Stress Management Therapy for Meniere's Disease

NCT01099046 | Unknown DMC

• 1 other identifier: yk19700512
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Meniere's Disease; Stress

Keywords

Meniere's disease; stress management; vasopressin; V2 receptor; water intake; tympanic tubing; regular sleep under dark

Outcome Measures

Primary Outcomes (1)

• all cause mortality

  one year

Study Arms (4)

medication only

NO INTERVENTION

medication = anti-diuretics

Behavioral: Lifestyle

medication + water intake

ACTIVE COMPARATOR

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

Behavioral: Lifestyle

medication + tympanic tubing

ACTIVE COMPARATOR

anti-diuretics + tympanic tubing (under local anesthesia)

Behavioral: Lifestyle

medication + regular sleep

ACTIVE COMPARATOR

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

Behavioral: Lifestyle

Interventions

Lifestyle BEHAVIORAL

water intake, tympanic tubing, regular sleep

Also known as: Stress Management Therapy (SMT)

medication + regular sleep; medication + tympanic tubing; medication + water intake; medication only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed as Meniere's patients according to the 1995 AAO-HNS criteria are included into this study.

You may not qualify if:

• Patients refused our prepared four kinds of treatments are excluded from this study.

Sponsors & Collaborators

• Osaka University: lead

Study Sites (1)

Department of Otolaryngology, Osaka University, School of Medicine

Suita, Osaka, 565-0871, Japan

RECRUITING

Related Publications (6)

• 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.

  PMID: 19638944 BACKGROUND

• 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.

  PMID: 19094077 BACKGROUND

• 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.

  PMID: 18520184 BACKGROUND

• 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.

  PMID: 18219099 BACKGROUND

• 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.

  PMID: 15277036 BACKGROUND

• 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.

  PMID: 27362705 DERIVED

MeSH Terms

Conditions

Meniere Disease; Diabetes Insipidus; Diabetes Insipidus, Nephrogenic

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Tadashi Kitahara, M.D.,Ph.D.

  Department of Otolaryngology, Osaka University, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tadashi Kitahara, M.D.,Ph.D.

CONTACT

+81-6-6879-3951; tkitahara@ent.med.osaka-u.ac.jp

Arata Horii, M.D.,Ph.D.

CONTACT

+81-6-6879-3954; ahorii@ent.med.osaka-u.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2009
• First Posted: April 6, 2010
• Study Start: January 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2020
• Last Updated: April 6, 2010

Record last verified: 2010-04

Locations

JP (1)