Recruiting PHASE4 Sudden Hearing Loss

New treatment option for Sudden Hearing Loss

Official title The Effect of PAP on ISSHL Comorbided With OSA

ClinicalTrials.gov ID: NCT04192656

What this study is testing

What is Methylprednisolone Hemisuccinate?

Methylprednisolone Hemisuccinate is an investigational medicine, being studied as a potential treatment for sudden hearing loss.

Also referred to as Methylprednisolone, MP.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 70

You may be able to join if

  • 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.

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Beijing, Beijing Municipality, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.