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
Sponsor:
Information provided by:
Neuromonics, Inc.
ClinicalTrials.gov Identifier:
NCT00730834
First received: August 5, 2008
Last updated: August 24, 2009
Last verified: August 2009

August 5, 2008
August 24, 2009
June 2007
December 2010   (final data collection date for primary outcome measure)
Pre and post treatment scores on Tinnitus reaction questionnaire [ Time Frame: 6, 12, 24, 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00730834 on ClinicalTrials.gov Archive Site
Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale, [ Time Frame: 6, 12, 24, 36 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis
Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis

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).

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Tinnitus
  • Hyperacusis
Device: Oasis
Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds
Other Name: Neuromonics Oasis Tinnitus Treatment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
53
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00730834
CALM Study, 20071022
No
Jack Wazen, MD, Silverstein ear institute
Neuromonics, Inc.
Not Provided
Not Provided
Neuromonics, Inc.
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP