Effects of Yoga Exercise on Participates With Tinnitus

August 27, 2021 updated by: Dalin Tzu Chi General Hospital

Effects of Yoga Exercise on Tinnitus Handicap and Sleep Quality of the Participates With Tinnitus

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Chiayi City, Taiwan, 66247
        • Dalin Tzu Chi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic Tinnitus participates.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1. One week before yoga intervention. 2. Through study completion, an average of 12 week. 3. One month after the end of the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1. One week before yoga intervention. 2. Through study completion, an average of 12 week. 3. One month after the end of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalin Tzu Chi General Hospital

Investigators

  • Study Chair: Juen-Haur Hwang, Ph. D., Dalin Tzu Chi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

May 29, 2018

First Posted (Actual)

June 11, 2018

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B10503015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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