Trial Outcomes & Findings for Neuro-Music-Therapy for Patients With Chronic Tinnitus - a Controlled Clinical Trial (NCT NCT01845155)

Last Updated: 2014-03-17

Results Overview

Tinnitus severity was assessed by the German version of the tinnitus questionnaire (TQ, Goebel and Hiller 1994). The TQ consists of a total of 52 items. The questionnaire records tinnitus related complaints on a global TQ-score. The range of values is between the minimum score of 0 and the maximum score of 84, whereas high values indicate high tinnitus related distress.

Recruitment status

COMPLETED

Study phase

Target enrollment

300 participants

Primary outcome timeframe

average time period was 3 months

Results posted on

2014-03-17

Participant Flow

The trial was announced by press releases in German leading to self-admittance to the Heidelberg Out-patient Center for Tinnitus. It was offered to patients by ENT-doctors in own practice nationwide and to patients attending the ENT-clinic of the university hospital Heidelberg. Recruitment took place between March 2006 and February 2013.

complete audiometric and psychological profile (exclusion of 10 patients due to incomplete data)

Participant milestones

Participant milestones
Measure	Music Therapy Neuro-Music-Therapy according to the Heidelberg Model Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning. For more details on the music therapy see Argstatter et al. 2012	Counselling Counselling Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group.
Overall Study STARTED	146	144
Overall Study COMPLETED	145	144
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuro-Music-Therapy for Patients With Chronic Tinnitus - a Controlled Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Music Therapy n=146 Participants Neuro-Music-Therapy according to the Heidelberg Model Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning. For more details on the music therapy see Argstatter et al. 2012	Counselling n=144 Participants Counselling Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group.	Total n=290 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	125 Participants n=5 Participants	119 Participants n=7 Participants	244 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Age, Continuous	52.0 years STANDARD_DEVIATION 11.6 • n=5 Participants	53.2 years STANDARD_DEVIATION 11.9 • n=7 Participants	52.5 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	96 Participants n=7 Participants	200 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	48 Participants n=7 Participants	90 Participants n=5 Participants
Region of Enrollment Germany	146 participants n=5 Participants	144 participants n=7 Participants	290 participants n=5 Participants
TQ-score	33.0 units on a scale STANDARD_DEVIATION 14.8 • n=5 Participants	32.9 units on a scale STANDARD_DEVIATION 13.4 • n=7 Participants	32.9 units on a scale STANDARD_DEVIATION 15.0 • n=5 Participants
Tinnitus Pitch	5805 Hz STANDARD_DEVIATION 2594 • n=5 Participants	5851 Hz STANDARD_DEVIATION 2678 • n=7 Participants	5834 Hz STANDARD_DEVIATION 2622 • n=5 Participants

PRIMARY outcome

Timeframe: average time period was 3 months

Outcome measures

Outcome measures
Measure	Music Therapy n=146 Participants Neuro-Music-Therapy according to the Heidelberg Model Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning. For more details on the music therapy see Argstatter et al. 2012	Counselling n=144 Participants Counselling Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group.
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment	13.6 absolute TF-score change Standard Deviation 7.4	3.7 absolute TF-score change Standard Deviation 6.8

SECONDARY outcome

Timeframe: the average time period was 3 months

Outcome measures

Outcome measures
Measure	Music Therapy n=146 Participants Neuro-Music-Therapy according to the Heidelberg Model Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning. For more details on the music therapy see Argstatter et al. 2012	Counselling n=144 Participants Counselling Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group.
Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)	2342 Hz Standard Deviation 3768	530 Hz Standard Deviation 2036

Adverse Events

Music Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Counselling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heike Argstatter

Deutsches Zentrum für Musiktherapieforschung (Viktor Dulger Institut) DZM e.V. - German Center for Music Therapy Research

Phone: +49-6221-7963960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place