Meniere's DiseaseSMTNCT01099046
Stress Management Therapy for Meniere's Disease
A study testing Lifestyle in people with Meniere's Disease and Stress, run by Osaka University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meniere's Disease, Stress
- What is being tested?
- Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2009to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed as Meniere's patients according to the 1995 AAO-HNS criteria are included into this study.
Who cannot join
- Patients refused our prepared four kinds of treatments are excluded from this study.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Otolaryngology, Osaka University, School of Medicine
Suita, Osaka, 565-0871
Tadashi Kitahara, M.D.,Ph.D., +81-6-6879-3951 ext. 3951, tkitahara@ent.med.osaka-u.ac.jp
Arata Horii, M.D.,Ph.D., +81-6-6879-3954 ext. 3954, ahorii@ent.med.osaka-u.ac.jp
About this study
Official title: Reduction of Plasma Vasopressin Level in Patients With Meniere's Disease
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.
Read the 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.
- Conditions
- Meniere's Disease, Stress
- Being tested
- Lifestyle
- Keywords
- Meniere's disease, stress management, vasopressin, V2 receptor, water intake, tympanic tubing, regular sleep under dark
- Medical subject headings
- Meniere Disease, Diabetes Insipidus, Diabetes Insipidus, Nephrogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestyleBehavioural
Also called Stress Management Therapy (SMT)
water intake, tympanic tubing, regular sleep
| Study group | Role | What they receive |
|---|---|---|
| medication only | No intervention | medication = anti-diuretics Receives: Behavioral: Lifestyle |
| medication + water intake | Active comparator | anti-diuretics + water intake (at least 2.0 litters per day) Receives: Behavioral: Lifestyle |
| medication + tympanic tubing | Active comparator | anti-diuretics + tympanic tubing (under local anesthesia) Receives: Behavioral: Lifestyle |
| medication + regular sleep | Active comparator | anti-diuretics + regular sleep (regular sleep program under dark everynight) Receives: Behavioral: Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2015 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Meniere's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Investigators
- Tadashi Kitahara, M.D.,Ph.D., Principal investigator, Department of Otolaryngology, Osaka University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099046
- Sponsor's protocol ID
- yk19700512
- Acronym
- SMT
- Status last verified
- Apr 2010
- First submitted
- 27 Dec 2009
- Last updated
- 6 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19638944Kitahara 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.
PubMed 19094077Kitahara 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.
PubMed 18520184Horii 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.
PubMed 18219099Horii 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.
PubMed 15277036Kitahara 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.
PubMed 27362705
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Plasma Vasopressin Level in Patients With Meniere's Disease
- ClinicalTrials.gov ID
- NCT01099046
- Acronym / sponsor ID
- SMT / yk19700512
- Conditions
- Meniere's Disease, Stress
- Keywords
- Meniere's disease, stress management, vasopressin, V2 receptor, water intake, tympanic tubing, regular sleep under dark
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 6 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| medication only | No intervention | Behavioral: Lifestylemedication = anti-diuretics |
| medication + water intake | Active comparator | Behavioral: Lifestyleanti-diuretics + water intake (at least 2.0 litters per day) |
| medication + tympanic tubing | Active comparator | Behavioral: Lifestyleanti-diuretics + tympanic tubing (under local anesthesia) |
| medication + regular sleep | Active comparator | Behavioral: Lifestyleanti-diuretics + regular sleep (regular sleep program under dark everynight) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed as Meniere's patients according to the 1995 AAO-HNS criteria are included into this study.
Key exclusion criteria (1 listed)
- Patients refused our prepared four kinds of treatments are excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifestyleAlso: Stress Management Therapy (SMT)water intake, tympanic tubing, regular sleep | Behavioural | medication + regular sleep, medication + tympanic tubing, medication + water intake, medication only |
Primary outcome
all cause mortality
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2010.
- Background: PubMed 19638944Kitahara 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.
- Background: PubMed 19094077Kitahara 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.
- Background: PubMed 18520184Kitahara 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.
- Background: PubMed 18219099Horii 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.
- Background: PubMed 15277036Horii 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.
- Derived from this study: PubMed 27362705Kitahara 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.
Related trials for Meniere's Disease
Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Autoimmune Inner Ear Disease, Meniere's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadashi Kitahara, M.D.,Ph.D. principal investigator
Department of Otolaryngology, Osaka University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle in people with Meniere's Disease and Stress, run by Osaka University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tadashi Kitahara, M.D.,Ph.D. (+81-6-6879-3951 ext. 3951, tkitahara@ent.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01099046, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2010.