Exploring the effects of positive airway pressure on sudden hearing loss and sleep apnea

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

This study is testing if using positive airway pressure therapy can help people with sudden hearing loss and sleep apnea feel better.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Tsinghua Chang Gung Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04192656 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of positive airway pressure (PAP) therapy on patients diagnosed with idiopathic sudden sensorineural hearing loss (ISSHL) who also have obstructive sleep apnea (OSA). Conducted at Beijing Tsinghua Changgung Hospital, the study will enroll participants aged 18 to 70 who meet specific diagnostic criteria for both conditions. The trial will utilize a randomized controlled design to assess the effectiveness of PAP alongside other treatments like Methylprednisolone Hemisuccinate and Ginaton over a period extending from December 2019 to December 2029.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with both ISSHL and OSA with an apnea-hypopnea index greater than 15.

Not a fit: Patients with sudden hearing loss due to identifiable causes or those who have previously received regular PAP treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients suffering from both sudden hearing loss and obstructive sleep apnea.

How similar studies have performed: While there is limited information on similar studies, the approach of using PAP for comorbid conditions like OSA and hearing loss is relatively novel.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tsinhgua Changgung Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Juanjuan Gao, MD — Beijing Tsinghua Changung Hospital
• Study coordinator: Jingying Ye, MD

Conditions Sudden Hearing Loss; Obstructive Sleep Apnea