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Not yet recruitingNCT06819202Updated May 14, 2025

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

An observational study in Sudden Sensorineural Hearing Loss (SSNHL) and Hyperbaric Oxygen Therapy, sponsored by Sun Yuting. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Sun Yuting · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,309
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Hearing Loss, Sudden with a site in China — 11 open to participants now, 11 under way, 1 of them phase 3. Hearing Loss, Sudden · China.

Started
2025
with 2 others
Observational
3 of 18
2 open now
Primary completion
2025-06
later than 2 of 10 live
Registered
11th of 18
by date
Lead sponsor
1 of 18
Sun Yuting

Among the 18 studies in Hearing Loss, Sudden with a site in China, this one is one of 3 that started in 2025, is one of 3 observational ones, reaches primary completion later than 2 of the 10 other live ones, and was the 11th registered.

By phase

18 studies; the count open now beside each. This study's row is marked.

No phase7 · 3 open
Observationalthis study3 · 2 open
Phase 23 · 3 open
Phase 12 · 0 open
Phase 1/21 · 1 open
Phase 31 · 1 open
Phase 41 · 1 open

By the year they started

First in 2019; this study’s year is marked. 3 started in 2025.

Size and results

Median enrollment 90 across the 15 interventional studies, 90 across the 3 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 18 studies in Hearing Loss, Sudden with a site in China, or all of them as a file.
02

Study 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

03

Conditions studied

  • Sudden Sensorineural Hearing Loss (SSNHL)
  • Hyperbaric Oxygen Therapy

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04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,309 participants (estimated)
Patient registry
No

Interventions

  • OtherHyperbaric 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.

06

What researchers measure

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.

    Time frame: From onset to 3 months after treatment

07

Study locations

1 site
  • Shanghai University of Traditional Chinese Medicine
    Shanghai, Putuo 200333, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2025; primary completion for Jun 2025, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2025
First posted
Feb 11, 2025
StartEst.
Jun 1, 2025
Primary completionEst.
Jun 1, 2025
CompletionEst.
Dec 1, 2025
Last update
May 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06819202
Lead sponsor
Sun Yuting
Responsible party
Sun Yuting (PhD student, Shanghai University of Traditional Chinese Medicine) — Sponsor-investigator
First posted
Feb 11, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
May 14, 2025

Study contacts

Sun Yuting
Contact
syt_354@163.com
+89 198 2175 8594

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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