Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID06544434

Laser Acupuncture for Meniere Disease: A Randomized Controlled Trial

Led by Beijing Tongren Hospital · Updated on 2024-08-09

324

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of laser acupuncture on patients with Meniere disease in this randomized controlled trial sponsored by Beijing Tongren Hospital. The study aims to assess whether laser acupuncture can improve symptoms related to dizziness, tinnitus, hearing loss, and ear fullness. The trial is a Phase 2 study that uses multiple outcome measures to monitor patient progress over time. Participants are divided into three groups: one receiving Multiwave Locked System (MLS) laser acupuncture, another receiving sham acupuncture, and a control group. The MLS laser is a class IV near-infrared device with synchronized laser sources operating at specific wavelengths and power settings. Additionally, some patients receive Betahistine Mesylate tablets taken three times daily at 6 mg per dose. Treatments and assessments occur over a 12-month period with evaluations at baseline, 3, 6, and 12 months. Throughout the study, participants undergo several tests including the Dizziness Handicap Inventory (DHI), Tinnitus Handicap Inventory (THI), Pure Tone Audiometry (PTA), and a visual scale for ear fullness. Other assessments include the Video Head Impulse Test (vHIT) and the Caloric Test to evaluate ear function. These assessments are repeated at multiple time points to track changes. Researchers monitor outcomes to evaluate the therapeutic effects and safety of the treatments over the full duration of the study.

CONDITIONS

Brief Title

Laser Acupuncture for Meniere Disease

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of meniere disease.
  • Age between 18 and 65 years.
Not Eligible

You will not qualify if you...

  • Serious mental illness, social problems, neurological disorders, systemic diseases such as malignant tumors or other serious consumptive diseases.
  • Planning for pregnancy, currently pregnant, or lactating.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 3 months

Participants receive laser acupuncture or control interventions to treat Meniere Disease.

Weekly visits for 3 months

Follow-up

Duration - 9 months

Participants are monitored after treatment to assess long-term effects and outcomes.

Visits at month 6 and month 12

Trial Site Locations

Total: 1 location

1

Beijing TongRen Hospital, Capital Medical University

Beijing, China

Actively Recruiting

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Research Team

D

Dong Wu, Doctor

H

Haihong Lian, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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