The Clinical Research projects listed below are currently open for enrollment. If you are interested in learning more about any of them contact the Director of the Program, Betty Loy,  betty.loy@utsouthwestern.edu

1. Cochlear Implant Quality of Life of Young Cochlear Implant Users:

• What is Cochlear Implant Quality of Life(CIQoL)research?
  In general, CIQoL research wants to know, "How has having an implant impacted your life with your family, your friends, your schoolwork, and how do you feel about yourself?"
• Why is this important?
  Parents faced with making decisions about cochlear implantation need all the information they can get regarding how the implant will affect their child and family. Answers you provide to us will be passed on to future families in the hope it will help them during a very difficult time. Now, that is important!
• What is involved?
  We have easy to complete questionnaires for all 8 to 11 year olds and 12 to 16 year olds, and parents or guardians. For the younger set, ages 4 to 7, we interview the kids and have questionnaires for the parents.
• How long does this research last?
  We would like for each family to particpate at each age level possible. If we sign you up as a 4-7 year old and interview you, we would then like you to complete a questionnaire when you reach the 8-11 year old level and so on. However, you can stop participation at any time.
• Will you be identified in the research?
  No, everything is recorded in our database with only a study number to identify you. Should you complete more than one age group questionnaire you will be assigned the same study number.
• How do we sign up or find out more?
  Contact Betty Loy by email or call 214-648-7151.
  You may also contact Melissa Sweeney by email or call 214-905-3139.
  

2. The Med-El EAS using the Combi 40 F Cochlear Implant System
The purpose of this study is to demonstrate the safety and effectiveness of the Med-El Electric-Acoustic Stimulator (referred to as EAS), a medical device with an implantalbe electrode array and an external acoustic component designed to provide benefit in speech perception and sound quality to individuals with certain senosorineural hearing impairment.  If you have difficulty hearing  in noisy situations and hearing aids don't seem to help much if at all this study might be for you. The cost of the implant is approximately $28,000 and the study does not reimburse you for the device.

Who is eligible?:  
1. 18 years or older
2. Moderate to severe sensorineural hearing loss in both ears
3. Minimal benefit from hearing aids
4. Normal middle ear anatomy and function
5. No retrocochlear involvement
6. Current user of hearing aids in both ears
7. Must be able to understand general conversation in an oral/aural mode
8. English must be primary language
9. Must be highly motivated and expectations should be realistic.

3. Genetics of Papilloma-Induced Voice Disturbance
Recurrent Respiratory Papillomatosis (RRP) is a chronic disease that affects children and adults. The most common manifestation is warts on the vocal folds, which despite repeated attempts at eradication tend to recur. The warts cause hoarseness and if left unchecked can grow large enough to obstruct the airway and cause shortness of breath and possibly death. In addition, a minority of patients develop distal spread of the papillomas resulting in further narrowing of the airway and obstruction of the lung parenchyma. Rarely, the papilloma may undergo malignant transformation.
The purpose of this study is to discover the genetic elements that confer susceptibility to people who acquire recurrent respiratory papillomatosis. Many people are exposed to the causative virus, human papilloma virus (HPV) 6 and 11, yet only a small fraction of these people develop the disease. Furthermore the disease displays a very wide range of aggressiveness. Determining the genetic basis of susceptibility to HPV will provide insight into the fundamental pathophysiology of RRP and papilloma infections in general. This in turn will facilitate development of rational therapy.
Who is eligible?:
All individuals who were diagnosed with recurrent respiratory papillomatosis before the age of 18 years are eligible for recruitment irrespective to their sex, ethnicity or other current diseases. Their biological parents will also be eligible. If a parent is unwilling or unable to participate then the patient’s biological siblings who share the missing parent will be eligible to participate.
Patients must have had an examination of the larynx by an otolaryngologist and must have had the diagnosis confirmed by histopathologic examination of a biopsy specimen.
If a patient in remission wishes to participate, then blood will be drawn by standard venipuncture but no papilloma specimen will be obtained.

4. A Phase II Pilot Trial of Rituxan for Treatment of Autoimmune Inner Ear Disease
The purpose of this study is to evaluate Rituximab, or as it is also known, Rituxan® as a treatment for autoimmune hearing loss.  Autoimmune hearing loss is characterized by an often sudden hearing loss that may occur in one or both ears.  The loss of hearing is often associated with dizziness and ringing of the ears.  The research is being done because present treatments for this condition are often not effective and it is possible that treatment with Rituximab might provide benefit.
Who is eligible?:
Presence of progressive sensironeural hearing loss greater than or equal to 30 dB in BOTH ears at one or more frequencies (250, 500, 1000, 2000, 3000, 4000, 6000 or 8000) Hz and idiopathic based on clinical evaluation, blood tests, and radiographic imaging.
Documented improvement in hearing by audiogram after one month treatment with High Dose Prednisone.  Improvement is defined by 10 dB improvement in pure tone average (500-3000 dB) or an improvement in word identification score of at least 12% in either ear (both relative to baseline). 
Presence of antibody to HSP70 (otoblot) will be required in approximately 50% of patients enrolled. 
18-75 years of age
Able and willing to give written informed consent and comply with the requirements of the study protocol.
Adequate renal function as indicated by serum creatinine <2 mg/dl.
Adequate liver function, as indicated by AST/ALT, 2 x ULN.
Negative serum pregnancy test (for women of child bearing age)
Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.