NCT06544434

Laser Acupuncture for Meniere Disease

Laser Acupuncture for Meniere Disease: A Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Objective: To evaluate the effect of laser acupuncture for the patients Meniere disease. Methods: We enrolled 324 patients at Beijing Tongren Hospital. Patients completed outcome measures at baseline, 3 months, 6 months, and 12 months. Video head impulse test (vHIT), The Caloric Test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry (PTA), and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.

Conditions

• Meniere Disease

Interventions

Type	Name	Description
DEVICE	Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy)	MLS laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz.
DRUG	Betahistine Mesylate tablet	Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg, 3 times a day.

Timeline

• Start date: 2021-05-01
• Primary completion: 2024-09-30
• Completion: 2024-10-20
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: China