The Effect of PAP on ISSHL Comorbided With OSA

Beijing Tsinghua Chang Gung Hospital

Status and phase: Enrolling; Phase 4

Conditions: Sudden Hearing Loss; Obstructive Sleep Apnea

Treatments: Drug: Ginaton; Drug: Methylprednisolone Hemisuccinate; Device: non-invasive positive airway pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT04192656

BTCHENT201901

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

PAP plus medication

Experimental group

Description:

patients treated by both PAP and medication

Treatment:

Device: non-invasive positive airway pressure

Drug: Methylprednisolone Hemisuccinate

Drug: Ginaton

medication

Active Comparator group

Description:

patients treated by medication only

Treatment:

Drug: Methylprednisolone Hemisuccinate

Drug: Ginaton