Tinnitus
Conditions
Keywords
P50, Psychomotor Vigilance Test (PVT), Arousal, Reaction Time
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 vigilance.
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 (e.g., the amplitude of auditory evoked responses and simple reaction time).
Interventions
DRUGModafinil
200 mg/day, morning dose
OTHERPlacebo
Sugar pill once per day in the morning.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* The diagnosis of tinnitus should be established by subject through exam and history performed by study physician in Ear, Nose and Throat (ENT) clinic. * Subjects will be age 20 or older. * Subjects should have tinnitus symptoms severe enough to seek medical attention. * Subjects will have been seen in the Hearing and Balance Center at University of Arkansas for Medical Sciences (UAMS). * Subjects will have had an audiogram. * Signed informed consent. * Women of childbearing potential must have a negative pregnancy test at screening and before being prescribed the study drug. * Peripheral neuropathy. * Hematologic (minimal values) at screening Absolute neutrophil count \> 1,500 mm\^3 Hemoglobin \> 8.0 g/dl Platelet count \> 100,000 mm\^3
Exclusion criteria
Disease-Specific Concerns * Subjects who have locally advanced breast cancer with skin ulceration will be excluded from this study due to the risk of worsening ulcers and healing difficulties * Stage IV breast cancer * Inflammatory breast cancer General Medical Concerns * Subjects with Echo Cardiogram performance status 2, 3, and 4 are not eligible for this study * Allergy to any component of the treatment regimen * Women who are breast feeding * Pregnancy or refusal to use effective contraception while participating in this study * Inability to comply with study and/or follow-up procedures * Subjects with secondary malignancy other than superficial skin cancer (squamous cell carcinoma and basal cell carcinoma of the skin) should be excluded Bevacizumab-Specific Concerns * Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study * Blood pressure of \> 150/100 mmHg. Essential hypertension well controlled with anti hypertensive is not an exclusion criterion * Unstable angina * New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D) * History of myocardial infarction within 6 months * History of stroke within 6 months * Clinically significant peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Presence of central nervous system or brain metastases * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study * Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0 * Pregnant (positive pregnancy test) or lactating * Urine protein: creatinine ratio \>1.0 at screening * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0 * Serious, non-healing wound, ulcer, or bone fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). | 5 weeks | P50 is an auditory evoked response potential sensitive to states of arousal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. | 5 weeks | Simple reaction time to an auditory signal is a measure of attention. |
Countries
United States
Participant flow
Recruitment details
Patients recruited from treatment clinic, seeking treatment for tinnitus.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Subjects were tested at baseline, then entered either the modafinil or placebo condtion and then the remaining condition. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 7 |
Outcome results
Primary
The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset).
P50 is an auditory evoked response potential sensitive to states of arousal.
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Testing. | The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). | 1.25 milli volts | Standard Error 0.15 |
| Modafinil | The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). | 1.47 milli volts | Standard Error 0.28 |
| Placebo | The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). | 1.23 milli volts | Standard Error 0.26 |
Secondary
Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.
Simple reaction time to an auditory signal is a measure of attention.
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Testing. | Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. | 269.80 milli seconds | Standard Error 12.64 |
| Modafinil | Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. | 268.12 milli seconds | Standard Error 14.41 |
| Placebo | Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. | 247.11 milli seconds | Standard Error 8.14 |