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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Hearing Loss, Sensorineural

Treatments: Device: Hydrogen gas therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04881435

202000554A3

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Hydrogen gas inhalation therapy accompanied with standard steroid treatment

Experimental group

Treatment:

Device: Hydrogen gas therapy

Standard steroid treatment

Active Comparator group

Treatment:

Device: Hydrogen gas therapy