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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Neuromonics, Inc..
Recruitment status was  Active, not recruiting
Information provided by:
Neuromonics, Inc. Identifier:
First received: August 5, 2008
Last updated: August 24, 2009
Last verified: August 2009
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
Device: Oasis
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale, [ Time Frame: 6, 12, 24, 36 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00730834

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 Identifier: NCT00730834     History of Changes
Other Study ID Numbers: CALM Study  20071022 
Study First Received: August 5, 2008
Last Updated: August 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Neuromonics, Inc.:
ringing in the ears
loudness discomfort

Additional relevant MeSH terms:
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms processed this record on May 24, 2016