| - candidate number | 2517 |
| - NTR Number | NTR932 |
| - ISRCTN | ISRCTN17631678 |
| - Date ISRCTN created | 11-apr-2007 |
| - date ISRCTN requested | 24-mrt-2007 |
| - Date Registered NTR | 12-mrt-2007 |
| - Secondary IDs | N/A |
| - Public Title | Phase Out as a treatment for Tinnitus |
| - Scientific Title | Phase Out as a treatment for chronic untreatable tinnitus: a double blind crossover trial |
| - ACRONYM | N/A |
| - 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. |
| - Healt Condition(s) or Problem(s) studied | Tinnitus, Phase Out |
| - Inclusion criteria | 1. Subjects > 18 years; 2. Unilateral or bilateral tinnitus; 3. Predominant tone tinnitus by history; 4. Tinnitus for minimum of 3 months; |
| - 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 standardized normal hearing on standard frequencies of a tone audiogram (250; 500; 1000; 2000; 4000 en 8000 hertz). |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Crossover |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-mei-2007 |
| - planned closingdate | 1-mei-2009 |
| - Target number of participants | 60 |
| - Interventions | 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 sent them back after filling in. |
| - Primary outcome | The major aim of this study is disappearance (report mark) of the tinnitus lasting many hours (time). |
| - Secondary outcome | Besides the mojor aims, different questionnaires will be used to determine for which kind of tinnitus patients, this treatment is most effective (THI, TRQ, VE, HADS, SF-36, Eysenck, type D personality, SSQ and TCSQ). |
| - Timepoints | |
| - Trial web site | - |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | drs. K.M. Heijneman |
| - CONTACT for SCIENTIFIC QUERIES | drs. K.M. Heijneman |
| - Sponsor/Initiator | University Medical Center Groningen (UMCG), Department of Ear, Nose and Throat medicine |
| - Funding (Source(s) of Monetary or Material Support) | University Medical Center Groningen (UMCG) |
| - Publications | N/A |
| - Brief summary | Approximately 10-15% of the general population complains about tinnitus. In spite of the many investigations over the years, little is known about the pathophysiology and the treatment of tinnitus. The last decade different therapies have been developed. One of the new therapies is called ‘Phase Out’. This therapy is based on the physical mechanism of sound. In physics, sound is a wave and can shift in phase over 360 degrees. The hypothesis is that, shifting phase provides a better residual inhibition. Following the hypothesis there is an increased efficacy in comparison with placebo sound. This means that the intensity of tinnitus is decreased with the Phase Out treatment and effects will be sustained. In this prospective, double blind, randomized placebo controlled crossover trail, Phase Out treatment will be compared to a treatment with placebo sound in 60 subjects. The effects will be measured by daily report marks and tinnitus and general questionnaires after a week of treatment. |
| - Main changes (audit trail) | |
| - RECORD | 12-mrt-2007 - 26-feb-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl