Hydrogen-oxygen Gas Mixture Inhalation in Patients With Sudden Sensorineural Hearing Loss
Primary Purpose
Hearing Loss, Sensorineural
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hydrogen gas therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural
Eligibility Criteria
Inclusion Criteria:
- Meet the criteria of definition of sudden sensorineural hearing loss: hearing loss of 30 dB or more over at least three contiguous frequencies, over a period of 72 hours or less.
- The event attacked within 14 days. -
Exclusion Criteria:
- pregnancy or other vulnerable groups
- specific etiologies of sudden sensorineural hearing loss
- Diabetes mellitus patients -
Sites / Locations
- Kaohsiung Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hydrogen gas inhalation therapy accompanied with standard steroid treatment
Standard steroid treatment
Arm Description
Outcomes
Primary Outcome Measures
hearing recovery
The level of hearing recovery between the two groups
Secondary Outcome Measures
the change of systemic inflammatory status and oxidative stress
Use some indicators of systemic inflammatory status and oxidative stress to measure the changes between the two groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04881435
Brief Title
Hydrogen-oxygen Gas Mixture Inhalation in Patients With Sudden Sensorineural Hearing Loss
Official Title
The Effect of Inhaled Hydrogen on the Prognosis of Idiopathic Sudden Sensorineural Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Idiopathic sudden sensorineural hearing loss (ISSHL) is defined according to American Academy of Otolaryngology as a hearing loss of at least 30 decibel over 3 contiguous test frequencies occurring within a 72h period. It affects 5 to 20 people per 100,000 annually and is characterized by sudden-onset, generally unilateral, sensorineural hearing loss. Its cause is idiopathic in most of the patients; however, vascular disorders have been proposed as the final common pathway. Recent studies have reported that the impaired microvascular perfusion occurring during an ischemic event may be related to oxidative stress which may be synergistically responsible for endothelial damage, especially in terminal microvascular systems.
Hydrogen, which serves as a free radical scavenger and can reduce the strong oxidants, is found as a therapeutic gas in cochlea in recent studies. Both antioxidant and anti-inflammatory effects have been seen with hydrogen administration in animal models. Since cisplatinum toxicity and acoustic trauma both involve oxidative stress to the cochlea, hydrogen may prove useful in these conditions. The efficacy and safety of hydrogen inhalation are also proved in clinical studies.
Given the theories mentioned above, the purpose of our study is to use inhaled hydrogen as an adjuvant therapy for treating idiopathic sudden sensorineural hearing loss. The systemic inflammation status and oxidative stress will be monitored. Both subjective and objective efficacy after treatment will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrogen gas inhalation therapy accompanied with standard steroid treatment
Arm Type
Experimental
Arm Title
Standard steroid treatment
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Hydrogen gas therapy
Intervention Description
Hydrogen gas therapy three times one day for 5 days
Primary Outcome Measure Information:
Title
hearing recovery
Description
The level of hearing recovery between the two groups
Time Frame
1.before treatment 2. after treatment immediately 3.one month later after treatment
Secondary Outcome Measure Information:
Title
the change of systemic inflammatory status and oxidative stress
Description
Use some indicators of systemic inflammatory status and oxidative stress to measure the changes between the two groups
Time Frame
1.before treatment 2. after treatment immediately 3.one month later after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the criteria of definition of sudden sensorineural hearing loss: hearing loss of 30 dB or more over at least three contiguous frequencies, over a period of 72 hours or less.
The event attacked within 14 days. -
Exclusion Criteria:
pregnancy or other vulnerable groups
specific etiologies of sudden sensorineural hearing loss
Diabetes mellitus patients -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Nung Wu, MD
Phone
886975369260
Email
taytay@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Nung Wu, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Nung Wu, MD
Phone
886975369260
Email
taytay@cgmh.org.tw
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan to sharing currently
Citations:
PubMed Identifier
27588164
Citation
Quaranta N, De Ceglie V, D'Elia A. Endothelial Dysfunction in Idiopathic Sudden Sensorineural Hearing Loss: A Review. Audiol Res. 2016 Jul 27;6(1):151. doi: 10.4081/audiores.2016.151. eCollection 2016 Apr 20.
Results Reference
background
PubMed Identifier
28639554
Citation
Gode S, Turhal G, Kaya I, Mavili HI, Kirazli T. Evaluation of Procalcitonin and hs-CRP Levels in Sudden Sensorineural Hearing Loss. J Int Adv Otol. 2018 Apr;14(1):44-47. doi: 10.5152/iao.2017.2780. Epub 2017 Jun 21.
Results Reference
background
PubMed Identifier
21706323
Citation
Capaccio P, Pignataro L, Gaini LM, Sigismund PE, Novembrino C, De Giuseppe R, Uva V, Tripodi A, Bamonti F. Unbalanced oxidative status in idiopathic sudden sensorineural hearing loss. Eur Arch Otorhinolaryngol. 2012 Feb;269(2):449-53. doi: 10.1007/s00405-011-1671-2. Epub 2011 Jun 26.
Results Reference
background
PubMed Identifier
12851547
Citation
Joachims HZ, Segal J, Golz A, Netzer A, Goldenberg D. Antioxidants in treatment of idiopathic sudden hearing loss. Otol Neurotol. 2003 Jul;24(4):572-5. doi: 10.1097/00129492-200307000-00007.
Results Reference
result
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Hydrogen-oxygen Gas Mixture Inhalation in Patients With Sudden Sensorineural Hearing Loss
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