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Fludrocortisone for Sudden Hearing Loss
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Anh Nguyen-Huynh, Oregon Health and Science University.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Oregon Health and Science University
Information provided by (Responsible Party):
Anh Nguyen-Huynh, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01186185
First received: August 19, 2010
Last updated: April 21, 2015
Last verified: April 2015
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Purpose
The standard of care treatment of sudden hearing loss uses a type of steroid called glucocorticoid. Examples of glucocorticoids are prednisone, methylprednisolone and dexamethasone. Not everybody recovers hearing with glucocorticoid treatment. Fludrocortisone is a different type of steroid called mineralocorticoid. Unlike glucocorticoids, which work by reducing inflammation, mineralocorticoids work by changing salt and fluid balance. In animal studies, fludrocortisone is at least as effective as glucocorticoid in preserving hearing. Fludrocortisone is not approved for the treatment of sudden hearing loss. The purpose of this study is to test whether fludrocortisone can treat sudden hearing loss.
| Condition | Intervention |
|---|---|
| Hearing Loss, Sensorineural | Drug: Fludrocortisone |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss |
Resource links provided by NLM:
Genetics Home Reference related topics:
nonsyndromic hearing loss
MedlinePlus related topics:
Hearing Disorders and Deafness
Drug Information available for:
Fludrocortisone acetate
U.S. FDA Resources
Further study details as provided by Anh Nguyen-Huynh, Oregon Health and Science University:
Primary Outcome Measures:
- Hearing [ Time Frame: At one month ]Hearing outcome will be determine by pure-tone and speech audiometry measured at the completion of a one-month course of treatment and compared with pre-treatment test results.
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Fludrocortisone |
Drug: Fludrocortisone
Fludrocortisone 0.2 mg by mouth daily for 30 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 or older
- Idiopathic sudden sensorineural hearing loss within 3 months
- Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid
Exclusion Criteria:
- Other diagnosis for the sudden hearing loss
- Concurrent systemic use of another steroid
- Hypersensitivity to fludrocortisone
- Systemic fungal infection
- Hypertension requiring two or more medications
- Pitting edema
- Cardiomegaly
- Congestive heart failure
- Electrolyte abnormality
- Concurrent use of barbiturates, phenytoin, fosphenytoin, rifampin, or rifapentine
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186185
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186185
Contacts
| Contact: Anh Nguyen-Huynh, MD PhD | 503-494-8135 | nguyanh@ohsu.edu |
Locations
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Anh Nguyen-Huynh 503-260-9192 nguyanh@ohsu.edu | |
| Principal Investigator: Anh Nguyen-Huynh, MD PhD | |
Sponsors and Collaborators
Oregon Health and Science University
Investigators
| Principal Investigator: | Anh Nguyen-Huynh, MD PhD | Oregon Health and Science University |
More Information
| Responsible Party: | Anh Nguyen-Huynh, Assistant Professor, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT01186185 History of Changes |
| Other Study ID Numbers: |
IRB00006240 |
| Study First Received: | August 19, 2010 |
| Last Updated: | April 21, 2015 |
Keywords provided by Anh Nguyen-Huynh, Oregon Health and Science University:
|
sudden sensorineural hearing loss |
fludrocortisone mineralocorticoid steroid |
Additional relevant MeSH terms:
|
Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Fludrocortisone Mineralocorticoids Anti-Inflammatory Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 22, 2017