Hydrogen-oxygen Gas Mixture Inhalation in Patients With Sudden Sensorineural Hearing Loss

Hearing Loss, Sensorineural Clinical Trial

Official title:

The Effect of Inhaled Hydrogen on the Prognosis of Idiopathic Sudden Sensorineural Hearing Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881435
• Other study ID #: 202000554A3
• Status: Recruiting
• Phase: N/A
• 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
• 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 -

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

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