Stress Management Therapy for Meniere's Disease (SMT)

Osaka University

Status: Unknown

Conditions: Meniere's Disease; Stress

Treatments: Behavioral: Lifestyle

Study type: Interventional

Funder types: Other

Identifiers

NCT01099046

yk19700512

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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200 participants in 4 patient groups

medication only

No Intervention group

Description:

medication = anti-diuretics

Treatment:

Behavioral: Lifestyle

medication + water intake

Active Comparator group

Description:

anti-diuretics + water intake (at least 2.0 litters per day)

Treatment:

Behavioral: Lifestyle

medication + tympanic tubing

Active Comparator group

Description:

anti-diuretics + tympanic tubing (under local anesthesia)

Treatment:

Behavioral: Lifestyle

medication + regular sleep

Active Comparator group

Description:

anti-diuretics + regular sleep (regular sleep program under dark everynight)

Treatment:

Behavioral: Lifestyle