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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 27, 2007 | ||||
| Last Updated Date | September 12, 2008 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Data from each subject on Modafinil will be compared to his/her data when placed on placebo in an effort to determine the differences in level of arousal with and without drug. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00591019 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Data from each subject on Modafinil will be compared to his/her data when placed on placebo in an effort to determine the differences in level of habituation, and reaction time performance with and without drug. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Use of Modafinil in the Treatment of Tinnitus | ||||
| Official Title ICMJE | Use of Modafinil in the Treatment of Tinnitus | ||||
| Brief Summary | A study on the effects of the FDA approved drug Modafinil upon attention problems associated with tinnitus. This is considered to be a safe drug with few side effects. Each subject will be asked to participate in 3 sessions each lasting approximately 1 hour in which cognitive testing and recordings will be taken. The study involves each subject taking a 2- week supply of Modafinil and a 2- week supply of placebo. We hypothesize inattention related to thalamocortical dysrhythmia found in tinnitus can be reduced by Modafinil thus improving tinnitus symptoms and vigilance. |
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| Detailed Description | Modafinil, a drug primarily used in the treatment for narcolepsy, is also being using in treating attention problems found in Attention Deficit Hyperactive Disorder (ADHD). This study will investigate the efficacy of Modafinil upon attention deficits found in tinnitus patients by assessing pre-attentional and attentional processes in alleviating some of the symptoms associated with tinnitus (e.g., attention deficits, sleep disturbance, mood affect, and/or depression). |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study | ||||
| Condition ICMJE | Tinnitus | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Disease-Specific Concerns
General Medical Concerns
Bevacizumab-Specific Concerns
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| Gender | Both | ||||
| Ages | 20 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 ID ICMJE | NCT00591019 | ||||
| Responsible Party | John L. Dornhoffer, MD, University of Arkansas for Medical Sciences | ||||
| Study ID Numbers ICMJE | # 65171 | ||||
| Study Sponsor ICMJE | University of Arkansas | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Arkansas | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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