Stress Management Therapy for Meniere's Disease

Not Applicable

• Conditions: Meniere's Disease; Stress
• Interventions: Behavioral: Lifestyle

• Registration Number: NCT01099046
• Lead Sponsor: Osaka University

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-12-27
• Status Verified: 2010-04
• Study First Submitted QC: 2010-04-03
• Last Update Submitted: 2010-04-03
• Study First Posted: 2010-04-06
• Last Update Posted: 2010-04-06
• Primary Completion: 2015-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
medication only	Lifestyle	medication = anti-diuretics
medication + water intake	Lifestyle	anti-diuretics + water intake (at least 2.0 litters per day)
medication + tympanic tubing	Lifestyle	anti-diuretics + tympanic tubing (under local anesthesia)
medication + regular sleep	Lifestyle	anti-diuretics + regular sleep (regular sleep program under dark everynight)

Primary Outcome Measures

Name	Time	Method
all cause mortality	one year

Trial Locations

Locations (1)

Department of Otolaryngology, Osaka University, School of Medicine; 🇯🇵 Suita-city, Osaka, Japan