TinnitusNCT03552302
Effects of Yoga Exercise on Participates With Tinnitus
An observational study of Tinnitus, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2016to Dec 2018
- Phase
- Observational
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Tinnitus participates.
Who may be able to join
- 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.
Who cannot join
- Pregnant females or menopausal females with hormone replacement therapy.
- Hypertension
- Glaucoma.
- Those who cannot express their opinions or follow orders.
- Cancer patients.
- Objective tinnitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Yoga Exercise on Tinnitus Handicap and Sleep Quality of the 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Cases | Yoga exercise for 12 weeks Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Assessment of the degree of tinnitus
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.
Measured: 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 (1)
Assessment of the degree of sleep quality.
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.
Measured: 1. One week before yoga intervention. 2. Through study completion, an average of 12 week. 3. One month after the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study startSep 2016
- Primary completionAug 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juen-Haur Hwang, Ph. D., Study chair, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552302
- Sponsor's protocol ID
- B10503015
- Status last verified
- Dec 2018
- First submitted
- 7 Feb 2017
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga Exercise on Tinnitus Handicap and Sleep Quality of the Participates With Tinnitus
- ClinicalTrials.gov ID
- NCT03552302
- Acronym / sponsor ID
- B10503015
- Conditions
- Tinnitus
- Keywords
- Yoga, Tinnitus, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Jun 2018 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Behavioral: YogaYoga exercise for 12 weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Tinnitus participates.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Pregnant females or menopausal females with hormone replacement therapy.
- Hypertension
- Glaucoma.
- Those who cannot express their opinions or follow orders.
- Cancer patients.
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 |
|---|---|---|
| Yoga1. Yoga stretch warm-up exercise for 15 minutes. 2. Five kinds of yoga correction method for 30 minutes (abdominal breathing, throat breathing, wind box breathing, nasal alternating breathing, buzzing breathing). 3. Great rest for 15 minutes | Behavioural | Cases |
Primary outcome
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.
1 secondary outcome
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.
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 30 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
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.
Juen-Haur Hwang, Ph. D. study chair
Dalin Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
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 5 inclusion and 6 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 30 Aug 2021. 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 Taiwan. 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 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2021.