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The Effect of PAP on ISSHL Comorbided With OSA

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04192656
Enrollment
102
Registered
2019-12-10
Start date
2019-11-01
Completion date
2029-12-31
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden Hearing Loss, Obstructive Sleep Apnea

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.

Interventions

DEVICEnon-invasive positive airway pressure

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

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

ginnaton is ginkgo biloba extract

Sponsors

Beijing Tsinghua Chang Gung Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
hearing threshold3 months after onset of ISSHLthe recovery of hearing threshold which will be measured by pure tone audiometry

Countries

China

Contacts

Primary ContactJingying Ye, MD
yejingying@163.vip.com+86-13701396970
Backup ContactHaijin Yi, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026