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OpenTrials
Completed

NCT Number: NCT01487447

Customized Acoustic Stimulation for the Treatment of Tinnitus

The purpose of this study is to determine the efficacy of a customized sound therapy in reducing tinnitus loudness and increasing the residual inhibition.

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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

Not applicable

Primary location

UC Irvine Medical Center

Orange, California, 92868, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Male or female
  • Tinnitus present for 6 months or more
  • Adequate command of English

Exclusion criteria

  • Active illicit drug use, alcohol dependence
  • Treatable cause of tinnitus
  • History of psychosis
  • Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.

Treatment and study plan

Customized sound

Other

treatment with customized sound therapy

Regular Masker

Other

treatment with white noise

Primary outcomes

  1. Change in score of tinnitus loudness

    Time frame: 0, 1 minute; 1 hour; 1, 2, 4 and 6 months

  2. Change in score of tinnitus annoyance

    Time frame: 0, 1 minute; 1 hour; 1, 2, 4 and 6 months

  3. Change in residual inhibition

    Time frame: 1 minute; 1 hour; 1, 2, 4 and 6 months

  4. Change in score of Tinnitus Handicap Inventory (THI)

    Time frame: 0, 1, 2, 4 and 6 months

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 7, 2011
Registry last updated
Jan 30, 2020

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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