TinnitusEMDRNCT03218046
EMDR as a Treatment for Tinnitus
A study testing EMDR in people with Tinnitus, run by Julie Dawson at 1 site in United Kingdom.
Trial summary
Tinnitus may be considered as a form of phantom auditory sensation and as such parallels may be drawn with other forms of phantom sensation, such as the sensation of pain in an amputated limb (phantom limb pain). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- EMDR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to 2 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 'Subjective Idiopathic Tinnitus', specifically 'Chronic Decompensated Tinnitus' with a THI score of 38 to 100.
- 2. Tinnitus for greater than 6 months duration. 3. Aged over 18 4. Willing to commit to a full course of EMDR therapy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
About this study
Official title: Eye Movement Desensitisation and Reprocessing (EMDR) as a Treatment for Tinnitus: A Feasibility Study
Tinnitus may be considered as a form of phantom auditory sensation and as such parallels may be drawn with other forms of phantom sensation, such as the sensation of pain in an amputated limb (phantom limb pain). There has been recent interest in the use of eye movement therapies to treat patients with phantom sensations such as these. The role of eye movements in the propagation and maintenance of tinnitus has also been well established. The main aim of this study is to evaluate the effectiveness of an established form of eye movement therapy called Eye Movement Desensitisation and Reprocessing (EMDR). This research is important as EMDR has produced encouraging results for other forms of phantom sensation and current models of tinnitus fit well with the proposed mode of action of EMDR. Tinnitus is very prevalent in our population and is often associated with significant discomfort; however, there is a severe lack of effective treatments based on well designed clinical trials. The investigator wishes to assess the usefulness of EMDR against the current treatment that is available in many institutions including the Investigator's own. The Investigator intends to recruit 15-30 patients initially to run a pilot study, before embarking on a larger scale study. The Investigator hopes that this pilot study will run over the course of a year. If this study demonstrates a significant improvement in tinnitus in patient undergoing EMDR, this will be an important step forward not only for treating patients with this disorder, but also for understanding the pathways that initiate, propagate and maintain tinnitus perception.
Read the detailed description
Tinnitus is a common, yet poorly understood condition. In the UK, a large study using data from more than 500,000 people has found a prevalence of tinnitus of 16.2% (defined as any noise in the ear/s lasting longer than five minutes) and a prevalence of bothersome tinnitus as 3.8% (those who were moderately or severely bothered by their tinnitus on a four point Likert scale). Other international studies have also found a high prevalence of 30% with a total of 6% of the study population reporting incapacitating symptoms from tinnitus. Despite the high worldwide prevalence of tinnitus and the large number of proposed therapies available, there is a distinct paucity of well controlled trials in the literature to support an effective treatment.
Tinnitus may be considered as a form of phantom auditory perception and as such parallels may be drawn with other forms of phantom sensation, there has been recent interest in the use of eye movement therapies to treat patients with phantom sensations such as phantom limb pain. Both studies of those with tinnitus and phantom limb pain have suggested a psychological component such as certain premorbid personality traits may also contribute or predispose to these conditions and consequently be helped by psychological therapies.
Eye Movement Desensitisation and Reprocessing (EMDR) was first described by Shapiro in 1989 and requires the subject to perform relatively rapid movements of the eyes. Its application has been particularly documented in the context of post-traumatic stress disorder (PTSD). EMDR has been described as an integrative psychotherapy, due to its assimilation of various elements from diverse psychotherapies. A number of models have been proposed to account for the role of eye movements in EMDR, these include Shapiro's Adaptive Information Processing Model, Dyck's conditioning model, attentional processing accounts and theories of reverse learning . A recurrent mechanism in a number of these accounts is that of the orientating reflex. MacCollock and Feldman argue that lateral eye-movements trigger an investigatory component of this reflex to assess safety with regard to potential external threats . Where threats are positively identified, a flight or flight response is initiated; in situations where no danger is identified a functional reduction in arousal takes place. Support for this reassurance response in non-clinical patients has been demonstrated using auditory stimuli. Overlap between these concepts and theories related to the perception of tinnitus bode well, especially when one considers the neurophysiological model proposed by Jastreboff.
Since its introduction in 1989, numerous controlled studies have been conducted to evaluate EMDR's utility as a treatment for various forms of trauma-related complaints, including PTSD. The positive results have established EMDR as an effective trauma treatment and have prompted numerous professional organisations to recognise its efficacy, beginning with the American Psychological Association's (APA) Division 12 Task Force on Psychological Interventions in 1998. Since then, the NHS the International Society for Traumatic Stress Studies , the Israeli National Council for Mental Health , and the Northern Ireland Department of Health have also supported EMDR. Most recently, the US Departments of Defence and Veterans Affairs stated that EMDR was an effective treatment of trauma, as did the American Psychiatric Association . It has also been found to be helpful in medically unexplained symptoms and somatoform disorders.
Other forms of eye movement therapy have been popularised, such as eye movement integration therapy (EMI) in which eye movements in specific directions provide access strategies to different sensory domains. EMI was originally developed from research in the field of neuro-linguistic programming (NLP) and has also been widely used in the treatment of PTSD. EMI uses slower eye movements that are thought to access internal dialogue or emotional and feeling areas of the brain. Initially the concept of specifically accessing domains associated with auditory-based cue was appealing as a therapy for an auditory based pathology, however, despite initial enthusiasm for EMI the specificity of these associations has been disputed.
The role of eye movements in the propagation and maintenance of tinnitus has been well established, although the exact neurophysiological mechanisms of how eye movements integrate within the central auditory areas is not fully understood, however functional imaging has suggested a number of neuroanatomical sites. Cognitive science has provided neural networks that model tinnitus, these neural network models were inspired by theoretical models that described possible neural mechanisms mediating tinnitus. The majority of these models rely on the lateral-inhibition network (LIN) to simulate tinnitus and focus on the role of central auditory processing regions as possible anatomical locations of the physiological abnormalities that cause tinnitus. Recent work has identified a number of regions responsible for the generation and modulation of tinnitus including limbic, somatosensory and motor areas.
There has been some encouraging work described in the German literature regarding the effectiveness of EMDR for the treatment of tinnitus. The application of eye movement therapies to treat patients with tinnitus would seem logical considering the context our current understanding of tinnitus; the next step would be to test this theory in the setting of a formal randomised controlled clinical study.
- Conditions
- Tinnitus
- Being tested
- EMDR
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDRBehavioural
Eye Movement Desensitisation and Reprocessing
| Study group | Role | What they receive |
|---|---|---|
| EMDR group | Experimental | This is the treatment arm that will receive EMDR therapy Receives: Behavioral: EMDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tinnitus handicap inventory score
Tinnitus questionnaire
Measured: 6 months
Secondary outcomes (7)
Beck Depression Inventory (T0, T1, T2)
Depression questionnaire
Measured: 6 months
Beck Anxiety Inventory(T0, T1, T2)
Anxiety questionnaire
Measured: 6 months
Posttraumatic Stress Diagnostic Scale (T0, T1, T2)
Post traumatic stress questionnaire
Measured: 6 months
Pure Tone Audiogram (T0).
Hearing test
Measured: 6 months
Psychoacoustic parameters: (T0, T1, T2) a. Intensity - Tinnitus loudness estimate using a VAS b. Loudness Discomfort Level (LDL) at 250-8000Hz
Quasi objective measure of tinnitus
Measured: 6 months
Five factor personality inventory (T0)
Personality questionnaire
Measured: 6 months
Free text evaluation of treatment and trial protocol (T2)
Open appraisal of study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study startJul 2016
- Primary completion31 Aug 2017
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Dawson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
- Investigators
- John Phillips, Principal investigator, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218046
- Sponsor's protocol ID
- 174629
- Acronym
- EMDR
- Status last verified
- Jul 2019
- First submitted
- 20 Dec 2016
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lockwood AH, Salvi RJ, Burkard RF. Tinnitus. N Engl J Med. 2002 Sep 19;347(12):904-10. doi: 10.1056/NEJMra013395. No abstract available.
PubMed 12239260Noell CA, Meyerhoff WL. Tinnitus. Diagnosis and treatment of this elusive symptom. Geriatrics. 2003 Feb;58(2):28-34.
PubMed 12596495Davis A, El Rafaie A. Epidemiology of tinnitus. In: Tyler RS, (ed). Tinnitus Handbook. San Diego: Singular, 2000; 1-23.
McFerran DJ, Phillips JS. Tinnitus. J Laryngol Otol. 2007 Mar;121(3):201-8. doi: 10.1017/S0022215106002714. Epub 2006 Sep 25.
PubMed 16995967Oren, E. and R. Solomon (2012).
Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.
PubMed 12849487Shapiro F. Efficacy of the eye movement desensitization procedure in the treatment of traumatic memories. J Trauma Stress. 1989;2(2):199-223.
Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.
PubMed 17636720Shapiro F. Eye Movement Desensitization and Reprocessing (EMDR): Basic Principles, Protocols, and Procedures, 2nd Edition. 2001. The Guilford Press.
Dyck MJ. A proposal for a conditioning model of eye movement desensitization treatment for posttraumatic stress disorder. J Behav Ther Exp Psychiatry. 1993 Sep;24(3):201-10. doi: 10.1016/0005-7916(93)90022-o.
PubMed 7910613Kuiken D, Bears M, Miall D, Smith L. Eye Movement Desensitisation Reprocessing Facilitates Attentional Orienting. Imagination, Cognition and Personality. 2002;21:3-20.
Hassard A. Reverse learning and the physiological basis of eye movement desensitization. Med Hypotheses. 1996 Oct;47(4):277-82. doi: 10.1016/s0306-9877(96)90067-5.
PubMed 8910876MacCulloch MJ, Feldman P. Eye movement desensitisation treatment utilises the positive visceral element of the investigatory reflex to inhibit the memories of post-traumatic stress disorder: a theoretical analysis. Br J Psychiatry. 1996 Nov;169(5):571-9. doi: 10.1192/bjp.169.5.571.
PubMed 8932885Barrowcliff AL, Gray NS, MacCulloch S, Freeman TC, MacCulloch MJ. Horizontal rhythmical eye movements consistently diminish the arousal provoked by auditory stimuli. Br J Clin Psychol. 2003 Sep;42(Pt 3):289-302. doi: 10.1348/01446650360703393.
PubMed 14565894Jastreboff PJ. Phantom auditory perception (tinnitus): mechanisms of generation and perception. Neurosci Res. 1990 Aug;8(4):221-54. doi: 10.1016/0168-0102(90)90031-9.
PubMed 2175858
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Movement Desensitisation and Reprocessing (EMDR) as a Treatment for Tinnitus: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03218046
- Acronym / sponsor ID
- EMDR / 174629
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Julie DawsonUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tinnitus may be considered as a form of phantom auditory sensation and as such parallels may be drawn with other forms of phantom sensation, such as the sensation of pain in an amputated limb (phantom limb pain). There has been recent interest in the use of eye movement therapies to treat patients with phantom sensations such as these. The role of eye movements in the propagation and maintenance of tinnitus has also been well established. The main aim of this study is to evaluate the effectiveness of an established form of eye movement therapy called Eye Movement Desensitisation and Reprocessing (EMDR). This research is important as EMDR has produced encouraging results for other forms of phantom sensation and current models of tinnitus fit well with the proposed mode of action of EMDR. Tinnitus is very prevalent in our population and is often associated with significant discomfort; however, there is a severe lack of effective treatments based on well designed clinical trials. The investigator wishes to assess the usefulness of EMDR against the current treatment that is available in many institutions including the Investigator's own. The Investigator intends to recruit 15-30 patients initially to run a pilot study, before embarking on a larger scale study. The Investigator hopes that this pilot study will run over the course of a year. If this study demonstrates a significant improvement in tinnitus in patient undergoing EMDR, this will be an important step forward not only for treating patients with this disorder, but also for understanding the pathways that initiate, propagate and maintain tinnitus perception.
Detailed description
Tinnitus is a common, yet poorly understood condition. In the UK, a large study using data from more than 500,000 people has found a prevalence of tinnitus of 16.2% (defined as any noise in the ear/s lasting longer than five minutes) and a prevalence of bothersome tinnitus as 3.8% (those who were moderately or severely bothered by their tinnitus on a four point Likert scale). Other international studies have also found a high prevalence of 30% with a total of 6% of the study population reporting incapacitating symptoms from tinnitus. Despite the high worldwide prevalence of tinnitus and the large number of proposed therapies available, there is a distinct paucity of well controlled trials in the literature to support an effective treatment.
Tinnitus may be considered as a form of phantom auditory perception and as such parallels may be drawn with other forms of phantom sensation, there has been recent interest in the use of eye movement therapies to treat patients with phantom sensations such as phantom limb pain. Both studies of those with tinnitus and phantom limb pain have suggested a psychological component such as certain premorbid personality traits may also contribute or predispose to these conditions and consequently be helped by psychological therapies.
Eye Movement Desensitisation and Reprocessing (EMDR) was first described by Shapiro in 1989 and requires the subject to perform relatively rapid movements of the eyes. Its application has been particularly documented in the context of post-traumatic stress disorder (PTSD). EMDR has been described as an integrative psychotherapy, due to its assimilation of various elements from diverse psychotherapies. A number of models have been proposed to account for the role of eye movements in EMDR, these include Shapiro's Adaptive Information Processing Model, Dyck's conditioning model, attentional processing accounts and theories of reverse learning . A recurrent mechanism in a number of these accounts is that of the orientating reflex. MacCollock and Feldman argue that lateral eye-movements trigger an investigatory component of this reflex to assess safety with regard to potential external threats . Where threats are positively identified, a flight or flight response is initiated; in situations where no danger is identified a functional reduction in arousal takes place. Support for this reassurance response in non-clinical patients has been demonstrated using auditory stimuli. Overlap between these concepts and theories related to the perception of tinnitus bode well, especially when one considers the neurophysiological model proposed by Jastreboff.
Since its introduction in 1989, numerous controlled studies have been conducted to evaluate EMDR's utility as a treatment for various forms of trauma-related complaints, including PTSD. The positive results have established EMDR as an effective trauma treatment and have prompted numerous professional organisations to recognise its efficacy, beginning with the American Psychological Association's (APA) Division 12 Task Force on Psychological Interventions in 1998. Since then, the NHS the International Society for Traumatic Stress Studies , the Israeli National Council for Mental Health , and the Northern Ireland Department of Health have also supported EMDR. Most recently, the US Departments of Defence and Veterans Affairs stated that EMDR was an effective treatment of trauma, as did the American Psychiatric Association . It has also been found to be helpful in medically unexplained symptoms and somatoform disorders.
Other forms of eye movement therapy have been popularised, such as eye movement integration therapy (EMI) in which eye movements in specific directions provide access strategies to different sensory domains. EMI was originally developed from research in the field of neuro-linguistic programming (NLP) and has also been widely used in the treatment of PTSD. EMI uses slower eye movements that are thought to access internal dialogue or emotional and feeling areas of the brain. Initially the concept of specifically accessing domains associated with auditory-based cue was appealing as a therapy for an auditory based pathology, however, despite initial enthusiasm for EMI the specificity of these associations has been disputed.
The role of eye movements in the propagation and maintenance of tinnitus has been well established, although the exact neurophysiological mechanisms of how eye movements integrate within the central auditory areas is not fully understood, however functional imaging has suggested a number of neuroanatomical sites. Cognitive science has provided neural networks that model tinnitus, these neural network models were inspired by theoretical models that described possible neural mechanisms mediating tinnitus. The majority of these models rely on the lateral-inhibition network (LIN) to simulate tinnitus and focus on the role of central auditory processing regions as possible anatomical locations of the physiological abnormalities that cause tinnitus. Recent work has identified a number of regions responsible for the generation and modulation of tinnitus including limbic, somatosensory and motor areas.
There has been some encouraging work described in the German literature regarding the effectiveness of EMDR for the treatment of tinnitus. The application of eye movement therapies to treat patients with tinnitus would seem logical considering the context our current understanding of tinnitus; the next step would be to test this theory in the setting of a formal randomised controlled clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMDR group | Experimental | Behavioral: EMDRThis is the treatment arm that will receive EMDR therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. 'Subjective Idiopathic Tinnitus', specifically 'Chronic Decompensated Tinnitus' with a THI score of 38 to 100.
- 2. Tinnitus for greater than 6 months duration. 3. Aged over 18 4. Willing to commit to a full course of EMDR therapy
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDREye Movement Desensitisation and Reprocessing | Behavioural | EMDR group |
Primary outcome
Change in tinnitus handicap inventory score
Time frame: 6 months
Tinnitus questionnaire
7 secondary outcomes
Beck Depression Inventory (T0, T1, T2)
Time frame: 6 months
Beck Anxiety Inventory(T0, T1, T2)
Time frame: 6 months
Posttraumatic Stress Diagnostic Scale (T0, T1, T2)
Time frame: 6 months
Pure Tone Audiogram (T0).
Time frame: 6 months
Psychoacoustic parameters: (T0, T1, T2) a. Intensity - Tinnitus loudness estimate using a VAS b. Loudness Discomfort Level (LDL) at 250-8000Hz
Time frame: 6 months
Five factor personality inventory (T0)
Time frame: 6 months
Free text evaluation of treatment and trial protocol (T2)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Background: PubMed 12239260Lockwood AH, Salvi RJ, Burkard RF. Tinnitus. N Engl J Med. 2002 Sep 19;347(12):904-10. doi: 10.1056/NEJMra013395. No abstract available.
- Background: PubMed 12596495Noell CA, Meyerhoff WL. Tinnitus. Diagnosis and treatment of this elusive symptom. Geriatrics. 2003 Feb;58(2):28-34.
- BackgroundDavis A, El Rafaie A. Epidemiology of tinnitus. In: Tyler RS, (ed). Tinnitus Handbook. San Diego: Singular, 2000; 1-23.
- Background: PubMed 16995967McFerran DJ, Phillips JS. Tinnitus. J Laryngol Otol. 2007 Mar;121(3):201-8. doi: 10.1017/S0022215106002714. Epub 2006 Sep 25.
- BackgroundOren, E. and R. Solomon (2012).
- Background: PubMed 12849487Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.
- BackgroundShapiro F. Efficacy of the eye movement desensitization procedure in the treatment of traumatic memories. J Trauma Stress. 1989;2(2):199-223.
- Background: PubMed 17636720Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.
- BackgroundShapiro F. Eye Movement Desensitization and Reprocessing (EMDR): Basic Principles, Protocols, and Procedures, 2nd Edition. 2001. The Guilford Press.
- Background: PubMed 7910613Dyck MJ. A proposal for a conditioning model of eye movement desensitization treatment for posttraumatic stress disorder. J Behav Ther Exp Psychiatry. 1993 Sep;24(3):201-10. doi: 10.1016/0005-7916(93)90022-o.
- BackgroundKuiken D, Bears M, Miall D, Smith L. Eye Movement Desensitisation Reprocessing Facilitates Attentional Orienting. Imagination, Cognition and Personality. 2002;21:3-20.
- Background: PubMed 8910876Hassard A. Reverse learning and the physiological basis of eye movement desensitization. Med Hypotheses. 1996 Oct;47(4):277-82. doi: 10.1016/s0306-9877(96)90067-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Phillips principal investigator
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR in people with Tinnitus, run by Julie Dawson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tinnitus handicap inventory score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03218046, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.