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A Randomized Controlled Study of Hydrogen-Oxygen Gas Mixture Inhalation as an Adjunctive Therapy for Sudden Sensorineural Hearing Loss

A Randomized Controlled Study of Hydrogen-Oxygen Gas Mixture Inhalation as an Adjunctive Therapy for Sudden Sensorineural Hearing Loss

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065705
Enrollment
Unknown
Registered
2022-11-13
Start date
2022-11-15
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden deafness

Interventions

Experimental group:Conventional treatment of sudden deafness+ hydrogen-oxygen gas mixture inhalation treatment
Control group:Conventional treatment of sudden deafness

Sponsors

Yangpu Hospital, Tongji University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, no gender limit; 2. Meet the diagnostic criteria of sudden sensorineural hearing loss(Referring to the Guidelines for the Diagnosis and Treatment of Sudden Deafness (2015)): sudden sensorineural hearing loss with unknown cause within 72 hours, with a decrease in hearing of >= 20 dBHL affecting at least 2 consecutive frequencies; 3. Onset within 2 weeks; 4. Monomaural lesions; 5. Patients have good adherence and sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with middle ear lesions, Meniere's disease, acoustic neuroma and other lesions; 2. History of ototoxic drug use; 3. Critical organ failure or other serious diseases (including myocardial infarction, severe myocardial lesions and refractory heart failure within 12 months prior to enrollment; Severe neurological disease: severe cerebral infarction, intracranial hemorrhage, or increased intracranial pressure within 12 months prior to enrollment; severe liver failure; severe renal failure; with bleeding disorders or bleeding tendencies); 4. Pregnant or lactating patients; 5. Patients who have participated in any other clinical trial of drugs or medical devices within 3 months prior to enrollment; 6. Patients deemed unsuitable for inclusion by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Threshold of Pure Tone Audiometry;

Secondary

MeasureTime frame
Tinnitus Disability Assessment Scale (THI);Visual Analog Scale (VAS) Score of Vertigo;Laboratory Tests;

Countries

China

Contacts

Public ContactLiu Huiru

Yangpu Hospital, Tongji University School of Medicine

liuhuiru2004@126.com+86 15900919851

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026