The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- Ginaton
- Conditions
- Sudden Hearing Loss
- Sponsor
- Beijing Tsinghua Chang Gung Hospital
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- hearing threshold
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Ye Jingying
Director of the dept. of Otolaryngology, Head and Neck Surgery, and Director of the Center of Sleep Medicine
Beijing Tsinghua Chang Gung Hospital
Eligibility Criteria
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.
Arms & Interventions
medication
patients treated by medication only
Intervention: Ginaton
PAP plus medication
patients treated by both PAP and medication
Intervention: non-invasive positive airway pressure
PAP plus medication
patients treated by both PAP and medication
Intervention: Methylprednisolone Hemisuccinate
PAP plus medication
patients treated by both PAP and medication
Intervention: Ginaton
medication
patients treated by medication only
Intervention: Methylprednisolone Hemisuccinate
Outcomes
Primary Outcomes
hearing threshold
Time Frame: 3 months after onset of ISSHL
the recovery of hearing threshold which will be measured by pure tone audiometry