The Effect of PAP on ISSHL Comorbided With OSA
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Tsinghua Chang Gung Hospital
About this trial
This clinical randomized controlled study is to explore the effect of positive airway pressure(PAP) on patients in Beijing Tsinghua Changgung Hospital diagnosed with both idiopathic sudden sensorineural hearing loss comorbided(ISSHL) and obstructive sleep apnea(OSA) between Dec. 2019 to Dec. 2029.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged >= 18 and <= 70,
diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI > 15/h,
diagnosed with ISSHL by AAO-HNS 2019 criteria,
ISSHL onset within 1 week.
Disqualifiers
sudden hearing loss with certain causes,
with severe comorbid diseases,
pregnant or breast-feeding women,
AHI <= 15/h,
Trial design
Design model
Parallel
Treatments tested in this trial
non-invasive positive airway pressure
Devicenon-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea
Methylprednisolone Hemisuccinate
DrugMethylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss
Ginaton
Drugginnaton is ginkgo biloba extract
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: PAP plus medicationExperimental treatment 3 interventions
Group B: medicationActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
hearing threshold
the recovery of hearing threshold which will be measured by pure tone audiometry
Time frame
3 months after onset of ISSHLSponsors and contacts
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Source ClinicalTrials.gov