Effects of Yoga Exercise on Participates With Tinnitus

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552302
• Other study ID #: B10503015
• Status: Completed
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Dalin Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

Behavioral:
• Yoga
Yoga stretch warm-up exercise for 15 minutes. Five kinds of yoga correction method for 30 minutes (abdominal breathing, throat breathing, wind box breathing, nasal alternating breathing, buzzing breathing). Great rest for 15 minutes

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi General Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Assessment of the degree of tinnitus	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	Assessment of the degree of sleep quality.	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.