UNification of Treatments and Interventions for TInnitus Patients - Randomized Clinical Trial (UNITI-RCT)

NCT04663828 | Completed DMC

• 1 other identifier: UNITI
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The study includes a 12-week treatment trial for chronic tinnitus patients using 4 different types of interventions (hearing aids, sound therapy, structured counseling, cognitive behavioral therapy) either as a single treatment or a combination of two treatments. There are several aims of the study: compare 1) single vs. combined treatments, 2) single treatments vs. other treatments, 3) ear and brain based interventions, 4) analyzing data of the clinical trial in combination with other recorded data (genetic and proteomic data, audiology data) to develop in silico models of tinnitus and a decision support system with the aim to aid in treatment decisions. This randomized controlled trial is harmonized over five clinical centers in Europe with the aim to include 100 patients per center and is part of the UNITI-project (UNification of treatments and Interventions for TInnitus patients) funded by the European Union's Horizon 2020 programme (grant agreement number 848261).

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• The effects of interventions in tinnitus distress

  The primary outcome will cover the domain tinnitus distress. The total score in the Tinnitus Handicap Inventory (THI; Newman et al., (1996)) is defined as the primary outcome measure for tinnitus distress.

  Through study completion, an average of 22 months

Study Arms (10)

Structured counseling

OTHER

Patients will receive a structured counseling therapy

Other: Structured counseling

Hearing Aids

OTHER

Patients will receive hearing aids support

Device: Hearing aids

Cognitive behavioral therapy

OTHER

Patients will receive cognitive behavioral therapy

Other: Cognitive behavioral therapy

Sound therapy

OTHER

Patients will follow a sound therapy program

Other: Sound therapy

Combination of sound therapy and cognitive behavioral therapy

OTHER

Patients will receive a combination of sound therapy and cognitive behavioral therapy

Other: Cognitive behavioral therapy; Other: Sound therapy

Combination of hearing aids and cognitive behavioral therapy

OTHER

Patients will receive a combination of hearing aids and cognitive behavioral therapy

Device: Hearing aids; Other: Cognitive behavioral therapy

Combination of hearing aids and structured counseling

OTHER

Patients will receive a combination of hearing aids and structured counseling

Other: Structured counseling; Device: Hearing aids

Combination of structured counseling and sound therapy

OTHER

Patients will receive a combination of structured counseling and sound therapy

Other: Structured counseling; Other: Sound therapy

Combination of hearing aids and sound therapy

OTHER

Patients will receive a combination of hearing and sound therapy

Device: Hearing aids; Other: Sound therapy

Combination of cognitive behavioral therapy and sound therapy

OTHER

Patients will receive a combination of cognitive behavioral therapy and sound therapy

Other: Cognitive behavioral therapy; Other: Sound therapy

Interventions

Structured counseling OTHER

Structured patient education and counselling is considered as providing information to patients in order to empower them to better manage their disorder

Combination of hearing aids and structured counseling; Combination of structured counseling and sound therapy; Structured counseling

Hearing aids DEVICE

Hearing aids are considered medical devices and are recommended to patients with a certain degree of hearing loss. Hearing aids amplify environmental sounds.

Combination of hearing aids and cognitive behavioral therapy; Combination of hearing aids and sound therapy; Combination of hearing aids and structured counseling; Hearing Aids

Cognitive behavioral therapy OTHER

This is a structured intervention and consists of a several week program both with noise exposure and structured interviews and expert-patient as well as patient-patient interaction in groups

Cognitive behavioral therapy; Combination of cognitive behavioral therapy and sound therapy; Combination of hearing aids and cognitive behavioral therapy; Combination of sound therapy and cognitive behavioral therapy

Sound therapy OTHER

Several sounds and music are used for tinnitus disorder

Combination of cognitive behavioral therapy and sound therapy; Combination of hearing aids and sound therapy; Combination of sound therapy and cognitive behavioral therapy; Combination of structured counseling and sound therapy; Sound therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary complaint tinnitus
• Chronic tinnitus (for at least 6 months based on history)
• Age 18-80 years
• Ability to understand and consent to the research / ability to participate (hearing ability, intellectual capacity, no plans for sabbaticals or long-term holidays, no (plans for) pregnancy)
• A score of \>22 on the Montreal Cognitive Assessment (MoCa), i.e. adults without mild cognitive impairment
• Ability and willingness to use the UNITI mobile applications on their smartphones
• A score of ≥ 18 in the Tinnitus Handicap Inventory (THI) of Newman et al. (1996)
• Willing to use a hearing aid (if indication)

You may not qualify if:

• Objective tinnitus / heartbeat-synchronous tinnitus as primary complaint
• Start of any other tinnitus related treatments, especially hearing aids, structured counseling, sound therapy (with special devices; expecting long term effects) or cognitive behavioral therapy in the last 3 months before the start of the study
• Otosclerosis / acoustic neuroma or other relevant ear disorders with fluctuation hearing
• Present acute infections (acute otitis media, otitis externa, acute sinusitis)
• Meniere's disease or similar syndromes (but not vestibular migraine)
• Serious internal, neurological or psychiatric conditions
• Epilepsy or other CNS disorders (brain tumor, encephalitis)
• Clinically relevant drug, medication or alcohol abuse up to 12 weeks before study start
• Missing written informed consent
• Severe hearing loss - inability to communicate properly in the course of the study
• One deaf ear

Sponsors & Collaborators

• UNITI Consortium: lead
• University Hospital Regensburg: collaborator
• University Hospital Virgen de las Nieves: collaborator
• Hospital Clinico Universitario San Cecilio: collaborator
• Charite University, Berlin, Germany: collaborator
• National and Kapodistrian University of Athens: collaborator
• KU Leuven: collaborator

Study Sites (1)

Tinnituszentrum Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Related Publications (3)

• Schoisswohl S, Langguth B, Schecklmann M, Bernal-Robledano A, Boecking B, Cederroth CR, Chalanouli D, Cima R, Denys S, Dettling-Papargyris J, Escalera-Balsera A, Espinosa-Sanchez JM, Gallego-Martinez A, Giannopoulou E, Hidalgo-Lopez L, Hummel M, Kikidis D, Koller M, Lopez-Escamez JA, Marcrum SC, Markatos N, Martin-Lagos J, Martinez-Martinez M, Martinez-Martinez M, Ferron MM, Mazurek B, Mueller-Locatelli N, Neff P, Oppel K, Perez-Carpena P, Robles-Bolivar P, Rose M, Schiele T, Schiller A, Simoes J, Stark S, Staudinger S, Stege A, Verhaert N, Schlee W. Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial. Trials. 2021 Dec 4;22(1):875. doi: 10.1186/s13063-021-05835-z.

  PMID: 34863270 BACKGROUND

• Simoes JP, Schoisswohl S, Schlee W, Basso L, Bernal-Robledano A, Boecking B, Cima R, Denys S, Engelke M, Escalera-Balsera A, Gallego-Martinez A, Gallus S, Kikidis D, Lopez-Escamez JA, Marcrum SC, Markatos N, Martin-Lagos J, Martinez-Martinez M, Mazurek B, Vassou E, Jarach CM, Mueller-Locatelli N, Neff P, Niemann U, Omar HK, Puga C, Schleicher M, Unnikrishnan V, Perez-Carpena P, Pryss R, Robles-Bolivar P, Rose M, Schecklmann M, Schiele T, Schobel J, Spiliopoulou M, Stark S, Vogel C, Wunder N, Zachou Z, Langguth B. The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT). Trials. 2023 Jul 24;24(1):472. doi: 10.1186/s13063-023-07303-2.

  PMID: 37488627 BACKGROUND

• Schoisswohl S, Basso L, Simoes J, Engelke M, Langguth B, Mazurek B, Lopez-Escamez JA, Kikidis D, Cima R, Bernal-Robledano A, Bocking B, Bulla J, Cederroth CR, Crump H, Denys S, Escalera-Balsera A, Gallego-Martinez A, Gallus S, Goedhart H, Hidalgo-Lopez L, Jarach CM, Kader H, Koller M, Lugo A, Marcrum SC, Markatos N, Martin-Lagos J, Martinez-Martinez M, Muller-Locatelli N, Neff P, Niemann U, Perez-Carpena P, Pryss R, Puga C, Robles-Bolivar P, Rose M, Schecklmann M, Schiele T, Schleicher M, Schobel J, Spiliopoulou M, Stark S, Staudinger S, Stege A, Todtli B, Trochidis I, Unnikrishnan V, Vassou E, Verhaert N, Vogel C, Zachou Z, Schlee W. Single versus combination treatment in tinnitus: an international, multicentre, parallel-arm, superiority, randomised controlled trial. Nat Commun. 2025 Nov 21;16(1):10510. doi: 10.1038/s41467-025-66165-1.

  PMID: 41271763 DERIVED

Related Links

• Publication of study protocol
• Publication of Statistical Analysis Plan SAP

MeSH Terms

Conditions

Tinnitus

Interventions

Hearing Aids; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Four different types of interventions will be included in the RCT. Two of them mainly target on the auditory aspects of tinnitus (hearing aid fitting and sound therapy), whereas the other two mainly target the CNS (Structured Counselling and Cognitive Behavioral Therapy).

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: April 16, 2021
• Primary Completion: December 19, 2022
• Study Completion: June 15, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)