MedTrace Logo

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

NCT04881435 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-05-11

No results posted yet for this study

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.

Conditions

  • Hearing Loss, Sensorineural

Interventions

DEVICE

Hydrogen gas therapy

Hydrogen gas therapy three times one day for 5 days

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Ching-Nung Wu, MD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881435 on ClinicalTrials.gov