NCT00730834

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 25, 2009

Status Verified

August 1, 2009

Enrollment Period

3.5 years

First QC Date

August 5, 2008

Last Update Submit

August 24, 2009

Conditions

TinnitusHyperacusis

Keywords

tinnitusringing in the earsbuzzingstatichyperacusisloudness discomfortClinicallysignificantdiscomfort

Outcome Measures

Primary Outcomes (1)

  • Pre and post treatment scores on Tinnitus reaction questionnaire

    6, 12, 24, 36 months

Secondary Outcomes (1)

  • Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,

    6, 12, 24, 36 months

Interventions

OasisDEVICE

Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds

Also known as: Neuromonics Oasis Tinnitus Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hearing PTA \> 50 dB, score on HADS of greater than 11 on the anxiety and depression scale,
  • Not willing to follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silverstein Ear Institute

Sarasota, Florida, 34239, United States

Location

Related Links

MeSH Terms

Conditions

TinnitusHyperacusis

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 8, 2008

Study Start

June 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 25, 2009

Record last verified: 2009-08

Locations

US(1)