Condition category
Ear, Nose and Throat
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
29/04/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr K M Heijneman

ORCID ID

Contact details

Universitair Medisch Centrum Groningen
Afd. Keel-,Neus-
Oorheelkunde
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 361 8053
k.m.heijneman@kno.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

This study examines the effect of the Phase Out treatment on chronic, incurable tinnitus in adult subjects in comparison with placebo sound. The expectation of this study is that Phase Out treatment is effective for a longer duration and results in increased residual inhibition than placebo sound.

Ethics approval

Ethics approval received from the Medical Ethical Committee of Groningen on the 26th June 2007 (ref: METc2007/061).

Study design

Randomised, placebo controlled, crossover, double blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Tinnitus

Intervention

A subject will receive Phase Out treatment for thirty minutes three times a week for one week and placebo sound treatment on the same regime during another. One month interval is in between these two sets of treatment. If a treatment is started, the subject fills in a report mark on the “tinnitus loudness” and “tinnitus annoyance” in the tinnitus diary every evening till three weeks after the treatment session. One week after each week of therapy a subject receives the evaluating questionnaires and will send them back after filling in.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The major aim of this study is disappearance (report mark) of the tinnitus lasting many hours (time).

Outcomes will be measured at weeks five and nine.

Secondary outcome measures

Besides the major aims, different questionnaires will be used to determine for which kind of tinnitus patients, this treatment is most effective:
1. Tinnitus Handicap Inventory (THI)
2. Tinnitus Reaction Questionnaire (TRQ)
3. Vital Exhaustion (VE) questionnaire
4. Hospital Anxiety and Depression Scale (HADS)
5. Short Form questionnaire (SF-36)
6. Eysenck Personality Questionnaire
7. Type D Personality Scale
8. Social Support Questionnaire (SSQ)
9. Tinnitus Coping Style Questionnaire (TCSQ)

Outcomes will be measured at weeks five and nine.

Overall trial start date

01/05/2007

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subjects greater than 18 years
2. Unilateral or bilateral tinnitus
3. Predominant tone tinnitus by history
4. Tinnitus for minimum of three months

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

1. Acoustic neurinoma
2. Aortic/outflow tract stenosis
3. Pulsatile tinnitus
4. Pregnancy
5. Inability to correct use of test equipment: unable to cooperate during audiologic examination
6. Known tinnitus etiology, which would demand other treatment
7. Hearing loss greater than 60 decibel compared with standardised normal hearing on standard frequencies of a tone audiogram (250, 500, 1000, 2000, 4000 and 8000 hertz)

Recruitment start date

01/05/2007

Recruitment end date

01/05/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Universitair Medisch Centrum Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (The Netherlands)

Sponsor details

Department of Ear
Nose and Throat Medicine
P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/azg/nl/english/azg/

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Groningen (UMCG) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes