Stress Management Therapy for Meniere's Disease

Stress Clinical Trial

— SMT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01099046
• Other study ID #: yk19700512
• Status: Recruiting
• Phase: N/A
• First received: December 27, 2009
• Last updated: April 3, 2010
• Start date: January 2009
• Est. completion date: January 2020

Study information

• Verified date: April 2010
• Source: Osaka University
• Contact: Tadashi Kitahara, M.D.,Ph.D.
• Phone: +81-6-6879-3951
• Email: tkitahara[@]ent.med.osaka-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2020
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease
• Stress

Intervention

Behavioral:
• Lifestyle
water intake, tympanic tubing, regular sleep

Locations

Country	Name	City	State
Japan	Department of Otolaryngology, Osaka University, School of Medicine	Suita-city	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Osaka University

Country where clinical trial is conducted

Japan, 

References & Publications (5)

Horii A, Kitahara T, Uno A, Kondoh K, Morihana T, Okumura S, Nakagawa A, Mitani K, Masumura C, Kubo T. Vestibular function and vasopressin. Acta Otolaryngol Suppl. 2004 Aug;(553):50-3. — View Citation

Horii A, Uno A, Kitahara T, Mitani K, Masumura C, Kizawa K, Kubo T. Effects of fluvoxamine on anxiety, depression, and subjective handicaps of chronic dizziness patients with or without neuro-otologic diseases. J Vestib Res. 2007;17(1):1-8. — View Citation

Kitahara T, Doi K, Maekawa C, Kizawa K, Horii A, Kubo T, Kiyama H. Meniere's attacks occur in the inner ear with excessive vasopressin type-2 receptors. J Neuroendocrinol. 2008 Dec;20(12):1295-300. doi: 10.1111/j.1365-2826.2008.01792.x. — View Citation

Kitahara T, Kubo T, Okumura S, Kitahara M. Effects of endolymphatic sac drainage with steroids for intractable Meniere's disease: a long-term follow-up and randomized controlled study. Laryngoscope. 2008 May;118(5):854-61. doi: 10.1097/MLG.0b013e3181651c4a. — View Citation

Kitahara T, Maekawa C, Kizawa K, Horii A, Doi K. Plasma vasopressin and V2 receptor in the endolymphatic sac in patients with delayed endolymphatic hydrops. Otol Neurotol. 2009 Sep;30(6):812-9. doi: 10.1097/MAO.0b013e3181b11db5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		one year