Back to resultsThe Effect of PAP on ISSHL Comorbided With OSA
Primary Purpose
Sudden Hearing Loss, Obstructive Sleep Apnea
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
non-invasive positive airway pressure
Methylprednisolone Hemisuccinate
Ginaton
Sponsored by
About this trial
This is an interventional treatment trial for Sudden Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- aged >= 18 and <= 70,
- diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI > 15/h,
- diagnosed with ISSHL by AAO-HNS 2019 criteria,
- ISSHL onset within 1 week.
Exclusion Criteria:
- sudden hearing loss with certain causes,
- with severe comorbid diseases,
- pregnant or breast-feeding women,
- AHI <= 15/h,
- hearing threshold recovered > 50% when included,
- previously regularly treated with PAP.
Sites / Locations
- Beijing Tsinhgua Changgung HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PAP plus medication
medication
Arm Description
patients treated by both PAP and medication
patients treated by medication only
Outcomes
Primary Outcome Measures
hearing threshold
the recovery of hearing threshold which will be measured by pure tone audiometry
Secondary Outcome Measures
Full Information
NCT ID
NCT04192656
First Posted
December 9, 2019
Last Updated
December 9, 2019
Sponsor
Beijing Tsinghua Chang Gung Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04192656
Brief Title
The Effect of PAP on ISSHL Comorbided With OSA
Official Title
The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tsinghua Chang Gung Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Hearing Loss, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PAP plus medication
Arm Type
Experimental
Arm Description
patients treated by both PAP and medication
Arm Title
medication
Arm Type
Active Comparator
Arm Description
patients treated by medication only
Intervention Type
Device
Intervention Name(s)
non-invasive positive airway pressure
Intervention Description
non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Hemisuccinate
Other Intervention Name(s)
Methylprednisolone, MP
Intervention Description
Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss
Intervention Type
Drug
Intervention Name(s)
Ginaton
Other Intervention Name(s)
Ginkgo biloba extract,GBE
Intervention Description
ginnaton is ginkgo biloba extract
Primary Outcome Measure Information:
Title
hearing threshold
Description
the recovery of hearing threshold which will be measured by pure tone audiometry
Time Frame
3 months after onset of ISSHL
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged >= 18 and <= 70,
diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI > 15/h,
diagnosed with ISSHL by AAO-HNS 2019 criteria,
ISSHL onset within 1 week.
Exclusion Criteria:
sudden hearing loss with certain causes,
with severe comorbid diseases,
pregnant or breast-feeding women,
AHI <= 15/h,
hearing threshold recovered > 50% when included,
previously regularly treated with PAP.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingying Ye, MD
Phone
+86-13701396970
Email
yejingying@163.vip.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haijin Yi, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juanjuan Gao, MD
Organizational Affiliation
Beijing Tsinghua Changung Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
jingying Ye, MD
Organizational Affiliation
Beijing Tsinghua Changung Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Haijin Yi, MD
Organizational Affiliation
Beijing Tsinghua Changung Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mu He, MD
Organizational Affiliation
Beijing Tsinghua Changung Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xin Cao, MA
Organizational Affiliation
Beijing Tsinghua Changung Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xingxing Lu, MA
Organizational Affiliation
Beijing Tsinghua Changung Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sichao Liang, MA
Organizational Affiliation
Beijing Tsinghua Changung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tsinhgua Changgung Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100028
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Cao
Phone
86-15810519277
Email
caoxin19860201@163.com
First Name & Middle Initial & Last Name & Degree
Mu He
Phone
86-15210588954
Email
muhe2009@qq.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
23710145
Citation
Hizli O, Ozcan M, Unal A. Evaluation of comorbidities in patients with OSAS and simple snoring. ScientificWorldJournal. 2013 Apr 18;2013:709292. doi: 10.1155/2013/709292. Print 2013.
Results Reference
background
PubMed Identifier
25388224
Citation
Kayabasi S, Iriz A, Cayonu M, Cengiz B, Acar A, Boynuegri S, Mujdeci B, Eryilmaz A. Vestibular functions were found to be impaired in patients with moderate-to-severe obstructive sleep apnea. Laryngoscope. 2015 May;125(5):1244-8. doi: 10.1002/lary.25021. Epub 2014 Nov 12.
Results Reference
background
PubMed Identifier
21479758
Citation
Casale M, Vesperini E, Potena M, Pappacena M, Bressi F, Baptista PJ, Salvinelli F. Is obstructive sleep apnea syndrome a risk factor for auditory pathway? Sleep Breath. 2012 Jun;16(2):413-7. doi: 10.1007/s11325-011-0517-x. Epub 2011 Apr 9.
Results Reference
background
PubMed Identifier
30134647
Citation
Fu Q, Wang T, Liang Y, Lin Y, Zhao X, Wan J, Fan S. Auditory Deficits in Patients With Mild and Moderate Obstructive Sleep Apnea Syndrome: A Speech Syllable Evoked Auditory Brainstem Response Study. Clin Exp Otorhinolaryngol. 2019 Feb;12(1):58-65. doi: 10.21053/ceo.2018.00017. Epub 2018 Aug 24.
Results Reference
background
PubMed Identifier
22249630
Citation
Sheu JJ, Wu CS, Lin HC. Association between obstructive sleep apnea and sudden sensorineural hearing loss: a population-based case-control study. Arch Otolaryngol Head Neck Surg. 2012 Jan;138(1):55-9. doi: 10.1001/archoto.2011.227.
Results Reference
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The Effect of PAP on ISSHL Comorbided With OSA
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