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Stress Management Therapy for Meniere's Disease

Reduction of Plasma Vasopressin Level in Patients With Meniere's Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01099046
Acronym
SMT
Enrollment
200
Registered
2010-04-06
Start date
2009-01-31
Completion date
2020-01-31
Last updated
2010-04-06

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

Conditions

Meniere's Disease, Stress

Keywords

Meniere's disease, stress management, vasopressin, V2 receptor, water intake, tympanic tubing, regular sleep under dark

Brief summary

Attacks in Meniere's disease, characterized by vertigo and hearing loss, are well known to occur repeatedly under stressed environment. Hitherto, its pathology was revealed to be inner ear hydrops through human temporal bone studies in 1938. For the pathogenesis of inner ear hydrops resulting in Meniere's attacks, plasma vasopressin elevation due to stress and V2 receptor overexpression in the inner ear could be essential as a basis of this disease. In the present study, we'd like to find the effective and feasible way to reduce plasma vasopressin level in patients with Meniere's disease.

Detailed description

BACKGROUND: For the pathogenesis of inner ear hydrops resulting in Meniere's attacks, plasma vasopressin elevation due to stress and V2 receptor overexpression in the inner ear could be essential as a basis of this disease. In the present study, we'd like to find the effective and feasible way to reduce plasma vasopressin level in patients with Meniere's disease. METHODS: We estimate to enroll 200 Meniere's patients to four study groups in a randomized controlled trial at Osaka University Hospital during this study period 2010-2015. Patients are diagnosed as Meniere's patients according to the 1995 AAO-HNS criteria. Group-I consists of 50 patients who receive just traditional oral intake medication including anti-diuretics. Group-II consists of 50 patients who receive both medication and water intake (at least 2.0 litters per day). Group-III consists of 50 patients who receive both medication and tympanic tubing (under local anesthesia). Group-IV consists of 50 patients who receive both medication and sleep well (regular sleep program under dark everynight). Additional factors to medication in each group are supposed to have influence on hypothalamus. We follow up all these patients at least 12 months and evaluate stress, psychological and dizziness conditions using a couple of questionnaires. We also examine changes in plasma vasopressin level of patients in each group. ESTIMATED RESULTS: Through this study, we can understand the most effective and feasible way to reduce plasma vasopressin level in patients with Meniere's disease. Much more Meniere's patients may be rescued without invasive surgery.

Interventions

BEHAVIORALLifestyle

water intake, tympanic tubing, regular sleep

Sponsors

Osaka University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed as Meniere's patients according to the 1995 AAO-HNS criteria are included into this study.

Exclusion criteria

* Patients refused our prepared four kinds of treatments are excluded from this study.

Design outcomes

Primary

MeasureTime frame
all cause mortalityone year

Countries

Japan

Contacts

Primary ContactTadashi Kitahara, M.D.,Ph.D.
tkitahara@ent.med.osaka-u.ac.jp+81-6-6879-3951
Backup ContactArata Horii, M.D.,Ph.D.
ahorii@ent.med.osaka-u.ac.jp+81-6-6879-3954

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026