Hyperbaric oxygen treatment added to standard care for acute idiopathic sudden sensorineural hearing loss - a multicentre randomized controlled trial

Conditions

Idiopathic sudden sensorineural hearing loss (ISSNHL)

Brief summary

Mean absolute pure tone average (PTA*) at week 14 *PTA=mean hearing-threshold in dB of the 4 frequencies 0,5 kHz, 1kHz, 2kHz and 4kHz

Detailed description

Mean change in PTA (dB) from baseline to week 14, Proportion of patients with improvement of at least 10dB PTA from baseline to week 14, Mean word recognition score (WRS) in percentage-points at week 14 and change from baseline, Categories of hearing recovery according to Siegel's criteria at week 14, Categories of hearing-loss severity and proportion of patients with serviceable hearing according to the AAO-HNS criteria at baseline and week 14, Total score of patient reported communication problems assessed by APHAB-questionnaire at day 1 and week 14, RAND-12 scores at day 1 and week 14, Adverse events (AE) and serious AEs (SAE), Known side-effects of HBOT, Mean APHAB score at week 14

Related papers

No related papers found yet.

Interventions

DRUGOXYGEN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Mean absolute pure tone average (PTA) at week 14 PTA=mean hearing-threshold in dB of the 4 frequencies 0,5 kHz, 1kHz, 2kHz and 4kHz	—

Secondary

Measure	Time frame
Mean change in PTA (dB) from baseline to week 14, Proportion of patients with improvement of at least 10dB PTA from baseline to week 14, Mean word recognition score (WRS) in percentage-points at week 14 and change from baseline, Categories of hearing recovery according to Siegel's criteria at week 14, Categories of hearing-loss severity and proportion of patients with serviceable hearing according to the AAO-HNS criteria at baseline and week 14, Total score of patient reported communication problems assessed by APHAB-questionnaire at day 1 and week 14, RAND-12 scores at day 1 and week 14, Adverse events (AE) and serious AEs (SAE), Known side-effects of HBOT, Mean APHAB score at week 14	—

Measure

Time frame

Mean change in PTA (dB) from baseline to week 14, Proportion of patients with improvement of at least 10dB PTA from baseline to week 14, Mean word recognition score (WRS) in percentage-points at week 14 and change from baseline, Categories of hearing recovery according to Siegel's criteria at week 14, Categories of hearing-loss severity and proportion of patients with serviceable hearing according to the AAO-HNS criteria at baseline and week 14, Total score of patient reported communication problems assessed by APHAB-questionnaire at day 1 and week 14, RAND-12 scores at day 1 and week 14, Adverse events (AE) and serious AEs (SAE), Known side-effects of HBOT, Mean APHAB score at week 14

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Countries

Norway

Outcome results

None listed