Phase out as a treatment for chronic untreatable tinnitus: a double blind crossover trial

ISRCTN	ISRCTN17631678
DOI	https://doi.org/10.1186/ISRCTN17631678
Secondary identifying numbers	N/A

Submission date: 11/04/2007
Registration date: 11/04/2007
Last edited: 29/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr K M Heijneman
Scientific

Universitair Medisch Centrum Groningen
Afd. Keel-,Neus-, Oorheelkunde
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 361 8053
Email	k.m.heijneman@kno.umcg.nl

Study information

Study design	Randomised, placebo controlled, crossover, double blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Ethics approval received from the Medical Ethical Committee of Groningen on the 26th June 2007 (ref: METc2007/061).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2007
Completion date	01/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	60
Key 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
Key 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)
Date of first enrolment	01/05/2007
Date of final enrolment	01/05/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Universitair Medisch Centrum Groningen

Groningen
9700 RB
Netherlands

Sponsor information

University Medical Centre Groningen (UMCG) (The Netherlands)
Hospital/treatment centre

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

Website	http://www.umcg.nl/azg/nl/english/azg/
"ROR"	https://ror.org/03cv38k47

Funders

Funder type

Hospital/treatment centre

University Medical Centre Groningen (UMCG) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan