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

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

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Key information

Conditions

Sudden Sensorineural Hearing Loss (SSNHL) Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sudden Hyperbaric Oxygen Therapy Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai University of Traditional Chinese Medicine

Shanghai, Putuo, 200333, China

Location contact

Sun YT Sun, PhD student

CONTACT

[email protected]

19821758594

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperbaric oxygen treatment

Other

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 outcomes

Hearing recovery rate

Time frame: From onset to 3 months after treatment

The rate of hearing recovery in patients with all levels of hearing loss at completion of treatment and at 3 months after termination of treatment was assessed according to the WHO Hearing Loss Rating Criteria 2021 to determine the success of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Sun Yuting

CONTACT

[email protected]

+89 198 2175 8594

Sponsors and collaborators

Lead sponsor

Sun Yuting

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 11, 2025
Registry last updated: May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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