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Author: admin, 29.03.2015
Does it come and go?It’s not uncommon to experience a sudden high pitched ringing sound accompanied by a feeling of fullness that goes away quickly, and this is called transient ear noise. Learn moreAudiology Services at Sunnybrook Health Sciences Centre offers a Living With Tinnitus Workshop. About this siteYour Health Matters is a trusted source of health tips and information from Sunnybrook experts.
DisclaimerThe health tips on this website are for informational purposes only, and they are not intended to be a substitute for professional medical advice. Subjective tinnitus is a phantom sensation experienced in the absence of any source of sound. Completion of this trial will help to confirm whether ABVN or the combination of ABVN and sound stimulus plays a more important role in treating tinnitus. BackgroundSubjective tinnitus is considered as a phantom sensation experienced in the absence of any internal or external acoustic stimulus.
The trial will be performed according to the principles of the Declaration of Helsinki (Edinburgh version, 2000). Exclusion criteriaParticipants who experience or have one or more of the following conditions will be excluded:1.
ABVN groupAll participants will receive transcutaneous electrical stimulation at auricular acupoints innervated by the ABVN. DiscussionWe have presented the design and protocol for the randomized controlled clinical study for tinnitus patients. Trial statusThis trial is currently recruiting participants.ConsentWritten informed consent was obtained from the participants for publication of this manuscript and accompanying images. AcknowledgementsThe study was supported by the general scientific research project of traditional Chinese medicine approved by the Health and Family Planning Commission of Hubei Province, P.R.
Sunnybrook audiologist Enza Ciurlia-Guy provides an overview of this common health problem.
Tinnitus can sound like a number of different things, including pulsing, static, humming, whistling, ringing, chirping or squealing.
The majority of people with tinnitus have no idea what the actual cause is, but there are many potential triggers. Large doses of certain drugs – including anything with ASA as an active ingredient, some antibiotics and some anti-inflammatory medications – may also play a role.
About 15-20% of the general population, and between 70-85% of people with hearing loss, will experience tinnitus. With intermittent tinnitus, people have ear or head noise that lasts more than five minutes and happens intermittently.
The most important first step in the management of tinnitus is to see an ENT specialist and audiologist for a proper assessment. This 3-hour workshop allows individuals to share their experiences and learn about the condition. This pretty Pilgrim hematite plated grey crystal ring can be perfectly teamed with many of your favourite trends. Moreover, the result of this clinical trial will enhance our understanding of specific auricular acupoints. It can be perceived as a hissing, buzzing, humming, roaring, whistling, or ringing sound in one or both ears, or somewhere in the head. The points are located at the cymba conchae and the triangular fossa, where there is rich ABVN distribution [17]. If it proves successful, this new treatment method could offer hope to millions of patients who are affected by tinnitus.Although the exact pathophysiology of tinnitus still remains elusive, it is believed that an abnormal balance between inhibition and excitation causing map reorganization of central auditory circuits underlies many forms of tinnitus [26].
A copy of the written consent is available for review by the editor-in-chief of this journal.
The objective form of tinnitus is rare, and means both the individual and examiner can hear a sound.
Vagus nerve stimulation (VNS) is an exciting new method to treat tinnitus, but direct electrical stimulation of the cervical vagus has disadvantages.
At present, tinnitus has becoming the most common otology problem, affecting 10% to 30% of the general population and an estimated prevalence of 24.2% in the older population [1]. Before beginning the treatment, all candidates will undergo a standard neuro-otological examination and a baseline audiometric assessment, including measurement of hearing thresholds, minimal masking levels, loudness discomfort levels, and stapedial reflexes, performed by professional audiologists. Ethical permission was obtained from the Research Ethical Committee of Yichang Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, China Three Gorges University. Main stimulation points according to standard practice include Kidney (CO10), Yidan (CO11), Liver (CO12), and Shenmen (TF4). Assuming a 10% dropout rate, we plan to enroll a total of 120 participants with four groups of equal size (30 participants per group).Statistical analysisIn this trial, our primary outcome measure is the Tinnitus Handicap Inventory. Moreover, signs of abnormal activity were not only revealed in the central auditory system but also in non-auditory areas, including the limbic system [27-29]. SBY participated in designing the study and is in charge of treatment of patients in the ABVN plus tone group. This randomized controlled clinical trial aims to overcome these limitations by stimulating the auricular branch of vagus nerve (ABVN) on the outer ear.
The secondary outcome measure combines a visual analogue scale to measure tinnitus disturbance and loudness with the Hospital Anxiety and Depression Scale. The ethics committee approval number is 201407041.Recruitment period and methodsPatients will be enrolled in Yichang Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, China Three Gorges University with a target sample size of 120 subjects. This researcher informs the therapist of the treatment assignment.We applied a single-blind design in which the study patients, data collocation staff, and data analysts are blinded during the study protocol. We define the treatment response as a reduction in score on the Tinnitus Handicap Inventory following treatments of 20 points or more. The participants are informed of the potential benefits, risks, alternatives, and responsibilities during the study before they are asked to provide consent.
The annoyance of tinnitus is not correlated with its acoustic characteristics, but there is a significant correlation with psychological symptoms [30]. TTL drafted the manuscript and was responsible for obtaining approval from the Research Ethical Committee of Yichang Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, China Three Gorges University and registering the trial with the Chinese Clinical Trial Registry. Since the ABVN is the only peripheral branch of the vagus nerve distributed on the eara€™s surface, it should be possible to achieve analogous efficacy to VNS by activating the central vagal pathways. Assessment is planned at baseline (before treatment) and in the 4th and 8th week, with further follow-up visits after termination of the treatment at the 12th week. Among severe tinnitus sufferers, tinnitus-related sensations, such as anxiety, annoyance, frustration, and depression lead to a negative impact on quality of life in 70% of those affected [3], and they are usually told that they must learn to live with it. We will recruit the participants by advertising in the hospitals, in public newspapers and on the internet homepages of hospitals.


The therapists are not blinded to the treatments they deliver because treatment manipulation makes it impossible.
First, baseline characteristics will be analyzed using descriptive statistics for each group.
Potential mild adverse events, reported to be related to electro-acupuncture treatment, are pain, bleeding, tiredness, and a feeling of faintness in the acupuncture group [23], and skin redness and pressure marks in the other groups, but these mild symptoms will generally resolve spontaneously after treatment.
The autonomic nervous system is a major factor in the difference between simply perceiving tinnitus and being distressed by it [31].
However, researches have indicated that the curative effect lies in a combination of auditory and vagal nerve stimulation.
Yet the pathological mechanisms that underlie tinnitus perception remain largely hypothetical and are still not well understood. Two carbon-impregnated silicone electrode tips are connected to the transcutaneous electrical nerve stimulator by metal wire; one tip contacts the skin surface points and the other acts as a terminal end in the ear.
Then repeated measures analysis is performed to make comparisons among the treatment groups and the control group (ABVN plus tone versus electrical acupuncture, non-ABVN plus tone versus electrical acupuncture, and ABVN versus electrical acupuncture) at different time points (4th, 8th, and 12th week).
Studies have reported that tinnitus distress correlated positively with sympathetic markers and negatively with parasympathetic markers [32,33]. Moreover, from traditional Chinese theory, auricular acupoints used to treat tinnitus are mainly in the regions supplied by the ABVN.
Currently, the universally accepted hypothesis is that interactions between altered cochlear inputs and distorted central auditory processing provoke tinnitus.
If a significant difference is found, the next step is to make comparisons among the three treatment groups in effectiveness. For instance, an ear-cough reflex (Arnolda€™s reflex) is estimated to be present in approximately 4% [24] of the general population, while there is rare occurrence of ear-gag reflex, ear-lacrimal reflex and auricular syncope [24,25].
Accumulating evidence illustrates that tinnitus is correlated with symptoms of distress, such as emotional stress and depression for the important role of the limbic system in the pathophysiology of tinnitus, which is based on the further understanding of auditory-limbic interactions [34-36].Vagal nerve stimulation was developed based on this growing understanding of tinnitus. Whether stimulation at the auricular acupoints is due to unintentional stimulation of vagal afferent fibers also needs evidence. Studies have supported that subjective tinnitus may be a result of the expression of neural plasticity and that anomalies may develop because of decreased input from the ear, deprivation and sound stimulation, overstimulation or other factors as yet unknown. TF4, CO10-12, and HX1 are used in the ABVN group and the ABVN plus tone group; HX9 and LO5 are used in the non-ABVN plus tone group.
So there is a rare possibility that patients in the two groups receiving ABVN stimulation might have these reflexes. It may work by activating the nucleus of the solitary tract, which, in turn, may activate the locus coeruleus and nucleus basalis, which release neuromodulators that have significant effects on learning and memory and in plasticity regulation by modulating neurons in the cortex, hippocampus, and amygdala [26]. Multiple tones will be delivered by Tinnitus Measurer software (Neonix, USA) at a comfortable listening level during the transcutaneous electrical nerve stimulation.
Participants who show any adverse effects during the course of the therapy will receive appropriate treatment immediately.
Engineer and colleagues [8] have indicated that cervical VNS paired with specific auditory stimuli completely eliminated the physiological and behavioral correlates of the phantom sound.
SZZ is responsible for central randomization and statistical analysis and made amendments to the manuscript. No physiotherapy treatments can yet be considered sufficient in providing long-term reduction of tinnitus impact and there is no drug approved by the European Medicines Agency or the Food and Drug Administration on the market [4,5]. Randomly interleaved pure tones that span the hearing range but exclude the tinnitus tone will be selected. All adverse effects will be documented, and patients with persistent worsening symptoms will be withdrawn from the study. They observed that pairing tones with VNS significantly acutely increased excitability and suppressed spontaneous multi-unit activity in rat auditory cortex [37]. Therefore, an effective and safe therapy for tinnitus is of considerable importance to meet this significant unmet clinical need.Vagus nerve stimulation (VNS) is approved by the Food and Drug Administration for both refractory epilepsy and resistant depression [6,7]. Indeed, beneficial effects in relieving psychological symptoms have been confirmed in patients with tinnitus using invasive VNS pairing tones [21] or transcutaneous VNS paired with tones [19,38] in recent small sample pilot studies. VNS offers an exciting new perspective for the treatment of tinnitus and it has recently been demonstrated that VNS is a promising method [8]. However, another experiment also demonstrated that VNS-directed long-lasting reversal of pathological neural plasticity is driven by the repeated association of VNS with tones, and not by VNS alone [8]. In this method, an electrode surgically implanted around the left cervical vagus nerve is connected to a pulse generator placed subcutaneously in the upper chest.
German researchers [14] claimed that no clinically relevant improvement of tinnitus complaints was observed after transcutaneous VNS alone. However, considering the disadvantages of the implantation, including lesions of the vagus nerve, infection, shortness of breath, possible mechanical failure of electronic equipment, and battery replacement, a relatively safe and well tolerated improved method is desired. To some extent, this may confirm the suggestion that stimulation at ABVN might prove less effective than VNS because fibers from the auricular branch do not primarily target the nucleus of the solitary tract and so only target it partly. To minimize side effects, stimulation of the auricular branch of vagus nerve (ABVN) has been suggested [9].
Otherwise, as these researchers themselves suggested [14], the most probable explanation is that VNS alone is not effective in reducing tinnitus, which is supported by the work of Engineer et al. Prevalence of leisure noise-induced tinnitus and the attitude toward noise in university students. The ABVN is the only peripheral branch of the vagus nerve distributed on the surface of ear, and studies using the transganglionic horseradish peroxidase method [10,11] have shown that it mainly projects to the nucleus of the solitary tract in the brainstem. Functional magnetic resonance imaging and vagus sensory evoked potentials revealed that ABVN stimulation shows considerable similarity to implanted VNS, with both acting through the central auditory pathway of the vagus nerve [12,13].
Patients will be in a comfortable and relaxed position and asked to concentrate on the treatment task.
While sound stimulus alone, as a common sensory exposure treatment strategy, has been applied to treat tinnitus for many years [39,40], studies have indicated that it has only provided some temporary relief [41,42]. Thus, it would be safer simply to deliver mild electric shocks to the skin of the outer ear instead of resorting to VNS with surgery.
Therefore, to identify whether ABVN or the combination of ABVN and sound stimulus plays a more important role in relieving tinnitus, we designed this four-armed novel trial to determine their specific effect on tinnitus.Acupuncture is an important part of traditional Chinese medicine. However, some researchers reported that ABVN stimulation alone seems to have no relevant improvement of tinnitus complaints [8,14], and it is suggested that the combination with other interventions, such as sound stimuli, which would reduce the cortical response to mid-frequency tones, increase frequency selectivity, and decrease cortical synchronization [15] should be considered.
It has been accepted in China for thousands of years and is now used as an alternative and complementary medical therapy in Western countries. But there is not currently enough evidence in clinical practice of the effect of the method of pairing tones with stimulation at ABVN.Moreover, auricular acupuncture, the underlying mechanism of which is unclear, has been used to treat tinnitus for thousands of years [16]. All parameters of the electrical stimulation inducing twitching of the muscles indicate effective stimulus.


Meta-analysis results have indicated that acupuncture or acupuncture combined with other therapies is superior to medication alone or non-acupuncture treatments in treating subjective tinnitus [43]. Auricular acupoints applied to treat tinnitus such as Kidney (CO10), Yidan (CO11), Liver (CO12) and Shenmen (TF4) are distributed in the regions supplied by ABVN [17].
However, in another systematic review, acupuncture for the treatment of tinnitus has not been demonstrated to be efficacious [44].
So whether auricular acupoints are due to an unintentional stimulation of the vagal afferent fibers also needs more clinical and experimental evidence.Therefore, we have designed a randomized, four-arm, controlled clinical study to provide a conclusive answer. Whether acupuncture is effective or not in the treatment of tinnitus is a question worthy of discussion. In this trial, our aim is to attempt to confirm whether ABVN or the combination of ABVN and sound stimulus plays a more important role in the treatment of tinnitus.
Electrical acupuncture is performed by a therapist with rich clinical experience and acupuncture licenses for Chinese medicine practitioners from the Ministry of Health of China. According to the theory of traditional Chinese medicine, the shaoyang meridians of the hand and foot travel to the ear region, so acupoints of the shaoyang meridians located both in local and distant areas of the ear are used to treat tinnitus in this protocol. In addition, the specific acupoints Yifeng (TE17), Tinghui (GB2), Xiaxi (GB43), and Zhongzhu (TE3) are usually chosen in treating tinnitus.Auricular acupuncture, as an important branch of acupuncture, has also been utilized in the treatment of diseases for years. Each question of the Tinnitus Handicap Inventory can be answered by either a€?oftena€™ (4 points), a€?sometimesa€™ (2 points), or a€?nevera€™ (0 points). In ancient Chinaa€™s earliest medical text Huang Di Nei Jing, which was compiled in the 5th century BC, the correlation between the external ear and the body or viscera is described. The total score allows the tinnitus to be categorized as: a€?slighta€™ (0 to 16 points), a€?milda€™ (18 to 36 points), a€?moderatea€™ (38 to 56 points), a€?severea€™ (58 to 76 points), or a€?catastrophica€™ (78 to 100 points). The assessment is at baseline (before randomization), and in the 4th and 8th week, with further follow-up visits after termination of the treatment at the 12th week.Secondary outcome measuresA visual analogue scale, measuring the disturbance and the loudness of the tinnitus will be used. Paul Nogier, a physician in France, first originated the concept of an inverted fetus map on the external ear [45]. He proposed a theory that there is a somatotopic and viscerotopic representation on the auricle [46]. According to these theories, disorders from a particular part of the body or viscera can be treated by the corresponding points in the ear [46,47]. A score of 0 to 7 for either subscale could be regarded as being in the normal range, a score of 8 to 10 is just suggestive of the presence of the respective state and a score of 11 or higher indicates the probable presence of the mood disorder [20]. Therefore, related auricular acupoints such as Kidney (CO10), Yidan (CO11), or Liver (CO12) are usually selected to treat tinnitus, which, according to the organ-viscera theory of traditional Chinese medicine, results from insufficient Kidney qi or dampness-heat of the Liver and Gallbladder. Both of these assessments will be used at baseline (before randomization), and in the 4th and 8th week, with further follow-up visits after termination of the treatment at the 12th week.Statistical methodsThe trial aims to detect a difference between the four study groups. It is often utilized to remedy mental illnesses or psychiatric disorders, such as insomnia [50], anxiety [51,52], or tinnitus [53].
This is deemed a clinically significant difference of a 20-point or greater reduction in score on the Tinnitus Handicap Inventory following treatments.
However, the physiological mechanisms associated with these auricular acupoints remain unclear.
In this study, it is proposed that the autonomic and the central nervous system could be modified by auricular vagal stimulation via projection from the ABVN to the nucleus of the solitary tract [54], which might work through the neuromodulator system, thus directing plasticity to treat tinnitus.However, our study has several potential limitations. However, the Tinnitus Handicap Inventory [55,56], visual analogue scale [56], and Hospital Anxiety and Depression Scale [57] have been much used in most of the randomized controlled trials on tinnitus and they are proved to be efficient in reflecting the subjective emotional changes related to tinnitus. Second, this trial is single-blind, therefore, the subjective factors from therapists might bias the outcome assessments. However, it is hard to blind the therapists, who are required to be familiar with treatments for the specific grouping assignment.
Central distribution of primary afferent fibers in the Arnolda€™s nerve (the auricular branch of the vagus nerve): a transganglionic HRP study in the cat.
It does not lend results to great generalizability to more diverse sets of patients in more diverse regions. Morphological basis of auricular acupuncture effects: evidences from neural tracer method of HRP. A large sample, multicenter, and objective measures to assess the effectiveness of treatment should be included in a future study.
BOLD fMRI deactivation of limbic and temporal brain structures and mood enhancing effect by transcutaneous vagus nerve stimulation. Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study.
Treatment of tinnitus with electrical stimulation on acupoint in the distribution area of ear vagus nerve combining with sound masking: randomized controlled trial. Safety and efficacy of vagus nerve stimulation paired with tones for the treatment of tinnitus: a case series. The impact of auditory cortex activity on characterizing and treating patients with chronic tinnitus-first results from a PET study.
Neuroimaging and neuromodulation: complementary approaches for identifying the neuronal correlates of tinnitus. Neuronal connectivity and interactions between the auditory and limbic systems: effects of noise and tinnitus. Structural brain changes in tinnitus: grey matter decrease in auditory and non-auditory brain areas. Vagus nerve stimulation modulates cortical synchrony and excitability through the activation of muscarinic receptors. Listening to tailor-made notched music reduces tinnitus loudness and tinnitus-related auditory cortex activity.
An experimental evaluation of auricular diagnosis: the somatotopic mapping or musculoskeletal pain at ear acupuncture points.
Which tinnitus-related aspects are relevant for quality of life and depression: results from a large international multicentre sample. Correlation analysis of the visual-analogue scale and the Tinnitus Handicap Inventory in tinnitus patients. The Hospital Anxiety and Depression Scale (HAD) as a screening instrument in tinnitus evaluation.



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