Clinical trial NCT03552302: Effects of Yoga Exercise on Participates With Tinnitus
Official title: Effects of Yoga Exercise on Tinnitus Handicap and Sleep Quality of the Participates With Tinnitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus
Keywords: Yoga
Tinnitus
Sleep
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Tinnitus participates.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change from Assessment of the degree of tinnitus
timeFrame: 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 outcomes:
measure: Assessment of the degree of sleep quality.
timeFrame: 1. One week before yoga intervention. 2. Through study completion, an average of 12 week. 3. One month after the end of the study.
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Dalin Tzu Chi General Hospital
Study officials:
affiliation: Dalin Tzu Chi General Hospital
name: Juen-Haur Hwang, Ph. D.
role: STUDY_CHAIR
References: