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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01099046
Other study ID # yk19700512
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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