Effectiveness of Integrative Medical Treatment in Sudden Hearing Loss

NCT07235488 | Recruiting

• 1 other identifier: CMUH113-REC2-096
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Sudden hearing loss is an emergency in otolaryngology that requires diagnosis and treatment as soon as possible. The golden treatment period is two weeks since the onset of the disease. However, modern medicine is still unable to fully understand the causes of the disease and in lack of corresponding effective treatments. Current therapies also have their own limitations and side effects. To find an effective and safe treatment, integrating with modern medicine and providing inpatient and outpatient medical care, is an important issue in clinical care. Traditional Chinese medicine has been clinically utilized for a long time with accumulated empirical experience and evidence for its efficacy. It can be used as an alternative therapeutic option for sudden hearing loss. Being with a long period of clinical experience and evidence-based curative effect, acupuncture could be applied as an adjunctive treatment for the sudden hearing loss. Currently, this patient-centered, pragmatic clinical trial compares the effectiveness of using west medicine、combination of west medicine and traditional Chinese medicine. The aim of this study is to explore acceptable and beneficial strategy to reduce the clinical symptoms, to improve quality of life, and decrease medical expenses.

Conditions

Sudden Hearing Loss

Keywords

sudden hearing loss; acupuncture

Outcome Measures

Primary Outcomes (1)

• Pure-tone audiograms

  Changes from baseline to week 1, week 2, and week 4 of the intervention

  baseline, week 1, week 2, and week 4

Secondary Outcomes (5)

• Tinnitus Handicap Inventory

  baseline, week 1, week 2, and week 4

• Dizziness Handicap Inventory

  baseline, week 1, week 2, and week 4

• Blood examination

  baseline

• Laboratory examination

  baseline

• Adverse events

  baseline, week 1, week 2, and week 4

Study Arms (2)

Steroid therapy combined with acupuncture

EXPERIMENTAL

Western Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed. Traditional Chinese Medicine Treatment: Acupuncture was performed once daily for 30 minutes at acupoints around the ear and upper limb on the same side as the affected ear. Six treatment sessions were performed in the first and second weeks, and two sessions were performed in the third and fourth weeks.

Device: Acupuncture

Steroid therapy

ACTIVE COMPARATOR

Western Medicine Treatment: During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.

Drug: steroid therapy

Interventions

Acupuncture DEVICE

Treatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care. Western Medicine Treatment : During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed. Traditional Chinese Medicine Treatment : Acupuncture was performed on peri-auricular and ipsilateral upper limb points, including Ermen (TE21), Tinggong (SI19), Tinghui (GB2), Shuaigu (GB8), Yifeng (TE17), Waiguan (TE5), and Zhongzhu (TE3). The treatment was administered once daily for 30 minutes. During the first and second weeks, a total of six sessions were carried out, followed by two sessions per week in the third and fourth weeks.

Steroid therapy combined with acupuncture

steroid therapy DRUG

Treatment lasted four weeks, starting from the date of admission, and included both inpatient and outpatient care. Western Medicine Treatment : During hospitalization, intravenous steroids were administered. After discharge, oral steroids were administered. For patients who did not respond well to treatment, intratympanic steroid injections were performed.

Steroid therapy

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years, both male and female.
• Meeting the diagnostic criteria for sudden sensorineural hearing loss (SSNHL), defined as hearing loss of \>30 dB affecting at least three consecutive frequencies within 3 days.
• Newly onset of hearing loss within 2 week.
• Fully understanding the purpose and procedures of the study and providing signed informed consent.

You may not qualify if:

• Central nervous system lesions such as vestibular schwannoma or traumatic brain injury.
• Middle ear or retrocochlear pathology.
• History of otologic surgery.
• Hemorrhagic disorders or coagulation abnormalities.
• Inability to cooperate with examinations due to dementia or psychiatric illness.
• Previous treatment for SSNHL on the same affected side within the past 6 months.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

Acupuncture Therapy

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Ming-Cheng Huang, M.D., Ph.D.

CONTACT

+886-4-22052121 Ext. 14561; mchuang1128@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 19, 2025
• Study Start: July 8, 2024
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)