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Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis (CALM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Neuromonics, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by:
Neuromonics, Inc.
ClinicalTrials.gov Identifier:
NCT00730834
First received: August 5, 2008
Last updated: August 24, 2009
Last verified: August 2009
  Purpose
Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. Subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).

Condition Intervention Phase
Tinnitus
Hyperacusis
Device: Oasis
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis

Resource links provided by NLM:


Further study details as provided by Neuromonics, Inc.:

Primary Outcome Measures:
  • Pre and post treatment scores on Tinnitus reaction questionnaire [ Time Frame: 6, 12, 24, 36 months ]

Secondary Outcome Measures:
  • Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale, [ Time Frame: 6, 12, 24, 36 months ]

Enrollment: 53
Study Start Date: June 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Oasis
    Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds
    Other Name: Neuromonics Oasis Tinnitus Treatment
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age,
  • TRQ of at least 17 or above,
  • Able to pay for the treatment,
  • Not using any other treatment for tinnitus,
  • Access to computer and internet,
  • Compliant patient

Exclusion Criteria:

  • Hearing PTA > 50 dB, score on HADS of greater than 11 on the anxiety and depression scale,
  • Not willing to follow the protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730834

Locations
United States, Florida
Silverstein Ear Institute
Sarasota, Florida, United States, 34239
Sponsors and Collaborators
Neuromonics, Inc.
  More Information

Additional Information:
Responsible Party: Jack Wazen, MD, Silverstein ear institute
ClinicalTrials.gov Identifier: NCT00730834     History of Changes
Other Study ID Numbers: CALM Study
20071022
Study First Received: August 5, 2008
Last Updated: August 24, 2009

Keywords provided by Neuromonics, Inc.:
tinnitus
ringing in the ears
buzzing
static
hyperacusis
loudness discomfort
Clinically
significant
discomfort

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

ClinicalTrials.gov processed this record on May 24, 2017