The Effect of PAP on ISSHL Comorbided With OSA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Sudden Hearing Loss Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PAP plus medication

patients treated by both PAP and medication

Group Type EXPERIMENTAL

non-invasive positive airway pressure

Intervention Type DEVICE

non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea

Methylprednisolone Hemisuccinate

Intervention Type DRUG

Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss

Ginaton

Intervention Type DRUG

ginnaton is ginkgo biloba extract

medication

patients treated by medication only

Group Type ACTIVE_COMPARATOR

Methylprednisolone Hemisuccinate

Intervention Type DRUG

Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss

Ginaton

Intervention Type DRUG

ginnaton is ginkgo biloba extract

Interventions

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non-invasive positive airway pressure

non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea

Intervention Type DEVICE

Methylprednisolone Hemisuccinate

Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss

Intervention Type DRUG

Ginaton

ginnaton is ginkgo biloba extract

Intervention Type DRUG

Other Intervention Names

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Methylprednisolone, MP Ginkgo biloba extract,GBE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ye Jingying

Director of the dept. of Otolaryngology, Head and Neck Surgery, and Director of the Center of Sleep Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR