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The Effect of PAP on ISSHL Comorbided With OSA

Sponsor
Beijing Tsinghua Chang Gung Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04192656
Collaborator
(none)
102
Enrollment
1
Location
2
Arms
121
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: non-invasive positive airway pressure
  • Drug: Methylprednisolone Hemisuccinate
  • Drug: Ginaton
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study
Actual Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2029

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. hearing threshold [3 months after onset of ISSHL]

      the recovery of hearing threshold which will be measured by pure tone audiometry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tsinhgua Changgung Hospital Beijing Beijing China 100028

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ye Jingying, Director of the dept. of Otolaryngology, Head and Neck Surgery, and Director of the Center of Sleep Medicine, Beijing Tsinghua Chang Gung Hospital
    ClinicalTrials.gov Identifier:
    NCT04192656
    Other Study ID Numbers:
    • BTCHENT201901
    First Posted:
    Dec 10, 2019
    Last Update Posted:
    Dec 10, 2019
    Last Verified:
    Dec 1, 2019
    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
    Additional relevant MeSH terms:
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive
    Hearing Loss
    Deafness
    Hearing Loss, Sudden
    Methylprednisolone
    Methylprednisolone Acetate
    Methylprednisolone Hemisuccinate
    Prednisolone
    Prednisolone acetate
    Prednisolone hemisuccinate
    Prednisolone phosphate

    Study Results

    No Results Posted as of Dec 10, 2019