The Effect of PAP on ISSHL Comorbided With OSA

Phase 4

Recruiting

• Conditions: Sudden Hearing Loss; Obstructive Sleep Apnea
• Interventions: Device: non-invasive positive airway pressure; Drug: Methylprednisolone Hemisuccinate; Drug: Ginaton

• Registration Number: NCT04192656
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Last Update Submitted: 2019-12-09
• Study First Posted: 2019-12-10
• Last Update Posted: 2019-12-10
• Primary Completion: 2024-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAP plus medication	Ginaton	patients treated by both PAP and medication
PAP plus medication	non-invasive positive airway pressure	patients treated by both PAP and medication
medication	Ginaton	patients treated by medication only
PAP plus medication	Methylprednisolone Hemisuccinate	patients treated by both PAP and medication
medication	Methylprednisolone Hemisuccinate	patients treated by medication only

Primary Outcome Measures

Name	Time	Method
hearing threshold	3 months after onset of ISSHL	the recovery of hearing threshold which will be measured by pure tone audiometry

Trial Locations

Locations (1)

Beijing Tsinhgua Changgung Hospital; 🇨🇳 Beijing, Beijing, China