Folic acid for Sudden sensorineural hearing loss (SSNHL)

Inclusion criteria

• {"criterion_text":"- Age > 18 and < 80 years\n- 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.\n- Individuals affiliated to a social security regimen\n- Individuals able to participate and to follow up during the study period"}

Exclusion criteria

• {"criterion_text":"Contra-indications to Aspirin,\n- Pregnant or breastfeeding women\n- Contra-indications to oral corticosteroid therapy,\n- Contra-indications to dexamethasone\n- Allergy to vitamin B9\n- 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\n- Patient already including in another clinical trial\n- Person under legal protection (under guardianship or curatorship)\n-Patients taking serotonin reuptake inhibitors\n- Patients already taking aspirin or other anticoagulant or antiplatelet agent"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined by the AAO-HNS: measured as the mean change of hearing thresholds for the 3 most affected contiguous frequencies at Day 15; recovery categories per AAO-HNS (complete recovery: return to <10 dB HL of the unaffected ear; no recovery: anything below 10 dB; partial recovery between these extremes)."}

Secondary endpoints

• {"endpoint_text":"- Maximal speech intelligibility (word recognition) score at D15, M3 and M6.","definition_or_measurement_approach":"Maximal speech intelligibility (word recognition) score measured at Day 15, Month 3 and Month 6."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Mean PTA at Month 3 and Month 6 using AAO-HNS definitions (same measurement/definitions as primary endpoint)."}
• {"endpoint_text":"- Quality of life will be evaluated with THI and DHI questionnaire at D15, M3 and M6.","definition_or_measurement_approach":"Quality of life assessed using THI and DHI questionnaires at Day 15, Month 3 and Month 6."}
• {"endpoint_text":"- Vestibular function assessed at D15, M3 and M6 with: •\tpresence or absence of a spontaneous and positional nystagmus •\t mean gains of the vestibulo-ocular reflex measured by the vHIT","definition_or_measurement_approach":"Vestibular function assessed by presence/absence of spontaneous and positional nystagmus and mean vHIT (vestibulo-ocular reflex) gain at Day 15, Month 3 and Month 6."}

Methods

• Recruitment of patients presenting to ENT emergencies at participating hospital ENT departments in France (patients presenting with unilateral sudden sensorineural hearing loss identified at ENT emergency presentation).

France

Earliest CTIS Part Ii Submission Date

23-09-2025

Latest Decision Or Authorization Date

17-10-2025

Processing Time Days

24

Number Of Sites

4

Number Of Participants

142

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"DGOS et mécène","duties_or_roles":"Source of monetary support","organisation_type":"Funder"}