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
|Condition or disease||Intervention/treatment|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
Yoga exercise for 12 weeks
- 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.
- 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.
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
|Contact: Juen-Haur Hwang, Ph. D.||+886-5-2648000 ext firstname.lastname@example.org|
|Dalin Tzu Chi General Hospital||Recruiting|
|Chiayi City, Taiwan, 66247|
|Contact: Juen-Haur Hwang, Ph. D. +886-5-2648000 ext 5239 email@example.com|
|Study Chair:||Juen-Haur Hwang, Ph. D.||Dalin Tzu Chi General Hospital|