Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
Phase: NA
Conditions: COVID-19
Sponsor: MetroHealth Medical Center

 
 
 
 
Page 1 of 15 
Revised: 02/9/2022 
 
PROTOCOL TITLE: 
Phonation therapy to improve symptoms and lung physiology in patients referred for 
pulmonary rehabilitation. 
PRINCIPAL INVESTIGATOR: 
Name: Vidya Krishnan, MD MHS 
Department: Medicine 
Telephone Number: 216-778-4527 
Email Address: vkrishnan@metrohealth.org 
VERSION NUMBER/DATE: 
Version 1.  May 1, 2022 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* ............................................................................................................... 4 
3.0 
Background* ............................................................................................................. 4 
4.0 
Study Endpoints* ...................................................................................................... 4 
5.0 
Study Intervention/Investigational Agent ................................................................. 6 
6.0 
Procedures Involved* ............................................................................................... 8 
7.0 
Data and Specimen Banking* .................................................................................. 9 
8.0 
Sharing of Results with Subjects* .......................................................................... 10 
9.0 
Study Timelines* .................................................................................................... 10 
10.0 Inclusion and Exclusion Criteria* .......................................................................... 10 
11.0 Vulnerable Populations* ........................................................................................ 10 
12.0 Local Number of Subjects ...................................................................................... 11 
13.0 Recruitment Methods ............................................................................................. 11 
14.0 Withdrawal of Subjects* ........................................................................................ 11 
15.0 Risks to Subjects* ................................................................................................... 11 
16.0 Potential Benefits to Subjects* ............................................................................... 12 
17.0 Data Management* and Confidentiality ................................................................. 12 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 12 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 12 
20.0 Compensation for Research-Related Injury ........................................................... 12 

 
 
 
 
Page 2 of 15 
Revised: 02/9/2022 
 
21.0 Economic Burden to Subjects ................................................................................ 13 
22.0 Consent Process ...................................................................................................... 13 
23.0 Process to Document Consent in Writing .............................................................. 13 
24.0 Setting ..................................................................................................................... 13 
25.0 Resources Available ............................................................................................... 14 
26.0 Multi-Site Research* .............................................................................................. 15 
 
 
 

 
 
 
 
Page 3 of 15 
Revised: 02/9/2022 
 
1.0 
Study Summary 
 
Study Title 
Phonation therapy to improve symptoms and lung 
physiology in patients referred for pulmonary rehabilitation. 
Study Design 
Randomized Controlled Trial 
Primary Objective 
1) Improvement in patient symptoms (Borg dyspnea 
score)  
Secondary 
Objective(s) 
1) Improvement in time of breath hold.  
2) Improvement in lung physiology – FVC, FEV1, NIF 
3) Improvement in quality of life 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
1) Tonation Breathing Techniques (TBT) Exercises 
2) Music Driven Vocal Exercises (MDVE) 
IND/IDE #  
 
Study Population 
Patients who are referred to Pulmonary Rehabilitation for 
symptomatic chronic lung disease 
Sample Size 
16 
Study Duration for 
individual 
participants 
8-weeks 
Study Specific 
Abbreviations/ 
Definitions  
FVC – forced vital capacity; FEV1 – forced expiratory 
volume in 1 second; NIF – negative inspiratory force; PR-
Pulmonary Rehabilitation; TBT – Tonation Breathing 
Techniques; MDVE – Music Driven Vocal Exercises; PFT – 
pulmonary function testing 
 
 

 
 
 
 
Page 4 of 15 
Revised: 02/9/2022 
 
2.0 
Objectives* 
The objective of this study is to determine whether breathing and 
vocalization exercises improve dyspnea in patients who are referred for 
pulmonary rehabilitation (PR).  
The specific aims are to determine the following: 
1) Do breathing and vocalization exercises improve subjective pulmonary 
symptoms and objective pulmonary function in patients referred for 
PR, compared to no intervention? 
a. Specific outcomes include: subjective: Borg dyspnea score 
b. Specific outcomes include: objective: Forced expiratory 
volume in 1 second (FEV1), forced vital capacity (FVC), Peak 
Flow, Negative Inspiratory Force (NIF), peak flow 
2) Do breathing and vocalization exercises improve subjective pulmonary 
symptoms and objective pulmonary function, compared to calm 
normal breathing? 
a. Specific outcomes include: subjective: Borg dyspnea score 
b. Specific outcomes include: objective: FEV1, FVC, NIF, peak 
flow 
3) Is there a difference between two different proposed techniques of 
breathing and vocalization exercise techniques to improve subject 
pulmonary symptoms and objective pulmonary function? 
a. Specific outcomes include: subjective: Borg dyspnea score 
b. Specific outcomes include: objective: FEV1, FVC, NIF, peak 
flow 
 
Our hypotheses are that breathing and vocalization techniques are a) 
feasible; b) can improve subjective and objective pulmonary 
outcomes; c) there is no significant difference between the two 
proposed techniques of breathing and vocalization techniques.  
 
3.0 
Background* 
 
Music therapy has been successfully prescribed for various diseases such as anxiety, 
depression, neurological diseases such as epilepsy, Parkinson’s disease, and multiple 
sclerosis. 1,2 Music therapy and psycho-music therapy has also been beneficial in chronic 
lung disease such as chronic obstructive lung disease and has shown to improve 
symptoms of dyspnea and depression.3 Singing is based on respiratory physiology, it 
consists of four stages of breathing inhalation, suspension, controlled exhalation, and 

 
 
 
 
Page 5 of 15 
Revised: 02/9/2022 
 
recovery.4 The production of voice and phonation is a complex process and involves 
producing sound as air from the lower respiratory tract passes through the vocal cord this 
generates a functional connection between the lower respiratory tract and larynx 5. 
Singing is distinct from tidal breath, singing generates large lung volumes and therefore 
requires active exhalation compared to tidal breathing. 6,7 The diaphragm functions 
differently while singing compared to normal phonation and tidal breathing. During tidal 
breathing and phonation, the diaphragm is passive, whereas it is continuously contracting 
during singing. 7,8,9,10 
 
 
In the current literature benefit of music therapy in the treatment of chronic lung disease 
is unclear. A recent metanalysis conducted by Huang et al. showed an improvement in 
dyspnea and anxiety with the use of passive music(listening) along with mixed music 
(listening and singing) in COPD patients, The results were statistically significant 
although the study had a few limitations - methodology of study selection was not clearly 
defined;, the music was selected by the subjects; and the duration of follow up was short. 
11 In another study conducted in Poland in 2017 by Sliwka et al. evaluated the efficacy of 
pulmonary rehabilitation with music therapy in patient with mild asthma. A greater 
increase in mean FEV1/FVC, FEF(50), and FEF(75) was observed in music therapy 
group with pulmonary rehabilitation compared to pulmonary rehabilitation alone, 
although there was an overall increase in FEV1, FEV1/FVC, (FEF(25), FEF(50), and 
FEF(75) in both groups.12 Another large study conducted by Morrison et al. in 2013 
followed patients for a 10-month period, 106 subjects with COPD were enrolled into a 
weekly community singing along with breathing exercises. After 10 months the study 
showed significant improvement in FEV1% and FVC% along with subject reported 
improvement quality of life, there was no significant improvement in dyspnea. Despite a 
longer period of follow up, the authors reported limitation due to no control group.13 
Music therapy for respiratory health remains encouraging but music therapy is not 
routinely incorporated into pulmonary rehabilitation courses and the type of music 
therapy that is most effective remains indeterminate.  
 
The objectives of our study are to a) determine whether breathing and phonation 
exercises improve symptoms and lung function in patient with chronic lung disease 
referred to pulmonary rehabilitation and b) compare two approaches to music therapy 
(Tonation Breathing Technique (TBT) and Music Driven Vocal Exercises (MDVE)) for 
feasibility and efficacy in incorporating into pulmonary rehabilitation.   
 
We propose a pilot study to obtain preliminary data and assess feasibility of instituting 
music therapy into pulmonary rehabilitation.  Once we establish feasibility, we will 
propose a larger study to compare the two approaches to music therapy as well determine 
the long-term effects of music therapy added to pulmonary rehabilitation.   
.  
 
 References  

 
 
 
 
Page 6 of 15 
Revised: 02/9/2022 
 
 
 
1.Ostermann, Thomas; Schmid, Wolfgang (2006). Music therapy in the treatment of multiple 
sclerosis: a comprehensive literature review. Expert Review of Neurotherapeutics, 6(4), 469–477. 
doi:10.1586/14737175.6.4.469. 
 
2.García-Casares, Natalia; Martín-Colom, Julia Eva; García-Arnés, Juan Antonio (2018). Music 
Therapy in Parkinson's Disease. Journal of the American Medical Directors Association, 19(12), 
1054–1062. doi:10.1016/j.jamda.2018.09.025 
 
3.  Canga B, Azoulay R, Raskin J, et al. AIR: advances in respiration—music therapy in the 
treatment of chronic pulmonary disease. Respir Med. 2015;109:1532–1539 
 
4. Mathis DR. Melodic sculpturing: the art and science of singing. Bloomington, IN: AuthorHouse, 
2009 
 
5.  Price, Kate. The effects of vocal function exercises on the lung function of trained female 
singers: a pilot investigation. Diss. Victoria University, 2003. 
 
6. McNamara RJ, Epsley C, Coren E, McKeough ZJ. Singing for adults with chronic obstructive 
pulmonary disease. Cochrane Database of Systematic Reviews 2017, Issue 12. Art. No.: 
CD012296. DOI: 10.1002/14651858.CD012296.pub2. Accessed 19 May 2022. 
 
7. Draper M, Ladefoged P, Whitteridge D. Respiratory muscles in speech. J Speech Hear Res 
1959;2:16-27.  
 
8.Bouhuys A, Proctor D, Mead J. Kinetic aspects of singing. J Appl Physiol 1966;21:483-96,  
 
9. Leanderson, R.; Sundberg, J. (1988). Breathing for singing. , 2(1), 2–12. doi:10.1016/S0892-
1997(88)80051-1  
 
10.Leanderson R, Sundberg J. yon Euler C. The role of diaphragmatic activity during singing. A 
study of transdiaphragmatic pressures. J Appl Physiol 1987;62:259-70.  
 
11. Huang 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. PMID: 33144384. 
 
12. Sliwka 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. PMID: 22397390. 
 
13.Morrison, Ian, and S. M. Clift. "A UK feasibility study on the value of singing for people with 
Chronic Obstructive Pulmonary Disease (COPD) September 2011 to June 2012Ian Morrison." 
European Journal of Public Health 23.suppl_1 (2013). 
 
4.0 
Study Endpoints* 
1) Specific outcomes include: subjective: Borg dyspnea score 
2) Specific outcomes include: objective: FEV1, FVC, NIF, peak flows 
(all obtained from spirometry) 

 
 
 
 
Page 7 of 15 
Revised: 02/9/2022 
 
No specific safety outcomes are proposed, as no significant risks are 
associated with the proposed intervention.   
5.0 
Study Intervention/Investigational Agent 
 
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. 
1. Guided relaxed breathing: the subjects are asked to be conscious of any tensing of 
muscles all along the respiratory system and guided to relax them. 
2. Mindful breathing: the subjects are next asked to observe their breathing and its 
effects at different points in their body. 
3. Patterned tonation: the subjects are asked to hold a tone at any frequency comfortable 
to them, followed by a slightly lower frequency, a slightly higher frequency and then 
again at their original frequency. 
4. Nasal tonation:  The subjects are asked to close one nostril, inhale gently through the 
other nostril, followed by slow exhalation with tonation. This is done for 5 
repetitions. The process is repeated for the other nostril. 
5. Pursed lip tonation: The subjects are asked to inhale gently through their nostrils, 
purse their lips (in the motion of sucking a straw or blowing a balloon) and then 
exhale through their mouth with tonation. This is done for 5 repetitions. 
 
Music Driven Vocal Exercises (MDVE):  The following 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. 
1. Subjects will be taught the following vocal exercises that they will sing 10x each in 
the following order 
a. Ha-Ha-Ha  (Do-Re-Do) 
b. Hee-Hee-Hee-Hee-Hee  (Do-Re-Do-Ti-Do) 
c. Hoo-oo-oo-oo-oo-oo-oo-oo-oo  (Do Re Mi Fa Sol Fa Mi Re Do) 
 
2. Subjects will be taught the following melodic exercises that they will sing 10X and 
then speak 5X.  The first session will consist of the first 3 phrases, each subsequent 
session will add the next phrase on the list. 
a. Whose Hands Hold Hearts Harps and Hangers (Do-Re-Do-Fa-Re-Do-Ti-Do) 
b. Peter Piper Picked a Peck of Pickled Peppers (Do-Re-Do-Ti-Do-Re-Do-Re-Mi-
Re-Do-Do) 
c. Awkward Alice Ate Apples At an Airport (Do-Mi-Sol-Mi-Mi-Fa-Mi-Re-Mi-Mi-
Do) 
d. Granny Grills Grits for Gorillas (Do-La-Ti-Do-Do-Re-Mi-Do) 
e. Zealous Zebras in Zoot Suits (Do-Re-Mi-Re-Fa-Do-Do) 

 
 
 
 
Page 8 of 15 
Revised: 02/9/2022 
 
f. William and Gabby Grow White Grapes in Gorgeous Wintry Gardens (Do-Mi-
Re-La-La-Ti-Re-Do-Ti-Do-Re-Re-Do-Mi-Do) 
 
 
6.0 
Procedures Involved* 
Patients who are referred for pulmonary rehabilitation for chronic lung disease 
and/or post-COVID19 therapy, 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 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 offer time to ask questions.  We find this necessary for logistics, given many 
of our 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), we 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. 
1)   Comparing TBT to normal breathing: 
a. 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. 
b. Of the 8 weeks of PR, first 4 weeks will be with TBT intervention for 
20 minutes, then next 4 weeks will be of sessions of normal breathing 
exercises for 20 minutes. 
2) Comparing MDVE to normal breathing: 
a. 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 WT intervention for 20 minutes. 
b. Of the 8 weeks of PR, first 4 weeks will be with MDVE intervention 
for 20 minutes, then next 4 weeks will be of sessions of normal 
breathing exercises for 20 minutes. 

 
 
 
 
Page 9 of 15 
Revised: 02/9/2022 
 
These interventions would be performed after 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.  We propose an additional 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: 
1) 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. 
2) 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: 
1) For FEV1, FVC – these are routinely collected at baseline and at end of PR.  
We propose an additional PFT study at 4 weeks, covered by the DOM Faculty 
Development Fund.   
2) For peak flow and NIF – these are procedures that ask for patient 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.   
 
Data will be obtained as following: 
1)  Routinely obtained information will be collected from EPIC into a 
REDCap database.  This includes: 
a. Patient demographics – name, MRN, DOB, sex, gender, race, 
ethnicity, height, weight, BMI, 
b. Pulmonary history: reason for PR referral (routine collection); date of 
symptom onset; date of diagnosis of lung pathology; prior PFT 
findings – FEV1, FVC, peak flow, NIF.   
c. PR questionnaire info: Borg dyspnea score at baseline and each visit 
(routine collection) 
There are no plans for long-term follow-up. 
7.0 
Data and Specimen Banking* 
Data will be obtained as following: 

 
 
 
 
Page 10 of 15 
Revised: 02/9/2022 
 
Routinely obtained information will be collected from EPIC into a REDCap database.  
This includes: 
7.1 
Patient demographics – name, MRN, DOB, sex, gender, race, 
ethnicity, height, weight, BMI, 
7.2 
Pulmonary history: reason for PR referral (routine collection); date 
of symptom onset; date of diagnosis of lung pathology; prior PFT findings 
– FEV1, FVC, peak flow, NIF.   
7.3 
PR questionnaire info: Borg dyspnea score at baseline and each 
visit (routine collection) 
 
Informed consent forms will be signed and scanned into patient charts (in the media 
manager).  Physical consent forms will be retained in the PI’s office, in a locked cabinet 
in the locked room for the required amount of time.  
 
8.0 
Sharing of Results with Subjects* 
As this is a pilot project, no significant findings are expected from the study.  For an 
individual, the results of repeat PFT testing done for research will be available to the 
patient in EPIC through MyChart.   
 
9.0 
Study Timelines* 
An individual participants time in the study will be approximately 8 weeks.   
Time 0 – Informed Consent signed.   
Weeks 1-8 – normal Pulmonary Rehabilitation 3 times a week, with phonation 
intervention (TBT or MDVE) or silent breathing time. 
On last session of week 4 and week 8:  PFT’s, NIF, VC, peak flows will be 
measured.  Borg dyspnea scale will be collected.   
We hope to collect 16 participants for this study by November 2022, and have 
primary analysis completed by December 2022 for submission to American 
Thoracic Society 2023 presentation.  
10.0 Inclusion and Exclusion Criteria* 
Inclusion: 
1) Age 18 years and older 
2) English-speaking and reading patient 
3) Able to consent for study 
4) Referred for pulmonary rehabilitation for chronic lung disease (including long 
COVID19 syndrome, COPD, ILD, PH) 
5) Baseline Borg dyspnea score as moderate (score 3) or higher.   
6) Has baseline pulmonary function testing available in electronic medical record. 
 
Exclusion: 

 
 
 
 
Page 11 of 15 
Revised: 02/9/2022 
 
1) Cannot commit to staying an extra 30 min after Pulmonary Rehabilitation 
sessions for the study.   
 
11.0 Vulnerable Populations* 
This study does not include vulnerable populations.   
 
12.0 Local Number of Subjects 
Plan to recruit 16 participants for this study.   
Anticipate needing to screen 40 participants for this study.   
 
13.0 Recruitment Methods 
Patients who are scheduled to start Pulmonary Rehabilitation will be called by 
one of the consenting investigators.  The study will be described and any 
questions will be answered.  The consent form will be sent to the patient to 
review in full.  On the first day of Pulmonary Rehabilitation (PR), the patient 
will meet with a study investigator in a private room, and any further questions 
will be answered, and if patient is agreeable, will sign the consent form.   
Source of participants will be all referred for Pulmonary Rehabilitation (patients 
are within the practice of the PI).  
We will request partial HIPAA waiver to access patients’ charts who are 
scheduled for Pulmonary Rehabilitation and assess inclusion and exclusion 
criteria and study eligibility.  This will allow us to call patients and talk to them 
about their participation in this study, and answer questions prior to obtaining 
full informed consent.   
A payment of $10 by MetroHealth gift card  will be given to the patient upon 
completion of 4 weeks of the research study / PR.  An additional $20 will be 
added to the participant’s MetroHealth gift card  on the last day of PR after 
completion of the study surveys and testing. This will be funded through the 
Pulmonary/CC Fellow MH Foundation fund.   
14.0 Withdrawal of Subjects* 
Participants of the study who miss 3 sessions of study intervention in the first 4 
weeks of the PR will be notified that their enrollment in the study is at risk.  
Participants who miss 4 sessions will be withdrawn from the study.  They will be 
given written notification that their enrollment in the study is cancelled, and this 
will be put in the patient’s electronic medical record, in the media manager.   
Subjects will not have sufficient data collected to analyze, so the data will not be 
analyzed, and the participant will not count towards the expected enrollment 
number.   
15.0 Risks to Subjects* 

 
 
 
 
Page 12 of 15 
Revised: 02/9/2022 
 
There are no foreseeable risks or hazards to the proposed interventions.  There 
may be a discomfort in the phonation exercises, if persons have not done this 
before, but the participant is only asked to do what is tolerated.  There is an 
inconvenience to the patient that they have to stay an extra 30 min after their 
usual PR session for the study intervention.  They will be compensated $30 total 
($10 at the beginning of the study, $20 at the end of the study).   
 
There are risks of loss of confidentiality in this study, as in any other study that 
identifies participants.  No sensitive data will be collected, and the data will be 
stored in the secure REDCap system.  Only de-identified data will be downloaded 
from REDCap for analysis purposes.  This de-identified data will be stored in the 
PI’s secure G: drive folder for research.   
 
16.0 Potential Benefits to Subjects* 
Individual participants may experience improved symptoms of dyspnea and pulmonary 
function.  They may also enjoy the interaction with a trained music therapist.   
 
Overall, the data from this study would inform a larger study that could show a novel 
way of improving pulmonary rehabilitation, and innovative ways to improve dyspnea 
symptoms and pulmonary function in patients with chronic respiratory illness.   
 
17.0 Data Management* and Confidentiality 
Descriptive analyses will be performed first on each of 4 categories.   Chi-squared tests 
and ANOVA testing will be performed, although with low sample size, significance is 
not expected in these analyses.  No power analysis will be performed, as this will be a 
pilot study.   
 
Baseline data, including patient demographics, baseline pulmonary function test results, 
baseline Borg dyspnea score will be saved into a REDCap database.  This database will 
only be accessible by study investigators. De-identified database will be downloaded for 
analysis, and this will be stored on the PI’s G: drive research folder. Study records will be 
stored according to the MHS Record Retention Policy VII-4, which is minimum 4 years 
after study completion.   
 
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
N/A 
19.0 Provisions to Protect the Privacy Interests of Subjects 
Consent will be obtained from participants.  Data will be collected into a secure 
REDCap database, that will be accessible only by study investigators.   

 
 
 
 
Page 13 of 15 
Revised: 02/9/2022 
 
We have one consultant working with us, Dr. Uma Ranjan, CEO of Clisonics.  
She developed the TBT therapy approach.  She will not have access to the 
REDCap database.  Individual-level data will not be shared with her – only the 
final summaries of the data.  No data will leave MetroHealth’s campus/intranet.   
20.0 Compensation for Research-Related Injury 
We do not anticipate any research-related injuries.  This proposed project is a minimal 
risk study.    No compensation will be provided  
 
21.0 Economic Burden to Subjects 
No costs are anticipated for the patients.  The study intervention would require an 
additional 25-30 min of time to be spent at Pulmonary Rehabilitation, which they 
would already be scheduled for.  Pulmonary function test for research purpose 
will be funded by grants secured by the investigators. 
 
22.0 Consent Process 
Consent will be obtained by one of the designated study investigators.  Patients 
eligible for the study will be identified through EPIC review, and the patient will 
be called by a designated study investigator to introduce the idea of the study and 
determine if the patient is interested.  If so, then the informed consent form will 
be mailed/emailed to the patient.  There will be at least 1 week between patient 
receiving the consent form and the patient’s first day of PR.   
On the first day of PR, the patient will be met by a designated study investigator 
to give informed consent.  A private room in the PR area will be used to discuss 
the study.  All patient questions will be answered at this time.  If patient is 
agreeable and understands the study and expectations, they will sign the consent.  
The patient will be given a $10 MetroHealth gift card  at that time.   
Upon completion of PR and participation in the study, the participant will receive another 
$20 uploaded to their existing MetroHealth gift card  on the last day of PR.   
 
23.0 Process to Document Consent in Writing 
Consent forms will be signed by participants.  They will be given a copy of the ICF.  The 
signed form will be scanned into Media Manager of the patient’s electronic medical 
record.  The physical copy will be stored in the PI’s office, in a locked cabinet. The paper 
forms will be kept for 4 years after the study completion.  Completed consent will be 
noted in the REDCap database.   
 
24.0 Setting 
The study will primarily be conducted in the Pulmonary Rehabilitation center, in 
Hamann 3rd floor H&V clinic on MetroHealth main campus.  There are rooms 

 
 
 
 
Page 14 of 15 
Revised: 02/9/2022 
 
that are secure and private in the area that can be used for recruitment and consent 
process.  
Data analysis will be conducted on MH computers on-site, in the PI’s office in 
BG3-38.  Data will be saved on secure intranet folders, and only available to the 
research investigators.  Signed paper consent forms will be the only paperwork 
for this study, and will be stored in a locked cabinet in a locked office of BG3-38  
(PI’s office).   
 
No community advisory board will be involved in this study.   
No research will be conducted outside the organization. 
 
25.0 Resources Available 
Patients are enrolled in pulmonary rehabilitation each week – approximately 16 new 
patients per month.  They are enrolled for an 8-week period.  Based on prior research 
studies on the same patient population, we anticipate about 50% enrollment.   This is a 
pilot project proposal, so we propose to recruit 10 subjects initially. 
 
PI proposed about 2.5% of FTE to the research study.  Fellows will have dedicated 
research time to enroll subjects and collect data.  Music therapy consultants will spend 
about 30 min/patient session (2 sessions per week x 8 weeks x 16 participants = 128 
hours) on the study.  They have graciously offered to provide the music therapy 
intervention pro bono for this pilot study.  Baseline and post-rehab PFT’s are clinically 
routine.  The research spirometry proposed at 4 weeks requires funding.  Investigators 
have been awarded a DOM Faculty Development Grant to support this expense ($150 per 
spirometry x 16 participants = $2400). Additional funding is also provided by Arts in 
Health operating budget. Patient incentive MetroHealth gift cards will be funded by the 
MH Pulmonary/Critical Care Fellows Fund through the MH Foundation. 
 
The study will be conducted in the Pulmonary Rehabilitation center, in Hamann 3rd floor 
in the H&V clinic.  There are dedicated rooms for education that will be used for the 
intervention sessions. No additional equipment will be needed. 
 
No medical or psychological support is anticipated as needed during these sessions.  
There is always a physician-on-call for pulmonary rehabilitation while patients are 
present.  If the physician-on-call is notified about a patient who is enrolled in the current 
study and develops any complications during the intervention, the physician-on-call will 
notify the PI.   
 
All study investigators and persons assisting with the research will be given the full study 
protocol.  We will have regular meetings to determine study progress, review study 
procedures, and address any issues related to the proposed study.   
 

 
 
 
 
Page 15 of 15 
Revised: 02/9/2022 
 
 
26.0 Multi-Site Research* 
N/A