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Completed

NCT Number: NCT03552302

Effects of Yoga Exercise on 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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dalin Tzu Chi General Hospital

Chiayi City, 66247, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant females or menopausal females with hormone replacement therapy.
  • Hypertension
  • Glaucoma.
  • Those who cannot express their opinions or follow orders.
  • Cancer patients.
  • Objective tinnitus.

Treatment and study plan

Yoga

Behavioral
  • 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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dalin Tzu Chi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 11, 2018
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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