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Safety and efficacy of a new pulse pressure generator in the treatment of Meniere's disease

Safety and efficacy of a new pulse pressure generator in the treatment of Meniere's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035905
Enrollment
Unknown
Registered
2020-08-19
Start date
2020-10-12
Completion date
Unknown
Last updated
2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniere's disease

Interventions

Standard Control:1.2Kpa
88s
Medium Intervention:1.8KPa
Intensive Intervention:1.8KPa, 184s

Sponsors

The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years old, be able to complete the examination; (2) Patients with Meniere's disease in each stage who met the "clinical diagnosis" criteria and whose symptoms were mainly caused by one ear; (3) Vestibular dysfunction was found in the affected ears; (4) MRI of internal auditory canal excluded cerebellopontine angle or other intracranial space occupying lesions; (5) Refractory Meniere's disease with unsatisfactory medical treatment effect; (6) The subjects or their legal representatives can understand the purpose of the study, show their adequate compliance with the research protocol, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of inner ear surgery and trauma; (2) Patients with active and bilateral Meniere's disease; (3) Patients with severe cardiovascular and cerebrovascular diseases or organ failure; (4) Patients with severe cervical and lumbar diseases, fractures and craniocerebral trauma are not allowed to move; (5) Those who can't cooperate to complete vestibular function examination; (6) Long term use of the patients with vestibular function inhibition, including diazepam, yunhaining, etc; (7) Patients with other non otogenic vertigo diseases;

Design outcomes

Primary

MeasureTime frame
vestibular function;auditory function;DHI;

Secondary

MeasureTime frame
Attack frequency;

Countries

China

Contacts

Public ContactShi Haibo

The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University

hbshi@sjtu.edu.cn+86 021-24058706

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026