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

Not Applicable

• Conditions: Hearing Loss, Sensorineural
• Interventions: Device: Hydrogen gas therapy

• Registration Number: NCT04881435
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-17
• Status Verified: 2021-05
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-10
• Last Update Submitted: 2021-05-10
• Study First Posted: 2021-05-11
• Last Update Posted: 2021-05-11
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrogen gas inhalation therapy accompanied with standard steroid treatment	Hydrogen gas therapy	-
Standard steroid treatment	Hydrogen gas therapy	-

Primary Outcome Measures

Name	Time	Method
hearing recovery	1.before treatment 2. after treatment immediately 3.one month later after treatment	The level of hearing recovery between the two groups

Secondary Outcome Measures

Name	Time	Method
the change of systemic inflammatory status and oxidative stress	1.before treatment 2. after treatment immediately 3.one month later after treatment	Use some indicators of systemic inflammatory status and oxidative stress to measure the changes between the two groups

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan