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Not yet recruiting NCT06819202

Effect of Hyperbaric Oxygen Therapy(HBOT) on Patients With Sudden Sensorineural Hearing Loss(SSNHL) and Coagulation Function

— Observational Sudden Sensorineural Hearing Loss (SSNHL) Hyperbaric Oxygen Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperbaric oxygen treatment.
Who it may be relevant to
Registry conditions: Sudden Sensorineural Hearing Loss (SSNHL), Hyperbaric Oxygen Therapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Hyperbaric Oxygen Therapy on Patients With Sudden Sensorineural Hearing Loss and Coagulation Function

Overview

The objective of this observational study was to understand the effect of HBO on patients with SSNHL and its association with coagulation function and prognosis. The main question it aims to answer is whether HBO therapy can improve outcomes and coagulation function in patients with SSNHL. The prognosis of SSNHL patients receiving HBO and SSNHL patients not receiving HBO were compared

Interventions

  • Other Hyperbaric oxygen treatment
    HBO therapy is the process of inhaling 100% pure oxygen in an environment above one atmosphere (pressure range: 2.0-3.0 absolute atmospheres) to treat a disease.

Primary outcome measures

  • Hearing recovery rate [Time frame: From onset to 3 months after treatment]

Eligibility criteria

Inclusion criteria

  • Meet the diagnostic criteria for sudden deafness in the American Academy of Otolaryngology Head and Neck Surgery 2019 Clinical Practice Guidelines for Sudden Deafness;
  • Aged 18-75 years old;
  • Patients with unilateral sudden deafness for the first time, and the onset time is less than 2 weeks.

Exclusion criteria

  • Patients with other ear diseases, such as auditory trauma, barotrauma, retrocochlear disease, bilateral hearing loss, history of chronic otitis media in the same ear, and history of surgery in the same ear;
  • Patients with serious primary diseases such as heart, liver, kidney dysfunction and hematopoietic system diseases;
  • Pregnant and nursing patients;
  • Accompanied by serious mental illness;
  • Patients with incomplete clinical data.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shanghai University of Traditional Chinese Medicine — Shanghai

Identifiers

NCT: NCT06819202 · PTEC-A-2025-1(S)-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗