Phase out as a treatment for chronic untreatable tinnitus: a double blind crossover trial
| ISRCTN | ISRCTN17631678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17631678 |
| Protocol serial number | N/A |
| Sponsor | University Medical Centre Groningen (UMCG) (The Netherlands) |
| Funder | University Medical Centre Groningen (UMCG) (The Netherlands) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Universitair Medisch Centrum Groningen
Afd. Keel-,Neus-, Oorheelkunde
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 361 8053 |
|---|---|
| k.m.heijneman@kno.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo controlled, crossover, double blinded trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
The major aim of this study is disappearance (report mark) of the tinnitus lasting many hours (time). |
| Key secondary outcome measure(s) |
Besides the major aims, different questionnaires will be used to determine for which kind of tinnitus patients, this treatment is most effective: |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 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
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
