跳至主要内容
临床试验/CTRI/2024/10/075000
CTRI/2024/10/075000尚未招募不适用

The Effect of Yoga Intervention in Subjects with Tinnitus on Audiological Parameters

Dr Sanjay Munjal1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
scores of tinnitus handicap inventory and Tinnitus severity index questionnaire will be compared for all patients wit tinnitus

研究概览

简要总结

summary: Tinnitus remains one of most devastating auditory handicaps. Tinnitus is any ringing sensation that can be heard by the person himself without any external stimuli being presented. People with Tinnitus often have difficulty sleeping and concentrating at work, and are annoyed and get anxious thus leading to degraded quality of life of these individuals. It has been estimated that as many as 6-20% of the population experiences a form severe enough to interfere with daily activity. Many consider or are driven to suicide. Moreover, it must be emphasized that there is a relation between Tinnitus and the activity of the prefrontal cortex and limbic system. This part of the brain is related to emotions, thus the association with depression, anxiety and other psychological diseases can be made when Tinnitus is severe hence making it the target of most of the investigations.Innumerable treatments for this condition have been utilized with varying degrees of success by clinicians and patients. The goal of effective Tinnitus management is not necessary to mask or remove the patient’s physical perception of Tinnitus associated sounds. According to Duckro et al "treatment of chronic Tinnitus is more accurately described in terms of management rather than cure"(1). A realistic goal of an effective Tinnitus management program is to help patients understand and gain control over their disease, rather than latter having control over them. Ultimately clinicians should strive to help patients progress to the point where Tinnitus is no longer a negative factor in their lives. Available treatments for management of Tinnitus are diverse. More evidence is available for cognitive-behavioural therapies. Further established treatments include counselling, various forms of sound therapies, methods that attempt to increase input to auditory system, such as hearing aids and cochlear implants, pharmacological treatments, neuro-biofeedback, various forms of electrical stimulation of brain structures, inducing electric current in brain with transcranial direct current stimulation or rTMS. However, evidence for effectiveness of these different treatment strategies is scarce. These therapies present different results among the patients due to different etiologies of Tinnitus. Therefore, a comprehensive evaluation of underlying etiology is mandatory prior to commencement of treatment. Yoga is an ancient and holistic system originated from India, which involves physical postures (asana), breathing exercises (Pranayama) and meditation (shavasana and yoganidra). Yoga has been reported to reduce sympathetic hormones, stimulate the limbic 27 system and activate antagonistic neuromuscular systems. There are various studies about the therapeutic effects of Yoga in reducing anxiety, stress, depression, sleeping disorders, insomnia and hypertension. Many studies have concluded that yoga increases the levels of GABA (gamma-amino butyric acid) which is an inhibitory neurotransmitter which inhibits the electrical activity and thus reduces tinnitus, anxiety as well as depression. Pandey et al, 2010 reported positive effects of Bhramari Pranayam which is a form of yoga in which eyelids are closed followed by relaxation posture along with humming on exhalation. It was found that there was positive effect of this yogic form on physical and emotional features of tinnitus. Thus, he concluded that this particular form of yogic form can be given to individuals who have tinnitus. A recent study done by Köksoy et al, 2022 studied the effect of yoga in patients having subjective tinnitus. Here tinnitus scores before and after yoga sessions was calculated. The scores showed significant results indicating less handicap scores, stress and severity. A systemic review done by Gunjawate et al, 2021 on five studies concluded that yoga has positive effects on tinnitus like reduced stress and anxiety and improved quality of life. All of these parameters were based on subjective parameters. However, most of the studies have not given any difference in audiological parameters. Based on this, we aim to investigate to the effect of Yoga intervention in Tinnitus patients by assessing audiological parameters. Tinnitus remains one of most devastating auditory handicaps. Tinnitus is any ringing sensation that can be heard by the person himself without any external stimuli being presented. People with Tinnitus often have difficulty sleeping and concentrating at work, and are annoyed and get anxious thus leading to degraded quality of life of these individuals. It has been estimated that as many as 6-20% of the population experiences a form severe enough to interfere with daily activity. Many consider or are driven to suicide. Moreover, it must be emphasized that there is a relation between Tinnitus and the activity of the prefrontal cortex and limbic system. This part of the brain is related to emotions, thus the association with depression, anxiety and other psychological diseases can be made when Tinnitus is severe hence making it the target of most of the investigations. Innumerable treatments for this condition have been utilized with varying degrees of success by clinicians and patients. The goal of effective Tinnitus management is not necessary to mask or remove the patient’s physical perception of Tinnitus associated sounds. According to Duckro et al "treatment of chronic Tinnitus is more accurately described in terms of management rather than cure"(1). A realistic goal of an effective Tinnitus management program is to help patients understand and gain control over their disease, rather than latter having control over them. Ultimately clinicians should strive to help patients progress to the point where Tinnitus is no longer a negative factor in their lives. Available treatments for management of Tinnitus are diverse. More evidence is available for cognitive-behavioural therapies. Further established treatments include counselling, various forms of sound therapies, methods that attempt to increase input to auditory system, such as hearing aids and cochlear implants, pharmacological treatments, neuro-biofeedback, various forms of electrical stimulation of brain structures, inducing electric current in brain with transcranial direct current stimulation or rTMS. However, evidence for effectiveness of these different treatment strategies is scarce. These therapies present different results among the patients due to different etiologies of Tinnitus. Therefore, a comprehensive evaluation of underlying etiology is mandatory prior to commencement of treatment. Yoga is an ancient and holistic system originated from India, which involves physical postures (asana), breathing exercises (Pranayama) and meditation (Shavasana and yoganidra). Yoga has been reported to reduce sympathetic hormones, stimulate the limbic 27 system and activate antagonistic neuromuscular systems. There are various studies about the therapeutic effects of Yoga in reducing anxiety, stress, depression, sleeping disorders, insomnia and hypertension. Many studies have concluded that yoga increases the levels of GABA (gamma-amino butyric acid) which is an inhibitory neurotransmitter which inhibits the electrical activity and thus reduces tinnitus, anxiety as well as depression. Pandey et al, 2010 reported positive effects of Bhramari Pranayam which is a form of yoga in which eyelids are closed followed by relaxation posture along with humming on exhalation. It was found that there was positive effect of this yogic form on physical and emotional features of tinnitus. Thus, he concluded that this particular form of yogic form can be given to individuals who have tinnitus. A recent study done by Köksoy et al, 2022 studied the effect of yoga in patients having subjective tinnitus. Here tinnitus scores before and after yoga sessions was calculated. The scores showed significant results indicating less handicap scores, stress and severity. A systemic review done by Gunjawate et al, 2021 on five studies concluded that yoga has positive effects on tinnitus like reduced stress and anxiety and improved quality of life. All of these parameters were based on subjective parameters. However, most of the studies have not given any difference in audiological parameters. Based on this, we aim to investigate to the effect of Yoga intervention in Tinnitus patients by assessing audiological parameters

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Subjects having Tinnitus in the age range of 20-50 years.
  • Subjects with healthy external and middle ear on clinical examination.
  • Subjects having tinnitus for at least more than 4 weeks.
  • Subjects who will give their consent to the request of the investigator for the assessments.

排除标准

  • 未提供

结局指标

主要结局

scores of tinnitus handicap inventory and Tinnitus severity index questionnaire will be compared for all patients wit tinnitus

时间窗: BASELINE | 3 MONTHS | 6 MONTHS

次要结局

  • audiological parameters(Tinnitus severity index)

研究者

发起方
Dr Sanjay Munjal
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Sanjay Munjal

Post Graduate Institute of Medical Education and Research

研究点 (1)

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