Sudden Sensorineural Hearing LossPhase 3ECOSUBNCT07067801
Evaluation of Oral Corticosteroid Therapy in Idiopathic Sudden Unilateral Hearing Loss.
A Phase 3 study testing prednisone - oral corticosteroid 1mg/kg/D for 1 week in people with Sudden Sensorineural Hearing Loss, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Context: Idiopathic Sudden Sensorineural Hearing Loss (ISSHL) is a rapid-onset, sensorineural hearing loss of unknown etiology. It is one of the most common ENT emergencies, with spontaneous recovery occurring in 32% to 65% of cases. Treatment remains controversial, and the need for treatment itself is debated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Sensorineural Hearing Loss
- What is being tested?
- prednisone - oral corticosteroid 1mg/kg/D for 1 week
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2025to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women at least 18 years of age
- ISSNH: idiopathic unilateral sensorineural hearing loss occurring in less than 72 hours, with loss of at least 30dB on 3 consecutive frequencies compared with the norm or the contralateral ear, confirmed on audiogram.
- Hearing loss beginning no more than 10 days ago
- Signed informed consent indicating that the subject has understood the purpose and procedures of the study, and agrees to participate in the study and to abide by its requirements and restrictions
- Affiliation with a French social security scheme or beneficiary of such a scheme
Who cannot join
- Otological medical history, illness or treatment affecting hearing
- Pregnancy
- Recurrent ISSNH
- Contraindication to oral corticosteroids or already treated with long-term corticosteroids
- Neurological symptoms other than vertigo or tinnitus
- Persons deprived of liberty by judicial or administrative decision; persons under forced psychiatric care; persons admitted to a health or social establishment for purposes other than research.
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- Adults under legal protection or unable to express their consent
- Subjects who have been excluded from another study or who are on the "national volunteer list".
- Exclusion criteria during the course of the study : discovery of vestibular schwannoma, or other pathology explaining the SUB, on MRI centered on the internal auditory canals and cerebellopontine angles prescribed as part of routine care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Oral Corticosteroid Therapy in Idiopathic Sudden Unilateral Hearing Loss; a Randomized, Double Blind, Futility (Non-superiority) Trial.
Context: Idiopathic Sudden Sensorineural Hearing Loss (ISSHL) is a rapid-onset, sensorineural hearing loss of unknown etiology. It is one of the most common ENT emergencies, with spontaneous recovery occurring in 32% to 65% of cases. Treatment remains controversial, and the need for treatment itself is debated. Oral corticosteroids (OCS) are commonly used as first-line therapy, although they may have short-term side effects. Intratympanic corticosteroid injections (ITCIs) are an option for patients with contraindications to OCS or as a salvage treatment. The most recent Cochrane review includes three placebo-controlled studies on OCS efficacy (totaling 267 patients): two found no superiority of OCS, while one showed improvement in hearing. These studies are inconsistent and present methodological biases. Therefore, a sufficiently powered study is needed to assess OCS efficacy and establish clear treatment recommendations for ISSHL.
Objectives: Primary Objective: To demonstrate the equivalence of OCS as first-line treatment for ISSHL compared to no treatment, in terms of hearing recovery between days 7 and 10. Secondary Objectives: To assess the effect of OCS versus no treatment on tinnitus, and hearing recovery based on initial severity of ISSHL. To evaluate hearing recovery in patients treated with rescue ITCIs. In the absence of equivalence, to investigate the superiority of OCS over no treatment.
Read more
Methods: This multicenter, randomized, controlled equivalence trial will include two arms, each with 215 patients: one receiving OCS and the other a no-treatment control. In the absence of early hearing improvement, ITCIs will be administered regardless of study arm.
Perspective: The goal is to clarify the role of OCS in treating ISSHL and guide the development of updated treatment recommendations.
- Conditions
- Sudden Sensorineural Hearing Loss
- Being tested
- prednisone - oral corticosteroid 1mg/kg/D for 1 week, Placebo
- Keywords
- Sudden Sensorineural Hearing Loss, Corticosteroids, Randomized clinical trial, Placebo
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisone - oral corticosteroid 1mg/kg/D for 1 weekDrug
Study of the Standard of care versus Placebo
PlaceboDrug
Control
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Drug: Placebo |
| Oral Corticosteroid | Experimental | Standard of care Receives: Drug: prednisone - oral corticosteroid 1mg/kg/D for 1 week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early hearing recovery
Hearing recovery defined by (composite criterion) :
- Gain of at least 10dB in pure tone average (PTA) on pure tone audiometry compared with initial PTA in dB,
- or > 10% improvement in intelligibility threshold on speech audiometry, compared with initial intelligibility threshold
Measured: From enrollment to 10 +/- 2 days
Secondary outcomes (4)
Medium-term hearing recovery
Medium-term hearing recovery:
- Gain of at least 10dB in pure tone average (PTA) on pure tone audiometry compared with initial PTA in dB,
- or > 10% improvement in intelligibility threshold on speech audiometry, compared with initial intelligibility threshold
Measured: At 1 month and 3 months after enrollment
Tinnitus handicap
Change in tinnitus-related disability assessed by the Tinnitus Handicap Index (THI) score between inclusion and D10, M1, and M3.
Measured: At 10 days, 1 month and 3 months after enrollment
Medium-term hearing recovery in patients without early recovery and treated with salvage trans-tympanic injections.
Hearing recovery defined by (composite criterion) :
- Gain of at least 10dB in pure tone average (PTA) on pure tone audiometry compared with initial PTA in dB
- or > 10% improvement in intelligibility threshold on speech audiometry, compared with initial intelligibility threshold
Measured: At 1 month and 3 months after enrollment
Subgroup analysis based on initial severity
Subgroup analysis according to initial PTA ≥ 70dB or <70dB
Measured: At 10 days, 1 month and 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study startNov 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled versus placebo, double-blind clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Civil de Strasbourg, CHU de Reims, Centre Hospitalo-Universitaire de Brabois, Vandoeuvre Les Nancy, France, Centre Hospitalier Universitaire Dijon
- Responsible party
- Sponsor
- Investigators
- Laurent TAVERNIER, MD PhD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067801
- Sponsor's protocol ID
- 2025/968
- Acronym
- ECOSUB
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Corticosteroid Therapy in Idiopathic Sudden Unilateral Hearing Loss; a Randomized, Double Blind, Futility (Non-superiority) Trial.
- ClinicalTrials.gov ID
- NCT07067801
- Acronym / sponsor ID
- ECOSUB / 2025/968
- Conditions
- Sudden Sensorineural Hearing Loss
- Keywords
- Sudden Sensorineural Hearing Loss, Corticosteroids, Randomized clinical trial, Placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Hôpital Civil de Strasbourg, CHU de Reims, Centre Hospitalo-Universitaire de Brabois, Vandoeuvre Les Nancy, France, Centre Hospitalier Universitaire Dijon
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jul 2025 (actual)
- 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.
Context: Idiopathic Sudden Sensorineural Hearing Loss (ISSHL) is a rapid-onset, sensorineural hearing loss of unknown etiology. It is one of the most common ENT emergencies, with spontaneous recovery occurring in 32% to 65% of cases. Treatment remains controversial, and the need for treatment itself is debated. Oral corticosteroids (OCS) are commonly used as first-line therapy, although they may have short-term side effects. Intratympanic corticosteroid injections (ITCIs) are an option for patients with contraindications to OCS or as a salvage treatment. The most recent Cochrane review includes three placebo-controlled studies on OCS efficacy (totaling 267 patients): two found no superiority of OCS, while one showed improvement in hearing. These studies are inconsistent and present methodological biases. Therefore, a sufficiently powered study is needed to assess OCS efficacy and establish clear treatment recommendations for ISSHL.
Objectives: Primary Objective: To demonstrate the equivalence of OCS as first-line treatment for ISSHL compared to no treatment, in terms of hearing recovery between days 7 and 10. Secondary Objectives: To assess the effect of OCS versus no treatment on tinnitus, and hearing recovery based on initial severity of ISSHL. To evaluate hearing recovery in patients treated with rescue ITCIs. In the absence of equivalence, to investigate the superiority of OCS over no treatment.
Methods: This multicenter, randomized, controlled equivalence trial will include two arms, each with 215 patients: one receiving OCS and the other a no-treatment control. In the absence of early hearing improvement, ITCIs will be administered regardless of study arm.
Perspective: The goal is to clarify the role of OCS in treating ISSHL and guide the development of updated treatment recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled versus placebo, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Placebo |
| Oral Corticosteroid | Experimental | Drug: prednisone - oral corticosteroid 1mg/kg/D for 1 weekStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women at least 18 years of age
- ISSNH: idiopathic unilateral sensorineural hearing loss occurring in less than 72 hours, with loss of at least 30dB on 3 consecutive frequencies compared with the norm or the contralateral ear, confirmed on audiogram.
- Hearing loss beginning no more than 10 days ago
- Signed informed consent indicating that the subject has understood the purpose and procedures of the study, and agrees to participate in the study and to abide by its requirements and restrictions
- Affiliation with a French social security scheme or beneficiary of such a scheme
Key exclusion criteria (9 listed)
- Otological medical history, illness or treatment affecting hearing
- Pregnancy
- Recurrent ISSNH
- Contraindication to oral corticosteroids or already treated with long-term corticosteroids
- Neurological symptoms other than vertigo or tinnitus
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 |
|---|---|---|
| prednisone - oral corticosteroid 1mg/kg/D for 1 weekStudy of the Standard of care versus Placebo | Drug | Oral Corticosteroid |
| PlaceboControl | Drug | Control |
Primary outcome
Early hearing recovery
Time frame: From enrollment to 10 +/- 2 days
Hearing recovery defined by (composite criterion) : * Gain of at least 10dB in pure tone average (PTA) on pure tone audiometry compared with initial PTA in dB, * or > 10% improvement in intelligibility threshold on speech audiometry, compared with initial intelligibility threshold
4 secondary outcomes
Medium-term hearing recovery
Time frame: At 1 month and 3 months after enrollment
Tinnitus handicap
Time frame: At 10 days, 1 month and 3 months after enrollment
Medium-term hearing recovery in patients without early recovery and treated with salvage trans-tympanic injections.
Time frame: At 1 month and 3 months after enrollment
Subgroup analysis based on initial severity
Time frame: At 10 days, 1 month and 3 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Yes
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Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
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Autologous Circulating Extracellular Vesicles for Total-Type Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss (SSNHL)
Not yet recruitingPhase 2
Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
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RecruitingPhase 4
Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss
Not yet recruiting
CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
Sudden Sensorineural Hearing Loss (SSNHL), Prediabetes / Type 2 Diabetes
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.
Laurent TAVERNIER, MD PhD principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prednisone - oral corticosteroid 1mg/kg/D for 1 week in people with Sudden Sensorineural Hearing Loss, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 24 Jul 2025. 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 France. 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. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joackim MAHDJOUB, MD MSc (+33381218988, jmahdjoub@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early hearing recovery (time frame: From enrollment to 10 +/- 2 days). 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 24 Jul 2025.