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NCT Number: NCT04192656

The Effect of PAP on ISSHL Comorbided With OSA

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.

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Key information

Conditions

Sudden Hearing Loss Apnea Dyssomnias Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sudden Nervous System Diseases Neurologic Manifestations Obstructive Sleep Apnea Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sensation Disorders Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

non-invasive positive airway pressure

Device

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

Methylprednisolone Hemisuccinate

Drug

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

Other names: Methylprednisolone, MP

Ginaton

Drug

ginnaton is ginkgo biloba extract

Other names: Ginkgo biloba extract,GBE

Primary outcomes

  1. hearing threshold

    Time frame: 3 months after onset of ISSHL

    the recovery of hearing threshold which will be measured by pure tone audiometry

Study contacts

Contact information is provided by the study sponsor or research team.

Haijin Yi, MD

CONTACT

Jingying Ye, MD

CONTACT

[email protected]

+86-13701396970

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2029
First posted
Dec 10, 2019
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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