COVID-19NCT05621967
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
A study testing Tonation Breathing Techniques, Music Driven Vocal Exercises and Silent Breathing in people with COVID-19, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
To investigate Phonation therapy to improve symptoms and lung physiology in patients referred for pulmonary rehabilitation. The study design will be a randomized controlled trial. The primary outcome is improvement in patient symptoms (Borg dyspnea score). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Tonation Breathing Techniques, Music Driven Vocal Exercises and Silent Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to 21 Jun 2023
- 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
- Age 18 years and older
- English-speaking and reading patient
- Able to consent for study
- Referred for pulmonary rehabilitation for chronic lung disease (including long COVID19 syndrome, COPD, ILD, PH)
- Baseline Borg dyspnea score as moderate (score 3) or higher.
- Has baseline pulmonary function testing available in electronic medical record.
Who cannot join
- Cannot commit to staying an extra 30 min after Pulmonary Rehabilitation sessions for the study.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate Phonation therapy to improve symptoms and lung physiology in patients referred for pulmonary rehabilitation. The study design will be a randomized controlled trial. The primary outcome is improvement in patient symptoms (Borg dyspnea score). Secondary outcomes are improvement in time of breath hold, forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), negative inspiratory force (NIF) and improvement in quality of life. The investigators will be investigating tonation breathing techniques (TBT) exercises and music-driven vocal exercises (MDVE). The study population would be patients who are referred to pulmonary rehabilitation (PR) for symptomatic chronic lung disease. The calculated sample size for the study would be 16 patients and the duration of the study would be 8 weeks. The study would be performed after the participant's pulmonary rehabilitation session.
Read the detailed description
Patients who are referred for pulmonary rehabilitation for chronic lung disease and/or post-COVID19 therapy, and who have had pulmonary function testing already will be approached. Pulmonary rehabilitation is an 8-week program (meeting 3 times per week for the 8 weeks). Pulmonary rehabilitation (PR) is the standard of care for patients with chronic lung diseases and or post-COVID-19 therapy. Eligible study participants will be called prior to their introductory PR session to explain the research project, and those who are interested will be given full information and offered time to ask questions. The investigators find this necessary for logistics, given many of the PR patients rely on scheduled transportation to/from PR and this will allow those who are interested in obtaining more information and to consent to the study to arrange for appropriate transportation. Informed consent will be done in person on an individual basis at their introductory PR session, with 1:1 discussion with the study staff and the patient.
As this is a pilot study to determine feasibility, and preliminary data (as no data are currently available for this patient population), the investigators propose 16 participants in total, 4 in each arm of the study. Randomization will occur by random number generator (1-4 for each arm proposed).
Once informed consent is obtained, patients will be randomized to 4 arms of the study. Randomization will be performed using a random number generator.
- Comparing tonation breathing technique (TBT) to normal breathing:
- Of the 8 weeks of PR, first 4 weeks will be sessions of normal breathing exercises for 20 minutes, then subsequent 4 weeks will be with TBT intervention for 20 minutes.
- Of the 8 weeks of PR, the first 4 weeks will be with TBT intervention for 20 minutes, then the next 4 weeks will be of sessions of normal breathing exercises for 20 minutes.
- Comparing MDVE to normal breathing:
- Of the 8 weeks of PR, the first 4 weeks will be sessions of normal breathing exercises for 20 minutes, then the subsequent 4 weeks will be with Music Driven Vocal Exercises (MDVE) intervention for 20 minutes.
- Of the 8 weeks of PR, the first 4 weeks will be with MDVE intervention for 20 minutes, then the next 4 weeks will be of sessions of normal breathing exercises for 20 minutes.
These interventions would be performed after the usual PR time when patients would be normally discharged home. Therefore, no additional monitoring is expected.
Pulmonary function testing is standard for all patients who receive PR - testing before and after PR is routine clinical course. The investigators propose an additional pulmonary function test (PFT) study at 4 weeks, as part of the research protocol (covered by the Department of Medicine funding)
In summary, the interventions for research purposes will include:
- 20-minute sessions after PR for intervention (TBT or MDVE) or normal breathing for twice a week for the 8 weeks they are participating in PR.
- PFT at end of week 4
Proposed subjective outcomes are routinely asked of PR patients, but will be collected at baseline, at 4 weeks (mid-way), and at 8 weeks (end) of PR. Proposed objective outcomes:
- For FEV1, FVC - these are routinely collected at baseline and at end of PR. The investigators propose an additional PFT study at 4 weeks, covered by the DOM Faculty Development Fund.
- For peak flow and NIF - these are procedures that ask for patients to breathe maximally for inspiration and expiration. They are not routine measures collected but are routine bedside measurements for pulmonary patients that can be collected for any person without any additional risk or cost.
- Conditions
- COVID-19
- Being tested
- Tonation Breathing Techniques, Music Driven Vocal Exercises, Silent Breathing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonation Breathing TechniquesBehavioural
Also called TBT
Tonation and Breathing Techniques (TBT): consist of a combination of organic inhalation and controlled exhalation with tonation. This will be guided by a trained facilitator, and the entire exercise will take 20 minutes. This will include guided relaxed breathing, mindful breathing, patterned tonation, nasal tonation, and pursed lip tonation.
Music Driven Vocal ExercisesBehavioural
Also called MDVE
Music Driven Vocal Exercises (MDVE): A Music Therapy procedure will be implemented by a trained facilitator, utilizing an accompanying instrument (ie, guitar or Autoharp) and moving stepwise up and down within a scale of 8 whole steps. The total length of the procedure is 20-25 minutes. This will include vocal exercises, and melodic exercises alternating with speaking,
Silent BreathingBehavioural
Patient will sit in a quiet room and focus on silent breathing x 20 min.
| Study group | Role | What they receive |
|---|---|---|
| Silent Breathing / Tonation Breathing Techniques (TBT) | Experimental | Twice a week during the patient's 8 weeks of pulmonary rehabilitation:
1. For first 4 weeks, twice a week - 20 min of silent quiet breathing while sitting.
2. Next 4 weeks, twice a week - 20 min of TBT guided by a facilitator virtually Receives: Behavioral: Tonation Breathing Techniques; Behavioral: Silent Breathing |
| Silent Breathing / Music Driven Vocal Exercises (MDVE) | Experimental | Twice a week during the patient's 8 weeks of pulmonary rehabilitation:
1. For first 4 weeks, twice a week - 20 min of silent quiet breathing while sitting.
2. Next 4 weeks, twice a week - 20 min of MDVE guided by a facilitator in-person Receives: Behavioral: Music Driven Vocal Exercises; Behavioral: Silent Breathing |
| Tonation Breathing Techniques (TBT) / Silent Breathing | Experimental | Twice a week during the patient's 8 weeks of pulmonary rehabilitation:
1. For first 4 weeks, twice a week - 20 min of TBT guided by a facilitator virtually
2. Next 4 weeks, twice a week - 20 min of silent quiet breathing while sitting. Receives: Behavioral: Tonation Breathing Techniques; Behavioral: Silent Breathing |
| Music Driven Vocal Exercises (MDVE) / Silent Breathing | Experimental | Twice a week during the patient's 8 weeks of pulmonary rehabilitation:
1. For first 4 weeks, twice a week - 20 min of MDVE guided by a facilitator in-person
2. Next 4 weeks, twice a week - 20 min of silent quiet breathing while sitting. Receives: Behavioral: Music Driven Vocal Exercises; Behavioral: Silent Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Borg dyspnea score
subjective score of dyspnea
Measured: 8 weeks
Secondary outcomes (7)
FEV1
forced expiratory volume in 1 second
Measured: 4 and 8 weeks
Borg dyspnea score
subjective score of dyspnea
Measured: 4 weeks
Breath hold
time in seconds participant can hold breath
Measured: 4 weeks, 8 weeks
quality of life (QOL)
questionnaire on quality of life
Measured: 4 weeks, 8 weeks
forced vital capacity (FVC)
forced vital capacity
Measured: 4 weeks, 8 weeks
peak flow
peak flow
Measured: 4 weeks, 8 weeks
negative inspiratory force (NIF)
negative inspiratory force
Measured: 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start7 Sep 2022
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Why it stopped: Change in location of Pulmonary Rehab at our institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial. Randomization for each subject occurs twice. First: One of two types of intervention. Second: Sequence for intervention and normal breathing sessions.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vidya Krishnan, MetroHealth Medical Center
- Investigators
- Vidya Krishnan, MD, MHS, Principal investigator, Case Western Reserve University, MetroHealth Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621967
- Sponsor's protocol ID
- STUDY00000152
- Status last verified
- Jun 2023
- First submitted
- 16 Sep 2022
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ostermann T, Schmid W. Music therapy in the treatment of multiple sclerosis: a comprehensive literature review. Expert Rev Neurother. 2006 Apr;6(4):469-77. doi: 10.1586/14737175.6.4.469.
PubMed 16623646Garcia-Casares N, Martin-Colom JE, Garcia-Arnes JA. Music Therapy in Parkinson's Disease. J Am Med Dir Assoc. 2018 Dec;19(12):1054-1062. doi: 10.1016/j.jamda.2018.09.025.
PubMed 30471799Canga B, Azoulay R, Raskin J, Loewy J. AIR: Advances in Respiration - Music therapy in the treatment of chronic pulmonary disease. Respir Med. 2015 Dec;109(12):1532-9. doi: 10.1016/j.rmed.2015.10.001. Epub 2015 Oct 19.
PubMed 26522499Mathis DR. Melodic sculpturing: the art and science of singing. Bloomington, IN: AuthorHouse, 2009
Price, Kate. The effects of vocal function exercises on the lung function of trained female singers: a pilot investigation. Diss. Victoria University, 2003.
McNamara RJ, Epsley C, Coren E, McKeough ZJ. Singing for adults with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2017 Dec 19;12(12):CD012296. doi: 10.1002/14651858.CD012296.pub2.
PubMed 29253921DRAPER MH, LADEFOGED P, WHITTERIDGE D. Respiratory muscles in speech. J Speech Hear Res. 1959 Mar;2(1):16-27. doi: 10.1044/jshr.0201.16. No abstract available.
PubMed 13655288Bouhuys A, Proctor DF, Mead J. Kinetic aspects of singing. J Appl Physiol. 1966 Mar;21(2):483-96. doi: 10.1152/jappl.1966.21.2.483. No abstract available.
PubMed 5934452Leanderson, R.; Sundberg, J. (1988). Breathing for singing. , 2(1), 2-12. doi:10.1016/S0892-1997(88)80051-1
Leanderson R, Sundberg J, von Euler C. Role of diaphragmatic activity during singing: a study of transdiaphragmatic pressures. J Appl Physiol (1985). 1987 Jan;62(1):259-70. doi: 10.1152/jappl.1987.62.1.259.
PubMed 3558185Huang J, Yuan X, Zhang N, Qiu H, Chen X. Music Therapy in Adults With COPD. Respir Care. 2021 Mar;66(3):501-509. doi: 10.4187/respcare.07489. Epub 2020 Nov 3.
PubMed 33144384Sliwka A, Nowobilski R, Polczyk R, Nizankowska-Mogilnicka E, Szczeklik A. Mild asthmatics benefit from music therapy. J Asthma. 2012 May;49(4):401-8. doi: 10.3109/02770903.2012.663031. Epub 2012 Mar 7.
PubMed 22397390Morrison, Ian, and S. M. Clift.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT05621967
- Acronym / sponsor ID
- STUDY00000152
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in location of Pulmonary Rehab at our institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 18 Nov 2022 (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.
To investigate Phonation therapy to improve symptoms and lung physiology in patients referred for pulmonary rehabilitation. The study design will be a randomized controlled trial. The primary outcome is improvement in patient symptoms (Borg dyspnea score). Secondary outcomes are improvement in time of breath hold, forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), negative inspiratory force (NIF) and improvement in quality of life. The investigators will be investigating tonation breathing techniques (TBT) exercises and music-driven vocal exercises (MDVE). The study population would be patients who are referred to pulmonary rehabilitation (PR) for symptomatic chronic lung disease. The calculated sample size for the study would be 16 patients and the duration of the study would be 8 weeks. The study would be performed after the participant's pulmonary rehabilitation session.
Detailed description
Patients who are referred for pulmonary rehabilitation for chronic lung disease and/or post-COVID19 therapy, and who have had pulmonary function testing already will be approached. Pulmonary rehabilitation is an 8-week program (meeting 3 times per week for the 8 weeks). Pulmonary rehabilitation (PR) is the standard of care for patients with chronic lung diseases and or post-COVID-19 therapy. Eligible study participants will be called prior to their introductory PR session to explain the research project, and those who are interested will be given full information and offered time to ask questions. The investigators find this necessary for logistics, given many of the PR patients rely on scheduled transportation to/from PR and this will allow those who are interested in obtaining more information and to consent to the study to arrange for appropriate transportation. Informed consent will be done in person on an individual basis at their introductory PR session, with 1:1 discussion with the study staff and the patient.
As this is a pilot study to determine feasibility, and preliminary data (as no data are currently available for this patient population), the investigators propose 16 participants in total, 4 in each arm of the study. Randomization will occur by random number generator (1-4 for each arm proposed).
Once informed consent is obtained, patients will be randomized to 4 arms of the study. Randomization will be performed using a random number generator.
- Comparing tonation breathing technique (TBT) to normal breathing:
- Of the 8 weeks of PR, first 4 weeks will be sessions of normal breathing exercises for 20 minutes, then subsequent 4 weeks will be with TBT intervention for 20 minutes.
- Of the 8 weeks of PR, the first 4 weeks will be with TBT intervention for 20 minutes, then the next 4 weeks will be of sessions of normal breathing exercises for 20 minutes.
- Comparing MDVE to normal breathing:
- Of the 8 weeks of PR, the first 4 weeks will be sessions of normal breathing exercises for 20 minutes, then the subsequent 4 weeks will be with Music Driven Vocal Exercises (MDVE) intervention for 20 minutes.
- Of the 8 weeks of PR, the first 4 weeks will be with MDVE intervention for 20 minutes, then the next 4 weeks will be of sessions of normal breathing exercises for 20 minutes.
These interventions would be performed after the usual PR time when patients would be normally discharged home. Therefore, no additional monitoring is expected.
Pulmonary function testing is standard for all patients who receive PR - testing before and after PR is routine clinical course. The investigators propose an additional pulmonary function test (PFT) study at 4 weeks, as part of the research protocol (covered by the Department of Medicine funding)
In summary, the interventions for research purposes will include:
- 20-minute sessions after PR for intervention (TBT or MDVE) or normal breathing for twice a week for the 8 weeks they are participating in PR.
- PFT at end of week 4
Proposed subjective outcomes are routinely asked of PR patients, but will be collected at baseline, at 4 weeks (mid-way), and at 8 weeks (end) of PR. Proposed objective outcomes:
- For FEV1, FVC - these are routinely collected at baseline and at end of PR. The investigators propose an additional PFT study at 4 weeks, covered by the DOM Faculty Development Fund.
- For peak flow and NIF - these are procedures that ask for patients to breathe maximally for inspiration and expiration. They are not routine measures collected but are routine bedside measurements for pulmonary patients that can be collected for any person without any additional risk or cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized control trial. Randomization for each subject occurs twice. First: One of two types of intervention. Second: Sequence for intervention and normal breathing sessions.
| Arm | Type | Receives |
|---|---|---|
| Silent Breathing / Tonation Breathing Techniques (TBT) | Experimental | Behavioral: Tonation Breathing Techniques, Behavioral: Silent BreathingTwice a week during the patient's 8 weeks of pulmonary rehabilitation: 1. For first 4 weeks, twice a week - 20 min of silent quiet breathing while sitting. 2. Next 4 weeks, twice a week - 20 min of TBT guided by a facilitator virtually |
| Silent Breathing / Music Driven Vocal Exercises (MDVE) | Experimental | Behavioral: Music Driven Vocal Exercises, Behavioral: Silent BreathingTwice a week during the patient's 8 weeks of pulmonary rehabilitation: 1. For first 4 weeks, twice a week - 20 min of silent quiet breathing while sitting. 2. Next 4 weeks, twice a week - 20 min of MDVE guided by a facilitator in-person |
| Tonation Breathing Techniques (TBT) / Silent Breathing | Experimental | Behavioral: Tonation Breathing Techniques, Behavioral: Silent BreathingTwice a week during the patient's 8 weeks of pulmonary rehabilitation: 1. For first 4 weeks, twice a week - 20 min of TBT guided by a facilitator virtually 2. Next 4 weeks, twice a week - 20 min of silent quiet breathing while sitting. |
| Music Driven Vocal Exercises (MDVE) / Silent Breathing | Experimental | Behavioral: Music Driven Vocal Exercises, Behavioral: Silent BreathingTwice a week during the patient's 8 weeks of pulmonary rehabilitation: 1. For first 4 weeks, twice a week - 20 min of MDVE guided by a facilitator in-person 2. Next 4 weeks, twice a week - 20 min of silent quiet breathing while sitting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years and older
- English-speaking and reading patient
- Able to consent for study
- Referred for pulmonary rehabilitation for chronic lung disease (including long COVID19 syndrome, COPD, ILD, PH)
- Baseline Borg dyspnea score as moderate (score 3) or higher.
Key exclusion criteria (1 listed)
- Cannot commit to staying an extra 30 min after Pulmonary Rehabilitation sessions for the study.
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 |
|---|---|---|
| Tonation Breathing TechniquesAlso: TBTTonation and Breathing Techniques (TBT): consist of a combination of organic inhalation and controlled exhalation with tonation. This will be guided by a trained facilitator, and the entire exercise will take 20 minutes. This will include guided relaxed breathing, mindful breathing, patterned tonation, nasal tonation, and pursed lip tonation. | Behavioural | Silent Breathing / Tonation Breathing Techniques (TBT), Tonation Breathing Techniques (TBT) / Silent Breathing |
| Music Driven Vocal ExercisesAlso: MDVEMusic Driven Vocal Exercises (MDVE): A Music Therapy procedure will be implemented by a trained facilitator, utilizing an accompanying instrument (ie, guitar or Autoharp) and moving stepwise up and down within a scale of 8 whole steps. The total length of the procedure is 20-25 minutes. This will include vocal exercises, and melodic exercises alternating with speaking, | Behavioural | Music Driven Vocal Exercises (MDVE) / Silent Breathing, Silent Breathing / Music Driven Vocal Exercises (MDVE) |
| Silent BreathingPatient will sit in a quiet room and focus on silent breathing x 20 min. | Behavioural | Music Driven Vocal Exercises (MDVE) / Silent Breathing, Silent Breathing / Music Driven Vocal Exercises (MDVE), Silent Breathing / Tonation Breathing Techniques (TBT), Tonation Breathing Techniques (TBT) / Silent Breathing |
Primary outcome
Borg dyspnea score
Time frame: 8 weeks
subjective score of dyspnea
7 secondary outcomes
FEV1
Time frame: 4 and 8 weeks
Borg dyspnea score
Time frame: 4 weeks
Breath hold
Time frame: 4 weeks, 8 weeks
quality of life (QOL)
Time frame: 4 weeks, 8 weeks
forced vital capacity (FVC)
Time frame: 4 weeks, 8 weeks
peak flow
Time frame: 4 weeks, 8 weeks
negative inspiratory force (NIF)
Time frame: 4 weeks, 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Background: PubMed 16623646Ostermann T, Schmid W. Music therapy in the treatment of multiple sclerosis: a comprehensive literature review. Expert Rev Neurother. 2006 Apr;6(4):469-77. doi: 10.1586/14737175.6.4.469.
- Background: PubMed 30471799Garcia-Casares N, Martin-Colom JE, Garcia-Arnes JA. Music Therapy in Parkinson's Disease. J Am Med Dir Assoc. 2018 Dec;19(12):1054-1062. doi: 10.1016/j.jamda.2018.09.025.
- Background: PubMed 26522499Canga B, Azoulay R, Raskin J, Loewy J. AIR: Advances in Respiration - Music therapy in the treatment of chronic pulmonary disease. Respir Med. 2015 Dec;109(12):1532-9. doi: 10.1016/j.rmed.2015.10.001. Epub 2015 Oct 19.
- BackgroundMathis DR. Melodic sculpturing: the art and science of singing. Bloomington, IN: AuthorHouse, 2009
- BackgroundPrice, Kate. The effects of vocal function exercises on the lung function of trained female singers: a pilot investigation. Diss. Victoria University, 2003.
- Background: PubMed 29253921McNamara RJ, Epsley C, Coren E, McKeough ZJ. Singing for adults with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2017 Dec 19;12(12):CD012296. doi: 10.1002/14651858.CD012296.pub2.
- Background: PubMed 13655288DRAPER MH, LADEFOGED P, WHITTERIDGE D. Respiratory muscles in speech. J Speech Hear Res. 1959 Mar;2(1):16-27. doi: 10.1044/jshr.0201.16. No abstract available.
- Background: PubMed 5934452Bouhuys A, Proctor DF, Mead J. Kinetic aspects of singing. J Appl Physiol. 1966 Mar;21(2):483-96. doi: 10.1152/jappl.1966.21.2.483. No abstract available.
- BackgroundLeanderson, R.; Sundberg, J. (1988). Breathing for singing. , 2(1), 2-12. doi:10.1016/S0892-1997(88)80051-1
- Background: PubMed 3558185Leanderson R, Sundberg J, von Euler C. Role of diaphragmatic activity during singing: a study of transdiaphragmatic pressures. J Appl Physiol (1985). 1987 Jan;62(1):259-70. doi: 10.1152/jappl.1987.62.1.259.
- Background: PubMed 33144384Huang J, Yuan X, Zhang N, Qiu H, Chen X. Music Therapy in Adults With COPD. Respir Care. 2021 Mar;66(3):501-509. doi: 10.4187/respcare.07489. Epub 2020 Nov 3.
- Background: PubMed 22397390Sliwka A, Nowobilski R, Polczyk R, Nizankowska-Mogilnicka E, Szczeklik A. Mild asthmatics benefit from music therapy. J Asthma. 2012 May;49(4):401-8. doi: 10.3109/02770903.2012.663031. Epub 2012 Mar 7.
- 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.
Vidya Krishnan, MD, MHS principal investigator
Case Western Reserve University, MetroHealth Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonation Breathing Techniques, Music Driven Vocal Exercises and Silent Breathing in people with COVID-19, run by MetroHealth Medical Center at 1 site in United States.
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 6 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: withdrawn, as of the sponsor's last update on 23 Jun 2023. 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Borg dyspnea score (time frame: 8 weeks). 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 NCT05621967, which also lists 13 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 23 Jun 2023.