Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of meniere disease.
- Age between 18 and 65 years.
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants receive laser acupuncture or control interventions to treat Meniere Disease.
Weekly visits for 3 months
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here