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Phase Out in Tinnitus Patients

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00833950
First received: January 30, 2009
Last updated: March 2, 2009
Last verified: December 2008
History of Changes
  Purpose

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 Intervention Phase
Tinnitus
 Device: Phase Out treatment in pure tone tinnitus patients
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Out Treatment for Tinnitus

Resource links provided by NLM:

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

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: 3x/week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Score on Tinnitus Questionnaire [ Time Frame: week 0, week 3, week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2008
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833950

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

No publications provided

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
Study First Received: January 30, 2009
Last Updated: March 2, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on June 18, 2013