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Stress Management Therapy for Meniere's Disease (SMT)

Primary Purpose

Meniere's Disease, Stress

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Lifestyle
Sponsored by
Osaka University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere's Disease focused on measuring Meniere's disease, stress management, vasopressin, V2 receptor, water intake, tympanic tubing, regular sleep under dark

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Otolaryngology, Osaka University, School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

medication only

medication + water intake

medication + tympanic tubing

medication + regular sleep

Arm Description

medication = anti-diuretics

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

anti-diuretics + tympanic tubing (under local anesthesia)

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

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

Full Information

First Posted
December 27, 2009
Last Updated
April 3, 2010
Sponsor
Osaka University
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1. Study Identification

Unique Protocol Identification Number
NCT01099046
Brief Title
Stress Management Therapy for Meniere's Disease
Acronym
SMT
Official Title
Reduction of Plasma Vasopressin Level in Patients With Meniere's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Osaka University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease, Stress
Keywords
Meniere's disease, stress management, vasopressin, V2 receptor, water intake, tympanic tubing, regular sleep under dark

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
medication only
Arm Type
No Intervention
Arm Description
medication = anti-diuretics
Arm Title
medication + water intake
Arm Type
Active Comparator
Arm Description
anti-diuretics + water intake (at least 2.0 litters per day)
Arm Title
medication + tympanic tubing
Arm Type
Active Comparator
Arm Description
anti-diuretics + tympanic tubing (under local anesthesia)
Arm Title
medication + regular sleep
Arm Type
Active Comparator
Arm Description
anti-diuretics + regular sleep (regular sleep program under dark everynight)
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle
Other Intervention Name(s)
Stress Management Therapy (SMT)
Intervention Description
water intake, tympanic tubing, regular sleep
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tadashi Kitahara, M.D.,Ph.D.
Phone
+81-6-6879-3951
Ext
3951
Email
tkitahara@ent.med.osaka-u.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Arata Horii, M.D.,Ph.D.
Phone
+81-6-6879-3954
Ext
3954
Email
ahorii@ent.med.osaka-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tadashi Kitahara, M.D.,Ph.D.
Organizational Affiliation
Department of Otolaryngology, Osaka University, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Osaka University, School of Medicine
City
Suita-city
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tadashi Kitahara, M.D.,Ph.D.
Phone
+81-6-6879-3951
Ext
3951
Email
tkitahara@ent.med.osaka-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Arata Horii, M.D.,Ph.D.
Phone
+81-6-6879-3954
Ext
3954
Email
ahorii@ent.med.osaka-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Tadashi Kitahara, M.D.,Ph.D.
First Name & Middle Initial & Last Name & Degree
Takao Imai, M.D.,Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
19638944
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.
Results Reference
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PubMed Identifier
19094077
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.
Results Reference
background
PubMed Identifier
18520184
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.
Results Reference
background
PubMed Identifier
18219099
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.
Results Reference
background
PubMed Identifier
15277036
Citation
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. doi: 10.1080/03655230410017661.
Results Reference
background
PubMed Identifier
27362705
Citation
Kitahara T, Okamoto H, Fukushima M, Sakagami M, Ito T, Yamashita A, Ota I, Yamanaka T. A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere's Disease-A Pilot Study. PLoS One. 2016 Jun 30;11(6):e0158309. doi: 10.1371/journal.pone.0158309. eCollection 2016.
Results Reference
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Stress Management Therapy for Meniere's Disease

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