RecruitingPhase 4NCT04192656

The Effect of PAP on ISSHL Comorbided With OSA

The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study


Sponsor

Beijing Tsinghua Chang Gung Hospital

Enrollment

102 participants

Start Date

Nov 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria6

  • sudden hearing loss with certain causes,
  • with severe comorbid diseases,
  • pregnant or breast-feeding women,
  • AHI \<= 15/h,
  • hearing threshold recovered \> 50% when included,
  • previously regularly treated with PAP.

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Interventions

DEVICEnon-invasive positive airway pressure

non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea

DRUGMethylprednisolone Hemisuccinate

Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss

DRUGGinaton

ginnaton is ginkgo biloba extract


Locations(1)

Beijing Tsinhgua Changgung Hospital

Beijing, Beijing Municipality, China

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NCT04192656


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