Sudden Sensorineural Hearing LossPhase 3SERORLNCT07113158
Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss
A Phase 3 study testing Aspirin + Acid folic in people with Sudden Sensorineural Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The annual incidence of sudden sensorineural hearing loss (SSNHL) is 5 to 20 per 100 000 persons. The pathophysiology of SSNHL and acute vestibulo-cochlear syndromes (VCS) is unknown in more than 70% of cases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sudden Sensorineural Hearing Loss
- What is being tested?
- Aspirin + Acid folic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 1 Nov 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral SSNHL defined as a sudden hearing loss of 30dB or greater at least three contiguous audiometric frequencies (between 125hz and 8000Hz) occurring within a 72 hr period and for less than 15 days.
- Individuals affiliated to a social security regimen
- Individuals able to participate and to follow up during the study period
Who cannot join
- Contra-indications to Aspirin, contra-indications to oral corticosteroid therapy, contra-indications to dexamethasone, allergy to vitamin B9
- Evident cause of acute SSNHL including tumor of the ponto-cerebellous angle, infectious labyrinthitis, mechanical and acoustic trauma, malformation of the inner ear, neurological disorder.
- Patient already including in another clinical trial
- Person under legal protection (under guardianship or curatorship)
- Patients taking serotonin reuptake inhibitors
- Patients already taking aspirin or other anticoagulant or antiplatelet agent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Lariboisière Hospital
Paris, Île-de-France Region, 75010
Charlotte HAUTEFORT, Dr, 0149958062, charlotte.hautefort@aphp.fr
About this study
The annual incidence of sudden sensorineural hearing loss (SSNHL) is 5 to 20 per 100 000 persons. The pathophysiology of SSNHL and acute vestibulo-cochlear syndromes (VCS) is unknown in more than 70% of cases.
Hypothesis : an inner ear microvascular disease represents the key element in the pathogenesis of SSNHL and acute VCS.
Plasma serotonin has among other tissular effect a vasospastic on microcirculation such as the inner ear microvascularisation. Increased plasma homocysteine has a deleterious effect on vascular endothelium. Inner ear microvascularisation sensitized by an increased homocysteine level and the vascular wall would vasoconstrict under serotonin stimulation inducing ischemia of the vestibular and/or cochlear organs.
Read the detailed description
Sudden sensorineural hearing loss (SSNHL) is defined as sensorineural hearing loss of 30dB or greater over at least three contiguous audiometric frequencies occurring over 72 hr 9,10. SSNHL is a relatively common disorder in otologic and audiologic practices (1.5-1.7 per 100 new patients presenting in ENT practice. Most patients with sudden SSNHL have no identifiable cause for hearing loss and are classified as "idiopathic". Despite extensive research, the etiology and therapeutic management of SSNHL and acute VCS remain elusive. Regardless of the etiology, complete or partial recovery of hearing thresholds following SSNHL may not occur. Factors influencing hearing recovery include the age at onset of hearing loss, severity and frequencies affected, the presence of vertigo, and the delay of treatment. The incidence of SSNHL is 5-20 per 100, 000. The true incidence of SSNHL may be higher than these estimates because affected individuals who recover spontaneously do not present for medical care. Although individuals of all ages can be affected, the peak incidence is between the fifth and sixth decade of life. Men and women are equally affected. Nearly all cases of SSNHL are unilateral; less than 2% of patients have bilateral involvement and typically bilateral involvement is sequential. Accompanying symptoms include tinnitus (41% to 90%) and dizziness (29% to 56%) New vestibular function assessment now allows us to specify the vestibular damage associated with SSNHL. Until now, the association with dizziness was a poor prognostic factor for hearing. In a recent study in 2023, more than 60% of patients treated for SSNHL had associated vestibular damage even if they did not complain of vestibular symptoms. 20. Vestibular involvement has often been under-diagnosed and could be a way of targeting more precisely the pathophysiological mechanisms behind SSNHL. Vestibular and cochlear damage can be secondary to a pressure disorder of the endolymphatic system (endolymphatic atelectasis or endolymphatic hydrops) or to microvascular damage of cochlear and/or vestibular arteries (e.g. cochlear artery syndrome), but also to inflammatory damage of the labyrinth. 3D-Flair Endolymph magnetic resonance imaging highlighted the different mechanisms involved in deafness: endolymphatic hydrops or atelectasis, microvascular or inflammatory involvement the presence or absence of a rupture of the blood-labyrinth barrier. For all these disorders, increase serum homocysteine and plasma serotonin levels would be a predisposing factor, weakening the microvascularisation inner ear's vascular endothelium.
- Conditions
- Sudden Sensorineural Hearing Loss
- Being tested
- Aspirin + Acid folic, Placebo Aspirin + Placebo Acid folic
- Keywords
- SSNHL, sudden sensorineural hearing loss, sudden hearing loss, aspirin, acid folic
- 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.
Aspirin + Acid folicDrug
Aspirin 100 mg/day and Acid Folic 5 mg/day + gold standard treatment
Placebo Aspirin + Placebo Acid folicDrug
The Placebo Aspirin 100 mg/j + Placebo folic acid 5 mg/j + reference treatment
| Study group | Role | What they receive |
|---|---|---|
| Investigational medicinal products | Experimental | Aspirin 100 mg/day and Acid Folic 5 mg/day + gold standard treatment (oral corticosteroid therapy 1 mg/kg +/- 3 trans-tympanic injections of dexamethasone)
* Corticosteroid therapy 1mg/kg/day for 7 days
* 3 trans-tympanic injections of corticosteroids if hearing loss persists at D15 Duration of treatment: 3 months Receives: Drug: Aspirin + Acid folic |
| Comparator treatment | Placebo comparator | The Placebo Aspirin 100 mg/j + Placebo folic acid 5 mg/j + reference treatment (oral corticosteroid therapy 1mg/kg +/- 3 trans-tympanic injections of dexamethasone)
* Corticosteroid therapy 1mg/kg/day for 7 days
* 3 trans-tympanic injections of corticosteroids if hearing loss persists at D15 Duration of treatment: 3 months Receives: Drug: Placebo Aspirin + Placebo Acid folic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at D15 as defined by the AAO-HNS
Complete recovery with return to less than 10 dB HL of the unaffected ear, no recovery : anything below 10 dB. Partial recovery is between the two extremes.
Measured: At Day 15
Secondary outcomes (4)
Maximal speech intelligibility (word recognition) score at D15, M3 and M6
Measured: At day 15, 3 month, 6 month
Mean of pure tones defined as the mean PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at M3 and M6 as defined by the AAO-HNS
Complete recovery with return to less than 10 dB HL of the unaffected ear, no recovery : anything below 10 dB. Partial recovery is between the two extremes.
Measured: At month 3, month 6
Quality of life will be evaluated with THI and DHI questionnaire at D15, M3 and M6
Measured: At day 15, month 3, month 6
Vestibular function assessed at D15, M3 and M6 with: • presence or absence of a spontaneous and positional nystagmus • mean gains of the vestibulo-ocular reflex measured by the vHIT
Measured: At day 15, month 3, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Nov 2029 (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 Assistance Publique - Hôpitaux de ParisThe 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
- This is a national phase III, clinical study, multicenter, comparative, randomized on 2 parallel groups, with one group control, of superiority, double blind for the patients, the investigators and the study site staff. Participants distributed between groups at a ratio of (1: 1).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113158
- Sponsor's protocol ID
- APHP230836
- Other IDs
- 2024-513710-35
- Acronym
- SERORL
- Status last verified
- Jan 2026
- First submitted
- 28 Oct 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT07113158
- Acronym / sponsor ID
- SERORL / APHP230836
- Conditions
- Sudden Sensorineural Hearing Loss
- Keywords
- SSNHL, sudden sensorineural hearing loss, sudden hearing loss, aspirin, acid folic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 8 Aug 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.
The annual incidence of sudden sensorineural hearing loss (SSNHL) is 5 to 20 per 100 000 persons. The pathophysiology of SSNHL and acute vestibulo-cochlear syndromes (VCS) is unknown in more than 70% of cases.
Hypothesis : an inner ear microvascular disease represents the key element in the pathogenesis of SSNHL and acute VCS.
Plasma serotonin has among other tissular effect a vasospastic on microcirculation such as the inner ear microvascularisation. Increased plasma homocysteine has a deleterious effect on vascular endothelium. Inner ear microvascularisation sensitized by an increased homocysteine level and the vascular wall would vasoconstrict under serotonin stimulation inducing ischemia of the vestibular and/or cochlear organs.
Detailed description
Sudden sensorineural hearing loss (SSNHL) is defined as sensorineural hearing loss of 30dB or greater over at least three contiguous audiometric frequencies occurring over 72 hr 9,10. SSNHL is a relatively common disorder in otologic and audiologic practices (1.5-1.7 per 100 new patients presenting in ENT practice. Most patients with sudden SSNHL have no identifiable cause for hearing loss and are classified as "idiopathic". Despite extensive research, the etiology and therapeutic management of SSNHL and acute VCS remain elusive. Regardless of the etiology, complete or partial recovery of hearing thresholds following SSNHL may not occur. Factors influencing hearing recovery include the age at onset of hearing loss, severity and frequencies affected, the presence of vertigo, and the delay of treatment. The incidence of SSNHL is 5-20 per 100, 000. The true incidence of SSNHL may be higher than these estimates because affected individuals who recover spontaneously do not present for medical care. Although individuals of all ages can be affected, the peak incidence is between the fifth and sixth decade of life. Men and women are equally affected. Nearly all cases of SSNHL are unilateral; less than 2% of patients have bilateral involvement and typically bilateral involvement is sequential. Accompanying symptoms include tinnitus (41% to 90%) and dizziness (29% to 56%) New vestibular function assessment now allows us to specify the vestibular damage associated with SSNHL. Until now, the association with dizziness was a poor prognostic factor for hearing. In a recent study in 2023, more than 60% of patients treated for SSNHL had associated vestibular damage even if they did not complain of vestibular symptoms. 20. Vestibular involvement has often been under-diagnosed and could be a way of targeting more precisely the pathophysiological mechanisms behind SSNHL. Vestibular and cochlear damage can be secondary to a pressure disorder of the endolymphatic system (endolymphatic atelectasis or endolymphatic hydrops) or to microvascular damage of cochlear and/or vestibular arteries (e.g. cochlear artery syndrome), but also to inflammatory damage of the labyrinth. 3D-Flair Endolymph magnetic resonance imaging highlighted the different mechanisms involved in deafness: endolymphatic hydrops or atelectasis, microvascular or inflammatory involvement the presence or absence of a rupture of the blood-labyrinth barrier. For all these disorders, increase serum homocysteine and plasma serotonin levels would be a predisposing factor, weakening the microvascularisation inner ear's vascular endothelium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a national phase III, clinical study, multicenter, comparative, randomized on 2 parallel groups, with one group control, of superiority, double blind for the patients, the investigators and the study site staff. Participants distributed between groups at a ratio of (1: 1).
| Arm | Type | Receives |
|---|---|---|
| Investigational medicinal products | Experimental | Drug: Aspirin + Acid folicAspirin 100 mg/day and Acid Folic 5 mg/day + gold standard treatment (oral corticosteroid therapy 1 mg/kg +/- 3 trans-tympanic injections of dexamethasone) * Corticosteroid therapy 1mg/kg/day for 7 days * 3 trans-tympanic injections of corticosteroids if hearing loss persists at D15 Duration of treatment: 3 months |
| Comparator treatment | Placebo comparator | Drug: Placebo Aspirin + Placebo Acid folicThe Placebo Aspirin 100 mg/j + Placebo folic acid 5 mg/j + reference treatment (oral corticosteroid therapy 1mg/kg +/- 3 trans-tympanic injections of dexamethasone) * Corticosteroid therapy 1mg/kg/day for 7 days * 3 trans-tympanic injections of corticosteroids if hearing loss persists at D15 Duration of treatment: 3 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral SSNHL defined as a sudden hearing loss of 30dB or greater at least three contiguous audiometric frequencies (between 125hz and 8000Hz) occurring within a 72 hr period and for less than 15 days.
- Individuals affiliated to a social security regimen
- Individuals able to participate and to follow up during the study period
Key exclusion criteria (6 listed)
- Contra-indications to Aspirin, contra-indications to oral corticosteroid therapy, contra-indications to dexamethasone, allergy to vitamin B9
- Evident cause of acute SSNHL including tumor of the ponto-cerebellous angle, infectious labyrinthitis, mechanical and acoustic trauma, malformation of the inner ear, neurological disorder.
- Patient already including in another clinical trial
- Person under legal protection (under guardianship or curatorship)
- Patients taking serotonin reuptake inhibitors
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 |
|---|---|---|
| Aspirin + Acid folicAspirin 100 mg/day and Acid Folic 5 mg/day + gold standard treatment | Drug | Investigational medicinal products |
| Placebo Aspirin + Placebo Acid folicThe Placebo Aspirin 100 mg/j + Placebo folic acid 5 mg/j + reference treatment | Drug | Comparator treatment |
Primary outcome
Mean PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at D15 as defined by the AAO-HNS
Time frame: At Day 15
Complete recovery with return to less than 10 dB HL of the unaffected ear, no recovery : anything below 10 dB. Partial recovery is between the two extremes.
4 secondary outcomes
Maximal speech intelligibility (word recognition) score at D15, M3 and M6
Time frame: At day 15, 3 month, 6 month
Mean of pure tones defined as the mean PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at M3 and M6 as defined by the AAO-HNS
Time frame: At month 3, month 6
Quality of life will be evaluated with THI and DHI questionnaire at D15, M3 and M6
Time frame: At day 15, month 3, month 6
Vestibular function assessed at D15, M3 and M6 with: • presence or absence of a spontaneous and positional nystagmus • mean gains of the vestibulo-ocular reflex measured by the vHIT
Time frame: At day 15, month 3, month 6
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 14 Jan 2026.
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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.
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 Aspirin + Acid folic in people with Sudden Sensorineural Hearing Loss, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 6 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 14 Jan 2026. 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 Charlotte HAUTEFORT, Dr (0149958062, charlotte.hautefort@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean PTA (mean of the change of the hearing thresholds for the 3 most affected contiguous frequencies) at D15 as defined by the AAO-HNS (time frame: At Day 15). 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 14 Jan 2026.