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Effects of Yoga Exercise on Participates With Tinnitus

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ClinicalTrials.gov Identifier: NCT03552302
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Dalin Tzu Chi General Hospital

Brief Summary:
This study aimed to investigate the effectiveness of Yoga on the tinnitus handicap and sleep quality in humans. We selected adult participates with chronic tinnitus (>6 months). All participates performed Yoga exercise once per week at outpatient department under the guidance of a professional teacher, and performed once daily by themselves at home for 12 weeks. Questionnaires of Tinnitus Handicap Inventory and Pittsburgh Sleep Quality Index were measured before the start of this study, at the end of this study, and 1 month after the end of this study.

Condition or disease Intervention/treatment
Tinnitus Behavioral: Yoga

Detailed Description:

Tinnitus is the auditory phantom sensation in the absence of external sound stimulation. Tinnitus that persisted more than six months without improvement can be called chronic tinnitus. One report proposed the neurophysiological model of tinnitus. In addition, tinnitus patients suffered from insomnia, irritability, anxiety and/or depression.

Current management of tinnitus is a drug-based treatment and/or nutritional supplementation. Music therapy, hearing aid therapy, and tinnitus retraining therapy (TRT), were also applied for patients with tinnitus. Even though, success rates of various tinnitus treatments were still unsatisfactory till now.

This study aimed to investigate the effectiveness of Yoga on the tinnitus handicap and sleep quality in humans. We selected adult participates with chronic tinnitus (>6 months). All participates performed Yoga exercise once per week at outpatient department under the guidance of a professional teacher, and performed once daily by themselves at home for 12 weeks. Questionnaires of Tinnitus Handicap Inventory and Pittsburgh Sleep Quality Index were measured before the start of this study, at the end of this study, and 1 month after the end of this study.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Yoga Exercise on Tinnitus Handicap and Sleep Quality of the Participates With Tinnitus
Actual Study Start Date : September 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases
Yoga exercise for 12 weeks
Behavioral: Yoga
  1. Yoga stretch warm-up exercise for 15 minutes.
  2. Five kinds of yoga correction method for 30 minutes (abdominal breathing, throat breathing, wind box breathing, nasal alternating breathing, buzzing breathing).
  3. Great rest for 15 minutes




Primary Outcome Measures :
  1. Change from Assessment of the degree of tinnitus [ Time Frame: 1. One week before yoga intervention. 2. Through study completion, an average of 12 week. 3. One month after the end of the study. ]
    Chinese version of Tinnitus Handicap Inventory (THI). There were 25 questions and totally 100 points in THI. The answer for each questions is classified into three levels (will, sometimes, will not), and answering "will" gave 4 points, answering "sometimes" gave 2 points, and answering "will not " gave 0 points. The higher the total scores, the more severe the tinnitus.


Secondary Outcome Measures :
  1. Assessment of the degree of sleep quality. [ Time Frame: 1. One week before yoga intervention. 2. Through study completion, an average of 12 week. 3. One month after the end of the study. ]
    Chinese version of Pittsburgh Sleep Quality Index (PSQI). There were 18 counted items and totally 21 points. The answer for each questions is classified into four levels (frequent, sometimes, rare, never), and answering "frequent" gave 3 points, answering "sometimes" gave 2 points, answering "rare" gave 1 point, and answering "never" gave 0 point. The higher the total scores, the more severe the sleep problem.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic Tinnitus participates.
Criteria

Inclusion Criteria:

  1. Participates with tinnitus persisted more than 6 months from ear, nose, and throat out-patient department.
  2. No drug treatment for their tinnitus in recent 3 months.
  3. No respiratory diseases (eg, asthma).
  4. Normal cognitive function.
  5. Normal language comprehension.

Exclusion Criteria:

  1. Pregnant females or menopausal females with hormone replacement therapy.
  2. Hypertension
  3. Glaucoma.
  4. Those who cannot express their opinions or follow orders.
  5. Cancer patients.
  6. Objective tinnitus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552302


Contacts
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Contact: Juen-Haur Hwang, Ph. D. +886-5-2648000 ext 5239 juenhaur@ms96.url.com.tw

Locations
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Taiwan
Dalin Tzu Chi General Hospital Recruiting
Chiayi City, Taiwan, 66247
Contact: Juen-Haur Hwang, Ph. D.    +886-5-2648000 ext 5239    juenhaur@ms96.url.com.tw   
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Investigators
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Study Chair: Juen-Haur Hwang, Ph. D. Dalin Tzu Chi General Hospital

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Responsible Party: Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03552302     History of Changes
Other Study ID Numbers: B10503015
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dalin Tzu Chi General Hospital:
Yoga
Tinnitus
Sleep
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms