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SERORL Effect of aspirin and folic acid for sudden sensorineural hearing loss

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513710-35-00
Acronym
APHP230836
Enrollment
142
Registered
2025-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients presenting to ENT emergencies with a unilateral sudden sensorineural hearing loss (SSNHL). SSNHL is defined according to the American ENT society guidelines criteria as a subset of SSNHL that is sensorineural in nature, occurs within a 72 hour window, and consists of a decrease in hearing of ≥30 decibels affecting at least 3 consecutive frequencies: 1. A history of an idiopathic and unilateral sudden decrease in hearing > 72 hours and <15 days. 2. A unilateral sensorineural hearing loss demonstrable on a pure‐tone audiogram at the time of entry into the trial. 3. No other neurological signs except the eight cranial nerve defect; no other types of hearing loss as conductive forms of hearing impairment. 4. No history of fluctuating sensorineu

Brief summary

- 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.

Detailed description

- Maximal speech intelligibility (word recognition) score at D15, M3 and M6., - 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., - Quality of life will be evaluated with THI and DHI questionnaire at D15, M3 and M6., - 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

Interventions

DRUGPLACEBO D'ACIDE FOLIQUE
DRUGPLACEBO D'ASPIRINE PROTECT
DRUGACIDE FOLIQUE CCD 5 mg
DRUGcomprimé

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
- 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.

Secondary

MeasureTime frame
- Maximal speech intelligibility (word recognition) score at D15, M3 and M6., - 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., - Quality of life will be evaluated with THI and DHI questionnaire at D15, M3 and M6., - 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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026