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

NCT06819202 | Not Yet Recruiting

• 1 other identifier: PTEC-A-2025-1(S)-1
• Study Type: observational
• Target: 1,309
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sudden Sensorineural Hearing Loss (SSNHL); Hyperbaric Oxygen Therapy

Outcome Measures

Primary Outcomes (1)

• Hearing recovery rate

  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.

  From onset to 3 months after treatment

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

From January 2022 to September 2024, in Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Otolaryngology Hospital Affiliated to Fudan University, Xinhua Hospital affiliated to Shanghai Jiao Tong University or Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, treating patients with sudden sensorineural deafness.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yuting: lead

Study Sites (1)

Shanghai University of Traditional Chinese Medicine

Shanghai, Putuo, 200333, China

Location

MeSH Terms

Conditions

Hearing Loss, Sudden

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sun Yuting

CONTACT

+89 198 2175 8594; syt_354@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 11, 2025
• Study Start: June 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)