Phase Out in Tinnitus Patients - Full Text View

Sponsored by:	University Hospital, Antwerp
Information provided by:	University Hospital, Antwerp
ClinicalTrials.gov Identifier:	NCT00833950

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 IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Phase Out Treatment for Tinnitus

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

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
narrow band noise: Experimental 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
Antwerp university Hospital
Edegem, Antwerp, Belgium, 2650

Sponsors and Collaborators

University Hospital, Antwerp

More Information

No publications provided

Responsible Party:	Antwerp University Hospital ( Prof Dr P H Van de Heyning )
Study ID Numbers:	8/2/12
Study First Received:	January 30, 2009
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00833950 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:

Tinnitus
Phase Out

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases

Neurologic Manifestations
Ear Diseases
Tinnitus

Additional relevant MeSH terms:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases

Nervous System Diseases
Neurologic Manifestations
Ear Diseases
Tinnitus

ClinicalTrials.gov processed this record on August 28, 2009