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OpenTrials
Completed

NCT Number: NCT00833950

Phase Out in Tinnitus Patients

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Antwerp university Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phase Out treatment in pure tone tinnitus patients

Device

Phase Out treatment: 30 min 3x/w during 6 weeks

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 3x/week

Secondary outcomes

  1. Score on Tinnitus Questionnaire

    Time frame: week 0, week 3, week 6

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Phase Out Treatment for Tinnitus

Important dates

Study start
2008
Primary completion
2009
First posted
Feb 2, 2009
Registry last updated
Mar 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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