Tinnitus, SubjectiveNCT06360731
The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus
A study testing 4-7-8 breathing exercise technique and informative session on tinnitus and Informative session on tinnitus in people with Tinnitus, Subjective, run by Ege University at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this study is to evaluate the effect of 4-7-8 breathing exercise on tinnitus handicap, psychological factors and sleep quality. There will be a parallel-group randomized controlled trial study and consists of two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- 4-7-8 breathing exercise technique and informative session on tinnitus and Informative session on tinnitus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Mar 2024to 7 Jun 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-65 years with subjective idiopathic tinnitus complaints for at least six months
- Must be able to speak and read Turkish
- Must be able to answer the questionnaire questions and perform the 4-7-8 breathing exercises regularly
Who cannot join
- Any neuro-otologic, psychiatric, neurologic, or cognitive problems, objective tinnitus, chronic medication use, asthma diagnosis or respiratory distress
- Receivement of any tinnitus treatment or tinnitus informative session actively
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gokce Saygi Uysal
Ankara
Audiology Unit of the Department of Otorhinolaryngology, Ege University Faculty of Medicine Hospital
Izmir
About this study
Official title: The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus Handicap, Psychological Factors, and Sleep Quality in Tinnitus Patients: A Randomized Controlled Study
The goal of this study is to evaluate the effect of 4-7-8 breathing exercise on tinnitus handicap, psychological factors and sleep quality.
There will be a parallel-group randomized controlled trial study and consists of two groups.
Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks. Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory, and perceived stress scale will be applied before and after the application.
Read the detailed description
The aim of this study is to evaluate the effect of 4-7-8 breathing exercise technique on tinnitus handicap, psychological factors and sleep quality. It is also aimed to compare the results of the experimental group and those who received only 1 hour of informative session on tinnitus (Control group).
The study will employ a parallel-group randomized controlled trial design. Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks.
Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory,and perceived stress scale will be applied to all patients before and after the application.
- Conditions
- Tinnitus, Subjective
- Being tested
- 4-7-8 breathing exercise technique and informative session on tinnitus, Informative session on tinnitus
- Keywords
- 4-7-8 breathing exercise, Tinnitus, Psychological factors, Insomnia, Informative session
- Medical subject headings
- Tinnitus, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-7-8 breathing exercise technique and informative session on tinnitusOther
Participants in experimental group will be individually provided with informative session on tinnitus for one hour by researchers. During the informative session, the participants will be given general information about tinnitus and will be informed about the possible causes, symptoms, diagnosis, therapy, or treatment processes, and coping methods. The participants will be also given a printed informative brochure on tinnitus. In the same session, after one hour of informative session, the 4-7-8 breathing exercise method will be demonstrated by the same researchers. In addition, a video showing how to perform the 4-7-8 breathing exercise technique will be sent as a text message to their cell phones.
Informative session on tinnitusOther
Participants in control group will be individually provided with informative session on tinnitus only for one hour by researchers G.K. and G.S.U. from both clinics. During the informative session, the participants will be given general information about tinnitus and inform about the possible causes, symptoms, diagnosis, therapy, or treatment processes, and coping methods. The participants will be also given a printed informative brochure on tinnitus.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental group who consists of subjective tinnitus patients will receive 1 hour of informative session on tinnitus and also perform 4-7-8 breathing exercises for 6 weeks Receives: Other: 4-7-8 breathing exercise technique and informative session on tinnitus |
| Control Group | Active comparator | Control group who consists of subjective tinnitus patients will receive 1 hour of informative session on tinnitus only Receives: Other: Informative session on tinnitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Patients will be asked to assess the degree of distress and annoyance associated with their tinnitus, as well as its severity, using a Visual Analog Scale (VAS) from 0 to 10 both before and after the application. An increase in these areas is shown by an increase in the score. Minimum score value is 0 and maximum value is 10. All patients will be assessed before application.
Measured: Baseline
Visual Analog Scale (VAS)
Patients will be asked to assess the degree of distress and annoyance associated with their tinnitus, as well as its severity, using a Visual Analog Scale (VAS) from 0 to 10 both before and after the application. An increase in these areas is shown by an increase in the score. Minimum score value is 0 and maximum value is 10. All patients will be assessed six weeks after baseline evaluation.
Measured: Six weeks after baseline evaluation
Tinnitus Handicap Inventory (THI)
The Tinnitus Handicap Inventory (THI) assesses the catastrophic, emotional, and functional impacts of tinnitus and measures its effects on patients' daily functioning. The THI consists of 25 items. In the inventory, there are 25 items consisting of three options as 'yes', 'no', and 'sometimes'. A 'yes' answer is worth 4 points and a 'no' answer is worth 0 points. A maximum score of 100 points can be obtained from the THI. The higher the score, the greater the perception of the tinnitus as a handicap. Minimum score value is 0 and maximum value is 100. All patients will be assessed before application.
Measured: Baseline
Tinnitus Handicap Inventory (THI)
The Tinnitus Handicap Inventory (THI) assesses the catastrophic, emotional, and functional impacts of tinnitus and measures its effects on patients' daily functioning. The THI consists of 25 items. In the inventory, there are 25 items consisting of three options as 'yes', 'no', and 'sometimes'. A 'yes' answer is worth 4 points and a 'no' answer is worth 0 points. A maximum score of 100 points can be obtained from the THI. The higher the score, the greater the perception of the tinnitus as a handicap. Minimum score value is 0 and maximum value is 100. All patients will be assessed six weeks after baseline evaluation.
Measured: Six weeks after baseline evaluation
Insomnia severity index (ISI)
Sleep quality of the patients was assessed with the insomnia severity index (ISI). It is a questionnaire that evaluates the difficulties experienced in transitioning to and maintaining sleep, the level of stress caused by sleep problems, and impairments in daily functions, and thus determines the level of insomnia. It consists of 7 questions in total. Higher score indicates more insomnia symptoms. Minimum score value is 0 and maximum value is 28. All patients will be assessed before application.
Measured: Baseline
Insomnia severity index (ISI)
Sleep quality of the patients was assessed with the insomnia severity index (ISI). It is a questionnaire that evaluates the difficulties experienced in transitioning to and maintaining sleep, the level of stress caused by sleep problems, and impairments in daily functions, and thus determines the level of insomnia. It consists of 7 questions in total. Higher score indicates more insomnia symptoms. Minimum score value is 0 and maximum value is 28. All patients will be assessed six weeks after baseline evaluation.
Measured: Six weeks after baseline evaluation
Perceived stress scale -10 (PSS-10)
The Perceived Stress Scale-10 (PSS-10) will be administered to assess the stress perceived by tinnitus patients. It was developed to measure the extent to which situations in one's life are considered stressful. It consists of 10 questions. The scores of PSS-10 vary between 0 and 40. Greater perceived stress is indicated by higher scores. The scores of PSS-10 vary between 0 and 40. All patients will be assessed before application.
Measured: Baseline
Perceived stress scale -10 (PSS-10)
The Perceived Stress Scale-10 (PSS-10) will be administered to assess the stress perceived by tinnitus patients. It was developed to measure the extent to which situations in one's life are considered stressful. It consists of 10 questions. The scores of PSS-10 vary between 0 and 40. Greater perceived stress is indicated by higher scores. The scores of PSS-10 vary between 0 and 40. All patients will be assessed six weeks after baseline evaluation.
Measured: Six weeks after baseline evaluation
Trait Anxiety Scale (TAS)
The trait anxiety subscale of the State-Trait Anxiety Inventory was used to assess the level of anxiety in those with tinnitus. The TAS is a 4-point Likert-type scale consisting of twenty items that aims to determine how the individual feels regardless of the situation and conditions in which they find themselves. A score between 20 and 80 is obtained from this scale. Higher scores indicate higher level of anxiety. A score between 20 and 80 is obtained from this scale. All patients will be assessed before application.
Measured: Baseline
Trait Anxiety Scale (TAS)
The trait anxiety subscale of the State-Trait Anxiety Inventory was used to assess the level of anxiety in those with tinnitus. The TAS is a 4-point Likert-type scale consisting of twenty items that aims to determine how the individual feels regardless of the situation and conditions in which they find themselves. A score between 20 and 80 is obtained from this scale. Higher scores indicate higher level of anxiety. A score between 20 and 80 is obtained from this scale. All patients will be assessed six weeks after baseline evaluation.
Measured: Six weeks after baseline evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start18 Mar 2024
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a parallel group randomised controlled trial design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulce Kirazli, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360731
- Sponsor's protocol ID
- 1018
- Status last verified
- Jun 2024
- First submitted
- 5 Apr 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koksoy S, Eti CM, Karatas M, Vayisoglu Y. The Effects of Yoga in Patients Suffering from Subjective Tinnitus. Int Arch Otorhinolaryngol. 2018 Jan;22(1):9-13. doi: 10.1055/s-0037-1601415. Epub 2017 Apr 3.
PubMed 29379573Vierra J, Boonla O, Prasertsri P. Effects of sleep deprivation and 4-7-8 breathing control on heart rate variability, blood pressure, blood glucose, and endothelial function in healthy young adults. Physiol Rep. 2022 Jul;10(13):e15389. doi: 10.14814/phy2.15389.
PubMed 35822447Gilles A, Jacquemin L, Cardon E, Vanderveken OM, Joossen I, Vermeersch H, Vanhecke S, Van den Brande K, Michiels S, Van de Heyning P, Van Rompaey V. Long-term effects of a single psycho-educational session in chronic tinnitus patients. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3301-3307. doi: 10.1007/s00405-021-07026-7. Epub 2021 Oct 1.
PubMed 34596715Apoorva HM, Jayaram M, Patil NJ. Usefulness of Yoga in the management of tinnitus during COVID-19: A narrative review. J Ayurveda Integr Med. 2024 Jan-Feb;15(1):100822. doi: 10.1016/j.jaim.2023.100822. Epub 2023 Dec 28.
PubMed 38157657Ismail AMA, Ali SM, Ghuiba K, Elfahl AMA, Tolba AMN, Ghaleb HAM. Autonomic functions, tinnitus annoyance and loudness, and quality of life: Randomized-controlled responses to bee-humming (vibrational) respiratory training in tinnitus elderly. Complement Ther Clin Pract. 2022 Aug;48:101611. doi: 10.1016/j.ctcp.2022.101611. Epub 2022 Jun 3.
PubMed 35675742Gunjawate DR, Ravi R. Effect of yoga and meditation on tinnitus: a systematic review. J Laryngol Otol. 2021 Apr;135(4):284-287. doi: 10.1017/S0022215121000566. Epub 2021 Mar 11.
PubMed 33691808Video: breathing exercises: 4-7-8 breath [Internet]. 2014 Available from: https://www.drweil.com/videos-features/videos/breathing-exercises-4-7-8-breath/
Aksoy S, Firat Y, Alpar R. The Tinnitus Handicap Inventory: a study of validity and reliability. Int Tinnitus J. 2007;13(2):94-8.
PubMed 18229787Boysan M, Güleç M, Beşiroğlu L, et al. Psychometric properties of the Insomnia Severity Index in Turkish sample. Anadolu Psikiyatri Derg 2010;11:248-252.
Eskin M, Harlak H, Demirkıran F. The adaptation of the perceived stress scale into turkish: a reliability and validity analysis. Neuropsych Investig 2013;51:132-140.
Öner N, Lecompte A. Manual of state trait anxiety inventory. Istanbul: Boğaziçi University Print House; 1998.
Kirazli G, Baran S, Uysal GS, Ozdogan A, Durankaya SM, Ogut MF. The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus Handicap, Psychological Factors, and Sleep Quality in Tinnitus Patients: A Randomized Controlled Study. Brain Behav. 2026 Feb;16(2):e70854. doi: 10.1002/brb3.70854.
PubMed 41676854
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus Handicap, Psychological Factors, and Sleep Quality in Tinnitus Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06360731
- Acronym / sponsor ID
- 1018
- Conditions
- Tinnitus, Subjective
- Keywords
- 4-7-8 breathing exercise, Tinnitus, Psychological factors, Insomnia, Informative session
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 11 Apr 2024 (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.
The goal of this study is to evaluate the effect of 4-7-8 breathing exercise on tinnitus handicap, psychological factors and sleep quality.
There will be a parallel-group randomized controlled trial study and consists of two groups.
Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks. Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory, and perceived stress scale will be applied before and after the application.
Detailed description
The aim of this study is to evaluate the effect of 4-7-8 breathing exercise technique on tinnitus handicap, psychological factors and sleep quality. It is also aimed to compare the results of the experimental group and those who received only 1 hour of informative session on tinnitus (Control group).
The study will employ a parallel-group randomized controlled trial design. Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks.
Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory,and perceived stress scale will be applied to all patients before and after the application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study employs a parallel group randomised controlled trial design.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: 4-7-8 breathing exercise technique and informative session on tinnitusExperimental group who consists of subjective tinnitus patients will receive 1 hour of informative session on tinnitus and also perform 4-7-8 breathing exercises for 6 weeks |
| Control Group | Active comparator | Other: Informative session on tinnitusControl group who consists of subjective tinnitus patients will receive 1 hour of informative session on tinnitus only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18-65 years with subjective idiopathic tinnitus complaints for at least six months
- Must be able to speak and read Turkish
- Must be able to answer the questionnaire questions and perform the 4-7-8 breathing exercises regularly
Key exclusion criteria (2 listed)
- Any neuro-otologic, psychiatric, neurologic, or cognitive problems, objective tinnitus, chronic medication use, asthma diagnosis or respiratory distress
- Receivement of any tinnitus treatment or tinnitus informative session actively
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 |
|---|---|---|
| 4-7-8 breathing exercise technique and informative session on tinnitusParticipants in experimental group will be individually provided with informative session on tinnitus for one hour by researchers. During the informative session, the participants will be given general information about tinnitus and will be informed about the possible causes, symptoms, diagnosis, therapy, or treatment processes, and coping methods. The participants will be also given a printed informative brochure on tinnitus. In the same session, after one hour of informative session, the 4-7-8 breathing exercise method will be demonstrated by the same researchers. In addition, a video showing how to perform the 4-7-8 breathing exercise technique will be sent as a text message to their cell phones. | Other | Experimental Group |
| Informative session on tinnitusParticipants in control group will be individually provided with informative session on tinnitus only for one hour by researchers G.K. and G.S.U. from both clinics. During the informative session, the participants will be given general information about tinnitus and inform about the possible causes, symptoms, diagnosis, therapy, or treatment processes, and coping methods. The participants will be also given a printed informative brochure on tinnitus. | Other | Control Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline
Patients will be asked to assess the degree of distress and annoyance associated with their tinnitus, as well as its severity, using a Visual Analog Scale (VAS) from 0 to 10 both before and after the application. An increase in these areas is shown by an increase in the score. Minimum score value is 0 and maximum value is 10. All patients will be assessed before application.
Visual Analog Scale (VAS)
Time frame: Six weeks after baseline evaluation
Patients will be asked to assess the degree of distress and annoyance associated with their tinnitus, as well as its severity, using a Visual Analog Scale (VAS) from 0 to 10 both before and after the application. An increase in these areas is shown by an increase in the score. Minimum score value is 0 and maximum value is 10. All patients will be assessed six weeks after baseline evaluation.
Tinnitus Handicap Inventory (THI)
Time frame: Baseline
The Tinnitus Handicap Inventory (THI) assesses the catastrophic, emotional, and functional impacts of tinnitus and measures its effects on patients' daily functioning. The THI consists of 25 items. In the inventory, there are 25 items consisting of three options as 'yes', 'no', and 'sometimes'. A 'yes' answer is worth 4 points and a 'no' answer is worth 0 points. A maximum score of 100 points can be obtained from the THI. The higher the score, the greater the perception of the tinnitus as a handicap. Minimum score value is 0 and maximum value is 100. All patients will be assessed before application.
Tinnitus Handicap Inventory (THI)
Time frame: Six weeks after baseline evaluation
The Tinnitus Handicap Inventory (THI) assesses the catastrophic, emotional, and functional impacts of tinnitus and measures its effects on patients' daily functioning. The THI consists of 25 items. In the inventory, there are 25 items consisting of three options as 'yes', 'no', and 'sometimes'. A 'yes' answer is worth 4 points and a 'no' answer is worth 0 points. A maximum score of 100 points can be obtained from the THI. The higher the score, the greater the perception of the tinnitus as a handicap. Minimum score value is 0 and maximum value is 100. All patients will be assessed six weeks after baseline evaluation.
Insomnia severity index (ISI)
Time frame: Baseline
Sleep quality of the patients was assessed with the insomnia severity index (ISI). It is a questionnaire that evaluates the difficulties experienced in transitioning to and maintaining sleep, the level of stress caused by sleep problems, and impairments in daily functions, and thus determines the level of insomnia. It consists of 7 questions in total. Higher score indicates more insomnia symptoms. Minimum score value is 0 and maximum value is 28. All patients will be assessed before application.
Insomnia severity index (ISI)
Time frame: Six weeks after baseline evaluation
Sleep quality of the patients was assessed with the insomnia severity index (ISI). It is a questionnaire that evaluates the difficulties experienced in transitioning to and maintaining sleep, the level of stress caused by sleep problems, and impairments in daily functions, and thus determines the level of insomnia. It consists of 7 questions in total. Higher score indicates more insomnia symptoms. Minimum score value is 0 and maximum value is 28. All patients will be assessed six weeks after baseline evaluation.
Perceived stress scale -10 (PSS-10)
Time frame: Baseline
The Perceived Stress Scale-10 (PSS-10) will be administered to assess the stress perceived by tinnitus patients. It was developed to measure the extent to which situations in one's life are considered stressful. It consists of 10 questions. The scores of PSS-10 vary between 0 and 40. Greater perceived stress is indicated by higher scores. The scores of PSS-10 vary between 0 and 40. All patients will be assessed before application.
Perceived stress scale -10 (PSS-10)
Time frame: Six weeks after baseline evaluation
The Perceived Stress Scale-10 (PSS-10) will be administered to assess the stress perceived by tinnitus patients. It was developed to measure the extent to which situations in one's life are considered stressful. It consists of 10 questions. The scores of PSS-10 vary between 0 and 40. Greater perceived stress is indicated by higher scores. The scores of PSS-10 vary between 0 and 40. All patients will be assessed six weeks after baseline evaluation.
Trait Anxiety Scale (TAS)
Time frame: Baseline
The trait anxiety subscale of the State-Trait Anxiety Inventory was used to assess the level of anxiety in those with tinnitus. The TAS is a 4-point Likert-type scale consisting of twenty items that aims to determine how the individual feels regardless of the situation and conditions in which they find themselves. A score between 20 and 80 is obtained from this scale. Higher scores indicate higher level of anxiety. A score between 20 and 80 is obtained from this scale. All patients will be assessed before application.
Trait Anxiety Scale (TAS)
Time frame: Six weeks after baseline evaluation
The trait anxiety subscale of the State-Trait Anxiety Inventory was used to assess the level of anxiety in those with tinnitus. The TAS is a 4-point Likert-type scale consisting of twenty items that aims to determine how the individual feels regardless of the situation and conditions in which they find themselves. A score between 20 and 80 is obtained from this scale. Higher scores indicate higher level of anxiety. A score between 20 and 80 is obtained from this scale. All patients will be assessed six weeks after baseline evaluation.
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 1 Jul 2024.
- Background: PubMed 29379573Koksoy S, Eti CM, Karatas M, Vayisoglu Y. The Effects of Yoga in Patients Suffering from Subjective Tinnitus. Int Arch Otorhinolaryngol. 2018 Jan;22(1):9-13. doi: 10.1055/s-0037-1601415. Epub 2017 Apr 3.
- Background: PubMed 35822447Vierra J, Boonla O, Prasertsri P. Effects of sleep deprivation and 4-7-8 breathing control on heart rate variability, blood pressure, blood glucose, and endothelial function in healthy young adults. Physiol Rep. 2022 Jul;10(13):e15389. doi: 10.14814/phy2.15389.
- Results publication: PubMed 34596715Gilles A, Jacquemin L, Cardon E, Vanderveken OM, Joossen I, Vermeersch H, Vanhecke S, Van den Brande K, Michiels S, Van de Heyning P, Van Rompaey V. Long-term effects of a single psycho-educational session in chronic tinnitus patients. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3301-3307. doi: 10.1007/s00405-021-07026-7. Epub 2021 Oct 1.
- Results publication: PubMed 38157657Apoorva HM, Jayaram M, Patil NJ. Usefulness of Yoga in the management of tinnitus during COVID-19: A narrative review. J Ayurveda Integr Med. 2024 Jan-Feb;15(1):100822. doi: 10.1016/j.jaim.2023.100822. Epub 2023 Dec 28.
- Results publication: PubMed 35675742Ismail AMA, Ali SM, Ghuiba K, Elfahl AMA, Tolba AMN, Ghaleb HAM. Autonomic functions, tinnitus annoyance and loudness, and quality of life: Randomized-controlled responses to bee-humming (vibrational) respiratory training in tinnitus elderly. Complement Ther Clin Pract. 2022 Aug;48:101611. doi: 10.1016/j.ctcp.2022.101611. Epub 2022 Jun 3.
- Results publication: PubMed 33691808Gunjawate DR, Ravi R. Effect of yoga and meditation on tinnitus: a systematic review. J Laryngol Otol. 2021 Apr;135(4):284-287. doi: 10.1017/S0022215121000566. Epub 2021 Mar 11.
- Results publicationVideo: breathing exercises: 4-7-8 breath [Internet]. 2014 Available from: https://www.drweil.com/videos-features/videos/breathing-exercises-4-7-8-breath/
- Results publication: PubMed 18229787Aksoy S, Firat Y, Alpar R. The Tinnitus Handicap Inventory: a study of validity and reliability. Int Tinnitus J. 2007;13(2):94-8.
- Results publicationBoysan M, Güleç M, Beşiroğlu L, et al. Psychometric properties of the Insomnia Severity Index in Turkish sample. Anadolu Psikiyatri Derg 2010;11:248-252.
- Results publicationEskin M, Harlak H, Demirkıran F. The adaptation of the perceived stress scale into turkish: a reliability and validity analysis. Neuropsych Investig 2013;51:132-140.
- Results publicationÖner N, Lecompte A. Manual of state trait anxiety inventory. Istanbul: Boğaziçi University Print House; 1998.
- Derived from this study: PubMed 41676854Kirazli G, Baran S, Uysal GS, Ozdogan A, Durankaya SM, Ogut MF. The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus Handicap, Psychological Factors, and Sleep Quality in Tinnitus Patients: A Randomized Controlled Study. Brain Behav. 2026 Feb;16(2):e70854. doi: 10.1002/brb3.70854.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-7-8 breathing exercise technique and informative session on tinnitus and Informative session on tinnitus in people with Tinnitus, Subjective, run by Ege University at 2 sites in Turkey (Türkiye).
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 3 inclusion and 2 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Visual Analog Scale (VAS) (time frame: Baseline). The study lists 10 primary outcomes in all. 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 NCT06360731, which also lists 12 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 1 Jul 2024.