between baseline and three months follow-up
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
citation: Demoen S, Jacquemin L, Timmermans A, Van Rompaey V, Vanderveken O, Vermeersch H, Joossen I, Van Eetvelde J, Schlee W, Marneffe W, Luyten J, Gilles A, Michiels S. Cost-effectiveness of a smartphone Application for Tinnitus Treatment (the CATT trial): a study protocol of a randomised controlled trial. Trials. 2022 May 23;23(1):435. doi: 10.1186/s13063-022-06378-7.