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Phase Out in Tinnitus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00833950
Recruitment Status : Completed
First Posted : February 2, 2009
Last Update Posted : March 3, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

Phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or partial residual inhibition. This technique is based on the theory by Choy advocating that the induction of a sound wave with a 180 degree phase shift compared to the sound experienced by the patient could result in sound cancelling, likely by negation of the cortical perception of tinnitus.

The aim is to determine the efficacy of the Phase Out treatment in pure tone and narrow band noise tinnitus patients.


Condition or disease Intervention/treatment Phase
Tinnitus Device: Phase Out treatment in pure tone tinnitus patients Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Out Treatment for Tinnitus
Study Start Date : March 2008
Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise Tinnitus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: narrow band noise
Phase out in narrow band noise tinnitus patients
Device: Phase Out treatment in pure tone tinnitus patients
Phase Out treatment: 30 min 3x/w during 6 weeks


Outcome Measures

Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 3x/week ]

Secondary Outcome Measures :
  1. Score on Tinnitus Questionnaire [ Time Frame: week 0, week 3, week 6 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • consult ENT department UZA with tinnitus
  • pure tone tinnitus or narrow band noise tinnitus
  • unilateral tinnitus, or bilateral tinnitus if both ears pure tone or both ears narrow band noise
  • frequency tinnitus > 1kHz
  • cochlear origin tinnitus
  • tinnitus duration 3 months or longer
  • age 18y or more
  • patient being able to cooperate
  • patiënt able to fill in VAS
  • normal MRI pontine angle

Exclusion Criteria:

  • depression: BDI > 21
  • pulsatile tinnitus
  • pregnancy
  • epilepsy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833950


Locations
Belgium
Antwerp university Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
More Information

Responsible Party: Prof Dr P H Van de Heyning, Antwerp University Hospital
ClinicalTrials.gov Identifier: NCT00833950     History of Changes
Other Study ID Numbers: 8/2/12
First Posted: February 2, 2009    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: December 2008

Keywords provided by University Hospital, Antwerp:
Tinnitus
Phase Out

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms