RECRUITINGPhase 4INTERVENTIONAL
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
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. aged \>= 18 and \<= 70,
2. diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI \> 15/h,
3. diagnosed with ISSHL by AAO-HNS 2019 criteria,
4. ISSHL onset within 1 week.
Who Should NOT Join This Trial:
1. sudden hearing loss with certain causes,
2. with severe comorbid diseases,
3. pregnant or breast-feeding women,
4. AHI \<= 15/h,
5. hearing threshold recovered \> 50% when included,
6. previously regularly treated with PAP.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. aged \>= 18 and \<= 70,
2. diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI \> 15/h,
3. diagnosed with ISSHL by AAO-HNS 2019 criteria,
4. ISSHL onset within 1 week.
Exclusion Criteria:
1. sudden hearing loss with certain causes,
2. with severe comorbid diseases,
3. pregnant or breast-feeding women,
4. AHI \<= 15/h,
5. hearing threshold recovered \> 50% when included,
6. previously regularly treated with PAP.
Treatments Being Tested
DEVICE
non-invasive positive airway pressure
non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea
DRUG
Methylprednisolone Hemisuccinate
Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss
DRUG
Ginaton
ginnaton is ginkgo biloba extract
Locations (1)
Beijing Tsinhgua Changgung Hospital
Beijing, Beijing Municipality, China