The Effect of PAP on ISSHL Comorbided With OSA

December 9, 2019 updated by: Ye Jingying, Beijing Tsinghua Chang Gung Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Haijin Yi, MD

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100028
        • Recruiting
        • Beijing Tsinhgua Changgung Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAP plus medication
patients treated by both PAP and medication
Device: non-invasive positive airway pressure
non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea
Drug: Methylprednisolone Hemisuccinate
Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss
Other Names:
  • Methylprednisolone, MP
Drug: Ginaton
ginnaton is ginkgo biloba extract
Other Names:
  • Ginkgo biloba extract,GBE
Active Comparator: medication
patients treated by medication only
Drug: Methylprednisolone Hemisuccinate
Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss
Other Names:
  • Methylprednisolone, MP
Drug: Ginaton
ginnaton is ginkgo biloba extract
Other Names:
  • Ginkgo biloba extract,GBE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hearing threshold
Time Frame: 3 months after onset of ISSHL
the recovery of hearing threshold which will be measured by pure tone audiometry
3 months after onset of ISSHL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Investigators

  • Principal Investigator: Juanjuan Gao, MD, Beijing Tsinghua Changung Hospital
  • Study Chair: jingying Ye, MD, Beijing Tsinghua Changung Hospital
  • Study Director: Haijin Yi, MD, Beijing Tsinghua Changung Hospital
  • Principal Investigator: Mu He, MD, Beijing Tsinghua Changung Hospital
  • Principal Investigator: Xin Cao, MA, Beijing Tsinghua Changung Hospital
  • Principal Investigator: Xingxing Lu, MA, Beijing Tsinghua Changung Hospital
  • Principal Investigator: Sichao Liang, MA, Beijing Tsinghua Changung Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2029

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTCHENT201901

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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