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…
ID
Bron
Verkorte titel
Aandoening
tinnitus, Phase Out, oorsuizen
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The major aim of this study is disappearance (report mark) of the tinnitus lasting many hours (time).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
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.
Publiek
K.M. Heijneman
Groningen 9700 RB
The Netherlands
+31503618053
k.m.heijneman@kno.umcg.nl
Wetenschappelijk
K.M. Heijneman
Groningen 9700 RB
The Netherlands
+31503618053
k.m.heijneman@kno.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Subjects > 18 years;
2. Unilateral or bilateral tinnitus;
3. Predominant tone tinnitus by history;
4. Tinnitus for minimum of 3 months;
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL908 |
NTR-old | NTR932 |
Ander register | : N/A |
ISRCTN | ISRCTN17631678 |