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Oral Statins and Protection From Hearing Loss

ConditionSudden Sensorineural Hearing Loss
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNorthwestern University

About this trial

A small clinical trial for idiopathic sudden sensorineural hearing loss (ISSNHL). Will the addition of an oral statin to the standard treatment (oral methylprednesolone and the salvage therapy of intratympanic dexamethasone) improve the treatment outcome for patients with ISSNHL? This study will compare the two treatments and quantitatively evaluate hearing and speech discrimination and have the patients subjectively evaluate tinnitus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient older than 18 years and younger than 81 years and

Diagnosed with one sided idiopathic sudden sensorineural hearing loss by physical examination, history, audiology, speech interpretation tests and tinnitus evaluation and

Seen in the clinic within the first 14 days after the onset of symptoms. and

Mean hearing threshold equal to or worse than >30 dB averaged across three consecutive frequencies.

Disqualifiers

Children

Prisoners

Pregnant women

Patients who have experienced similar prior events of SSNHL

Trial design

Design model

Parallel

Treatments tested in this trial

  • Statin

    Drug

    Oral dose to be taken with methylprednisolone

  • methylprednisolone

    Drug

    oral dose, standard of care

  • dexamethasone

    Drug

    Drug for intratympanic administration

  • Placebo

    Drug

    Capsule the same as for statins but without statin

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: StatinExperimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change in Pure Tone Audiometry for Hearing Assessment

Pure tone audiometry to calculate Pure tone averages (PTA) at 500 Hz, 1 kHz, 2 kHZ and 4 kHz. will be measured before and at the end of the study. PTA within 15 dB of the pretreatment PTA of the contralateral cochlea will be considered complete improvement. At the end of the study, PTA improvement will be compared between experimental and placebo groups, with a difference of 15 dB or more considered a change in response. PTA at the end of the study will also be compared between a) males and female groups; b)compared between those presenting for treatment within 1 week of loss of hearing and those presenting between 1 week and 2 weeks; c) PTA will also be determined and compared between different age groups. PTA at the end of the study together with word recognition scores at the end of the study will be used to determine the class of hearing improvement using the Gardner-Robertson Scale.

Time frame
At the initiation and the end of the study (up to 4 months after initial assessment)
2

Change in Speech Discrimination

At the beginning and the end of the study, word recognition improvement will be compared a) between experimental and placebo groups;b) between males and female groups; c) compared between those presenting for treatment within 1 week of loss of hearing and those presenting between 1 week and 2 weeks; d) word recognition scores will also be and compared between different age groups. At the end of the study, Word recognition score (% correct). will be used with the PTA at the end of the study to to calculate the Gardner-Robertson classification of hearing improvement.

Time frame
At the initiation and the end of the study, up to 4 months after initial assessment
3

Change in Tinnitus Score

Tinnitus Handicap Index; A 6 point or better change in the index indicates improvement. AT the end of the study, Tinnitus Index improvement (change) will be compared a) between experimental and placebo groups; b) between males and female groups c); compared between those presenting for treatment within 1 week of loss of hearing and those presenting between 1 week and 2 weeks; and d)

Time frame
AT the initiation and the end of the study, up to 4 months after initial assessment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
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