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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 5, 2008
Last Updated Date	August 24, 2009
Start Date ^ICMJE	June 2007
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 7, 2008)	Pre and post treatment scores on Tinnitus reaction questionnaire [ Time Frame: 6, 12, 24, 36 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00730834 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 7, 2008)	Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale, [ Time Frame: 6, 12, 24, 36 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis
Official Title ^ICMJE	Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis
Brief Summary	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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Tinnitus Hyperacusis
Intervention ^ICMJE	Device: Oasis Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds Other Name: Neuromonics Oasis Tinnitus Treatment
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	53
Estimated Completion Date	December 2010
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00730834
Other Study ID Numbers ^ICMJE	CALM Study, 20071022
Has Data Monitoring Committee	No
Responsible Party	Jack Wazen, MD, Silverstein ear institute
Study Sponsor ^ICMJE	Neuromonics, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Neuromonics, Inc.
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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