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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04881435
Other study ID # 202000554A3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 17, 2020
Est. completion date April 2022

Study information

Verified date May 2021
Source Chang Gung Memorial Hospital
Contact Ching-Nung Wu, MD
Phone 886975369260
Email taytay@cgmh.org.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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. 2. The event attacked within 14 days. - Exclusion Criteria: 1. pregnancy or other vulnerable groups 2. specific etiologies of sudden sensorineural hearing loss 3. Diabetes mellitus patients -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hydrogen gas therapy
Hydrogen gas therapy three times one day for 5 days

Locations

Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. — View Citation

Göde 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. — View 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary hearing recovery The level of hearing recovery between the two groups 1.before treatment 2. after treatment immediately 3.one month later after treatment
Secondary 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 1.before treatment 2. after treatment immediately 3.one month later after treatment
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