Clinical trial: Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift (NCT01444846)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy subjects at the time of enrollment.

          -  Each subject will give informed consent to participate in this study and agrees to the
             treatment protocol.

          -  Each subject will be interviewed regarding hearing and health to reveal any history of
             hearing loss, tinnitus, known ear pathology, use of any potentially ototoxic
             medications (i.e. diuretics, minocycline).

          -  Non-occupational sound exposure (e.g., concerts, firearms, fireworks, power tools)
             will be avoided during the 24-hour period preceding baseline testing and throughout
             the duration of the study.

          -  Subjects will have vital signs (i.e., heart rate, blood pressure, respirations,
             temperature) within normal limits upon medical examination.

          -  Subjects must have normal audiologic assessment at baseline consisting of:

          -  Baseline audiometric evaluation confirms that subjects have symmetric hearing with air
             conduction thresholds no worse than 25 decibels of Hearing Loss (dBHL) at frequencies
             between 0.25 to 8 kilo Hertz (kHz) bilaterally.

          -  No significant threshold asymmetry (i.e. greater than 15 dB) between the ears at any
             tested frequency.

          -  No significant air-bone gaps (i.e. greater than 10 dB)

          -  Type A tympanograms bilaterally, defined as a range of -140 to +40 dekaPascals (daPa)
             based on the 90% range for adults (Margolis and Hunter 2000)

        Exclusion Criteria:

          -  • Subjects with abnormal hearing levels > 25 dBHL at any tested frequency (250, 500,
             1000, 2000, 3000, 4000, 6000 and 8000 Hz) for either ear.

          -  Exposure to any duration of non-occupational high-level sound (e.g., concerts,
             firearms, fireworks, power tools) during the 24 hour period preceding baseline
             audiometric testing as revealed in the subject questionnaire or during the medical
             examination.

          -  Pathology of the external ear discovered upon otoscopic examination.

          -  Pathology of the middle ear revealed by otoscopic examination, abnormal tympanometry,
             or reported history of middle ear problems.

          -  Pathology of the inner ear or auditory nerve as revealed by reported history.

          -  Subject complaints of aural pain, pressure, fullness, or drainage.

          -  Subjects testing positive for pregnancy will be excluded from the study.

          -  Subjects with other medical/health issues that would preclude voluntary participation
             in a drug study may be excluded at the discretion of the Principal Investigator.

          -  Subjects that have previously received any known potentially ototoxic medication. This
             includes, but is not limited to, high dose salicylates (>2 g/day), platinum-based
             chemotherapeutics and aminoglycoside antibiotics, such as streptomycin,
             gentamicin,tobramycin, amikacin, neomycin, and netilmycin.

          -  Subjects that are currently using of any potentially ototoxic medications (i.e.
             diuretics or minocycline).

          -  Subjects that have received any investigational treatment (drug or device) in the six
             months prior to this study.

          -  Subjects exhibiting or self-reporting shortness of breath, wheezing, coughing, or
             hemoptysis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 31 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction