Hearing Loss, SensorineuralEarly Phase 1NCT01186185
Fludrocortisone for Sudden Hearing Loss
A Early Phase 1 study testing Fludrocortisone in people with Hearing Loss, Sensorineural, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Fludrocortisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Mar 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Idiopathic sudden sensorineural hearing loss within 3 months
- Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid
Who cannot join
- 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
Show all 10Show fewer
- Cardiomegaly
- Congestive heart failure
- Electrolyte abnormality
- Concurrent use of barbiturates, phenytoin, fosphenytoin, rifampin, or rifapentine
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss
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.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Fludrocortisone
- Keywords
- sudden, sensorineural, hearing loss, fludrocortisone, mineralocorticoid, steroid
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludrocortisoneDrug
Fludrocortisone 0.2 mg by mouth daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Fludrocortisone | Experimental | Not described Receives: Drug: Fludrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing
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.
Measured: At one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startAug 2012
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: PI moved to new institution, unable to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anh Nguyen-Huynh, MD PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186185
- Sponsor's protocol ID
- IRB00006240
- Status last verified
- Oct 2019
- First submitted
- 19 Aug 2010
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT01186185
- Acronym / sponsor ID
- IRB00006240
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- sudden, sensorineural, hearing loss, fludrocortisone, mineralocorticoid, steroid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI moved to new institution, unable to complete study
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fludrocortisone | Experimental | Drug: Fludrocortisone |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Idiopathic sudden sensorineural hearing loss within 3 months
- Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FludrocortisoneFludrocortisone 0.2 mg by mouth daily for 30 days | Drug | Fludrocortisone |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: PI moved to new institution, unable to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Sensorineural
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
RecruitingPhase 2
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anh Nguyen-Huynh, MD PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fludrocortisone in people with Hearing Loss, Sensorineural, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI moved to new institution, unable to complete study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing (time frame: At one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.