Suspended

Autoimmunity in Inner Ear Disease

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What is being tested

Corticosteroids

+ Methotrexate
Drug
Who is being recruted

Hearing Loss, Sensorineural

From 18 to 70 Years
+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 1998

See protocol details

Summary

Principal SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)
Last updated: April 24, 2006
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 1998Actual date on which the first participant was enrolled.

The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III, outpatient study. All study participants will be assigned to one of four different groups testing the experimental use of drugs. The study is scheduled to run for 18 months, with a minimum of 11 visits per participant.

Official TitleAutoimmunity in Inner Ear Disease 
Principal SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)
Last updated: April 24, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hearing Loss, Sensorineural
Criteria
4 inclusion criteria required to participate
Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, which has rapidly progressed
Are in good general health
Are sterile or use contraception (if a woman of child-bearing age)
Are able to speak and understand English or Spanish
7 exclusion criteria prevent from participating
Have had any previous reaction to prednisone, or history of psychiatric reaction to corticosteroids
Have used corticosteroids for more than 30 days within the past 90 days. Patients who have been off corticosteroids for at least 30 days may be eligible
Have any significant heart, lung, digestive, blood, or neurologic disorders
Have tuberculosis (TB), brittle or unstable insulin-dependent diabetes mellitus, active malignancy or prior chemotherapy, pancreatitis, active peptic ulcer disease, kidney failure, history of shingles, or known (other) autoimmune disease

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 9 locations
Suspended
House Ear InstituteLos Angeles, United StatesSee the location
Suspended
UCSD Medical CenterSan Diego, United States
Suspended
Univ of Iowa Hosp and ClinicIowa City, United States
Suspended
Johns Hopkins UnivBaltimore, United States
Suspended9 Study Centers