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

Primary Purpose

Tinnitus, Hyperacusis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oasis
Sponsored by
Neuromonics, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, ringing in the ears, buzzing, static, hyperacusis, loudness discomfort, Clinically, significant, discomfort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Silverstein Ear Institute

Outcomes

Primary Outcome Measures

Pre and post treatment scores on Tinnitus reaction questionnaire

Secondary Outcome Measures

Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,

Full Information

First Posted
August 5, 2008
Last Updated
August 24, 2009
Sponsor
Neuromonics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00730834
Brief Title
Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis
Acronym
CALM
Official Title
Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Neuromonics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Hyperacusis
Keywords
tinnitus, ringing in the ears, buzzing, static, hyperacusis, loudness discomfort, Clinically, significant, discomfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Oasis
Other Intervention Name(s)
Neuromonics Oasis Tinnitus Treatment
Intervention Description
Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds
Primary Outcome Measure Information:
Title
Pre and post treatment scores on Tinnitus reaction questionnaire
Time Frame
6, 12, 24, 36 months
Secondary Outcome Measure Information:
Title
Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,
Time Frame
6, 12, 24, 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Silverstein Ear Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.neuromonics.com
Description
Related Info

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

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