The Effect of Gabapentin on the Sensation and Impact of Tinnitus
Primary Purpose
Tinnitus
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring Chronic, Tinnitus, Acoustic trauma, Psychophysics, Loudness match, gabapentin
Eligibility Criteria
Inclusion Criteria: non-pulsatile tinnitus present > 1 year Tinnitus Handicap Questionnaire score > 30 ability to perform psychophysical matching procedure Exclusion Criteria: evidence of depression renal insufficiency conductive hearing loss
Sites / Locations
Outcomes
Primary Outcome Measures
Psychophysical loudness match of tinnitus to broad band noise and pure tones.
Subjective evaluation of tinnitus impact using Tinnitus Handicap Questionnaire.
The subjective and objective measures were obtained after treatment with placebo and 4 doses of gabapentin.
Secondary Outcome Measures
Quality of Life survey (SF36-QOL)
Full Information
NCT ID
NCT00257270
First Posted
November 18, 2005
Last Updated
November 18, 2005
Sponsor
Tinnitus Research Consortium
1. Study Identification
Unique Protocol Identification Number
NCT00257270
Brief Title
The Effect of Gabapentin on the Sensation and Impact of Tinnitus
Official Title
The Effect of Gabapentin on the Sensation and Impact of Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tinnitus Research Consortium
4. Oversight
5. Study Description
Brief Summary
This study evaluated the effectiveness of gabapentin in treating tinnitus in two populations: Tinnitus with associated acoustic trauma and tinnitus without associated acoustic trauma. The hypothesis was that gabapentin would decrease both subjective and objective features of tinnitus in the trauma group, but would be less effective in the non-trauma group.'
Detailed Description
Methods. A prospective, placebo-controlled, single-blind study of the effect of gabapentin on tinnitus was employed. Audiograms and personal histories were used to categorize tinnitus etiology as either secondary to acoustic trauma, or not associated with acoustic trauma. Participants were restricted to those with moderate-to-severe tinnitus for at least one year. All participants received gabapentin in a graduated ascending-descending dose series over 20 weeks (peak dose of 2400 mg/day).
Results. There was a significant improvement in tinnitus annoyance for the trauma group (p = 0.05). Other subjective aspects of tinnitus were not significantly affected in either group. Between-subject variability of therapeutic response was considerable. Nevertheless, considering subjective loudness ratings, 4/19 non-trauma participants, and 6/20 trauma participants showed an improvement of 20 percent or better. Considering psychoacoustic loudness estimates, 4/19 non-trauma and 6/20 trauma participants showed a 15 dB (HL) improvement. Evenly dividing each group into high and low responders revealed significant improvement in loudness at 1800 and 2400 mg/day for the trauma high-response subgroup (p = 0.007). No significant improvement was obtained for other subgroups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Chronic, Tinnitus, Acoustic trauma, Psychophysics, Loudness match, gabapentin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gabapentin
Primary Outcome Measure Information:
Title
Psychophysical loudness match of tinnitus to broad band noise and pure tones.
Title
Subjective evaluation of tinnitus impact using Tinnitus Handicap Questionnaire.
Title
The subjective and objective measures were obtained after treatment with placebo and 4 doses of gabapentin.
Secondary Outcome Measure Information:
Title
Quality of Life survey (SF36-QOL)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
non-pulsatile tinnitus present > 1 year
Tinnitus Handicap Questionnaire score > 30
ability to perform psychophysical matching procedure
Exclusion Criteria:
evidence of depression
renal insufficiency
conductive hearing loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Bauer, MD
Organizational Affiliation
Southern Illinois University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Effect of Gabapentin on the Sensation and Impact of Tinnitus
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