Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders
Phase: NA
Conditions: Voice and Resonance Disorders, Vocal Fold Polyp, Vocal Cord Cyst, Vocal Cord Polyp, Atrophy of Vocal Cord
Sponsor: Jacqueline Gartner-Schmidt

Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorder 
NCT03410797 
February 11, 2020 

9/24/2020 
Print: STUDY19010151 - Efficacy of a variably-occluded facemask in voice therapy 
Pittl 
I Pitt Protocol 
I Review Online 
Date: Thursday, September 24, 2020 10:09:02 AM 
View: Pitt SF: Basic Study Information 8.2 
Basic Study Information 
* Title of study:
Efficacy of a variably-occluded facemask in voice therapy 
* Short title:
Efficacy of a variably-occluded facemask in voice therapy 
* Brief description:
To determine initial efficacy of a semi-occluded facemask on voice outcomes in 
patients with muscle tension dysphonia (MTD), lesions, and atrophy. We 
hypothesize that patients will demonstrate an improvement in acoustic, aerodynamic 
outcomes, and voice handicap index scores following therapy. 
* What kind of study is this?
Single-site study 
* Will an external IRB act as the IRB of record for this study?
OYes eNo
* Local principal investigator:
Jackie Gartner-Schmidt 
* Is this your first submission, as Pl, to the Pitt IRB?
0Yes O No
. * Does the local principal investigator have a financial interest related to this 
research? 
QYes eNo 
Attach the protocol: 
11 Sponsor/Multicenter/lnvestigator-initiated protocol 
" Coordinating Center supplement 
11 Emergency Use ConsenU Protocol/ FDA Form 3926 
11 Exempt Application form 
Document Category Date Modified 
Document History 
There are no items to display 
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Funding Sources 
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View: Pitt SF: Funding Sources (not integrated with Grants) 
. * Indicate all sources of support: 
Internal funding 
* Provide the source of your Internal funding:
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View: Pitt SF: Study Team Members 
Study Team Members 
* Identify each person involved in the design, conduct, or reporting of the
research (includes Pl):
Involved 
Name 
Roles 
Department/School Affiliation in 
Qualifications
Consent 
Jackie 
p . 
. 
I 
U of Pgh I School Pitt
Gartner-
rmc
'f.a 
t 
of Medicine I 
yes 
Schmidt lnves ,ga or Otolaryngology 
faculty
p . 
U of Pgh I School 
Christine s'
ary 
of Medicine I 
Harrison cioinator l=if ology 
Pitt staff no
Dr. Gartner-Schmidt, 
PhD is the Co-director of
the UPMC Voice Center 
and Professor, 
Department of 
Otolaryngology at the
Univerity of Pittsburgh
Scho .. ·l view]ill] 
External team member information: (Address all study team members in item 
1. above and leave this section blank)
Name 
Description 
There are no items to display 
Have you, Jackie Gartner-Schmidt, verified that all members of the research
team have the appropriate expertise, credentials, training, and if applicable, 
child clearances and/or hospital privileges to perform those research 
procedures that are their responsibility as outlined in the IRB application? 
*
8Yes QNo
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View: Pitt SF: Study Scope 8.1 
Study Scope 
Check all that apply 
"' * Will this study actively recruit any of the following populations? 
D Adults with impaired decision-making capacity 
D Children (under the applicable law of the jurisdiction in which the research will
be conducted (<18 years for PA)) 
0 Children who are Wards of the State 
D Employees of the University of Pittsburgh/UPMC 
0 Medical Students of University of Pittsburgh as primary research group 
0 Students of the University of Pittsburgh 
D Neonates of uncertain viability 
0 Non-viable neonates 
0 Non-English speakers 
0 Nursing home patients in the state of Pennsylvania 
0 Pregnant women 
0 Prisoners 
 N/A 
* Will any Waivers be requested?
0 Waiver/Alteration of Consent
0 Waiver to Document Consent
0 Waiver/Alteration of HIPAA
0 Exception from consent for emergency research
 N/A
* Will this study involve any of the following?
0 Specimens
0 Honest Broker to provide data/specimens
D Return of Results to Subjects or Others
0 Fetal tissue
 N/A
* Will Protected Health Information be collected?
0 Pitt medical records
 UPMC medical records
0 Other Institutions' medical records
0 NIA 
* Other Requests?
0 Deception (if not Exempt, also requires Waiver/Alteration of Consent)
0 Emergency Use / Single Patient Expanded Access (using FDA Form 3926)
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0 Placebo Arm 
0 Withdraw from usual care 
{ N/A 
* Determining Scientific Review:
Department Scientific Review (DOD requires departmental review)
* Choose the appropriate organization to conduct the scientific review:
U of Pgh I School of Medicine I Otolaryngology
* Has this study (or substantially similar study) been previously disapproved
by the Pitt IRB or, to your knowledge, by any other IRB?
0Yes O No 
Review the HRPO policy, if participating in research at the VA Pittsburgh Healthcare 
System or using funding from the VA 
* Does the study use an approved drug or biologic, use an unapproved drug
or biologic, or use a food or dietary supplement to prevent, diagnose, cure,
treat, or mitigate a disease or condition?
QYes 0No 
* Does the study evaluate the safety or effectiveness of a device (includes in­
vitro laboratory assays)?
8Yes QNo 
* Is this application being submitted to convert an approved study from
OSIRIS to PittPRO? (Tip Sheet)
OYes QNo 
Download the OSIRIS Transition Continuing Review form. complete and upload below. If 
you need to attach any additional documents (e.g., data and safety monitoring reports), 
upload in the Local Supporting Documents page and note the Renewal on the form. 
Exempt submissions in OSIRIS also need to move into PittPRO if they remain ongoing. 
These will not be considered transitions but new studies. Therefore, Study Scope #10 
will be answered as "No." Once the new exempt determination has been issued, the 
OSIRIS application can be closed. Any exempt submission remaining in OSIRIS by the 
end of August 2020 will be closed by our office. Please use the "Add Comment" to 
provide the OSIRIS study number. 
OSIRIS Transition Continuing Review form: 
OSIRIS Renewal and Conversion(0.01) 
* OSIRIS ID
PRO17100675
, * Does your research protocol involve the evaluation or use of procedures 
that emit ionizing radiation and, after reviewing this HUSC guidance, does your 
research protocol require HUSC review? (If yes, upload the HUSC form in the 
Local Supporting Documents section). If you are unsure of review 
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requirement, select yes. 
OYes •No 
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View: Pitt SF: Research Sites 
Research Sites 
Choose all sites that apply: 
UPMC 
* Select the UPMC sites where research will be conducted:
East
Mercy
Passavant
Other UPMC Site- Specify below:
List the Other UPMC sites: 
UPMC Bethel Park 
Describe the availability of resources and the adequacy of the facilities to 
conduct this study: 
* The UPMC Voice Center has the appropriate space and personnel to study the
population indicated in this protocol. The subjects are individuals that are typically 
seen and evaluated by the clinicians involved in this project. 
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View: Pitt SF: Devices
Devices 
. * List each device in the study that will be evaluated for safety or 
effectiveness: 
Device 
Purpose
This mask is being
used as an additional
aid in voice therapy.
Subjects are being
asked to speak into
the mask which is
thought to enhance
voice therapy
exercises. The semi­
occluded face mask
S 
. 
qualifies as a non-
e, d d significant risk device
View cc  e in that: 1. It is not an 
as 
implant; 2. It is not 
used in supporting or
sustaining human life;
3. It does not aid in
curing, mitigating, or
treating disease; 4. It
does not present a
potential for serious
risk to the health,
safety, or welfare of
the subject.
Type
Exempt from
IDE
requirements
Attachments
If applicable, identify each investigational device exemption (IDE) number: 
IDE Number
IDE Holder
Other Holder
There are no items to display
Attach files: (attachments may include justification of risk determination, FDA
correspondence and if the holder of the IDE is a University of Pittsburgh based,
sponsor-investigator, attach both the FDA acknowledgement letter and approval
letter)
Document Category Date Modified 
Document History
There are no items to display
* Describe your plan to manage devices so that they will be used only on
subjects and be used only by authorized investigators: 
Semi occluded facemasks will only be used by trained speech language
pathologists who are participating in this research. The customized grommets that
occlude the end of the mask were specifically made for this research study and are
not available elsewhere.
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View: Pitt SF: Local Site Documents 
Click Continue as this page was intentionally left blank. 
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View: Pitt SF: Recruitment Methods 
Recruitment Methods 
* Will you be recruiting individuals for participation in this study?
9Yes 0No
* Describe who will be recruiting individuals for participation for this study:
Study team members also involved in clinical care. 
* Select all methods to be used for recruitment:
Directly approaching potential subjects (in-person)
* Provide details on your recruitment methods:
Individuals will be identified during the course of usual clinical care of patients at the 
University of Pittsburgh Voice Center. As potential subjects are being clinically 
evaluated in the University of Pittsburgh Voice Center, they will encounter at least 
one member of the research team who will be able to determine eligibility through 
the clinical review of medical records associated with their visit. Once verification of 
eligibility is obtained, potential subjects will be approached by a member of the 
research team to review the informed consent document. Any and all questions will 
be addressed during this time. 
* Describe all compensation/incentives offered to participants and timing of
these offers: 
Participants will be paid $100 in total for completion of the 4 voice therapy sessions 
and follow-up session. The $100 payment will be made after the completion of the 5 
visits (4 therapy and 1 follow up). There will be no partial payment. Payment will be 
managed with a reloadable debit card. 
Participants will be paid when they present for the follow-up visit after completing 4 
voice therapy sessions. 
Recruitment materials: (attach all material to be seen or heard by subjects, 
including advertisements and scripts) 
Document Category Date Modified 
Document History 
There are no items to display 
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View: Pitt SF: Study Aims 
Study Aims 
* Describe the purpose, specific aims, or objectives and state the hypotheses
to be tested: 
To determine the efficacy of a semi-occluded mask in the treatment of patients with 
voice disorders 
To determine initial efficacy of a semi-occluded facemask on voice outcomes in 
patients with MTD, lesions, and atrophy. We hypothesize that patients will 
demonstrate an improvement in acoustic, aerodynamic outcomes, and voice 
handicap index scores following therapy. 
* Describe the relevant prior experience and gaps in current knowledge
including preliminary data. Provide for the scientific or scholarly background 
for, rationale for, and significance of the research based on existing literature 
and how it will add to existing knowledge: 
Current Semi Occluded Voice Therapy (SOVT) therapies limit the type of 
vocalizations that can be produced to single vowels, which does not promote 
learning of the healthy voice behavior in connected speech or generalization to 
conversation. However, recent preliminary results using a semi-occluded mask 
indicate that the use of certain mask port diameters may allow for natural speech 
production while increasing supraglottal pressure and impedance, and thereby result 
in elicitation of voice with increased efficiency. In addition, the use of a semi­
occluded mask provides the possibility for a better transition from phonating single 
phonemes in therapy to training the target therapy techniques in connected speech. 
A healthy voice is essential for communicative activities of daily living. 
Approximately 28 million workers in the U.S. experience daily voice problems, which 
can impair quality of life and work performance. People of all ages, genders, and 
social statuses suffer from voice problems.4 People with voice problems experience 
worse emotional, physical, and functional impairments than people without voice 
problems and those with chronic diseases such as sinusitis, angina, and back pain. 
Voice problems represent a substantial economic cost due to accumulation of short­
term disability payments and lost wages.24 
Treatment of voice disorders varies but often involves voice therapy and/or surgical 
intervention. Voice therapy, a non-invasive behavioral treatment for voice disorders, 
helps patients develop beneficial voice habits, prevents recurrence of voice 
disorders, and facilitates long-lasting vocal improvement. Many voice therapy 
techniques involve a semi-occluded vocal tract (SOVT). SOVT treatment is often 
characterized by sustained (straw phonation, voiced fricatives, nasals), oral 
oscillatory (lip buzzes, tongue trills, raspberries) or transitory phonation (plosives 
and glides). Straw phonation therapy, one of the most utilized SOVT methods, was 
first proposed in 1904 and involved phonating at different pitches into small glass 
tubes with varying diameters and lengths providing simultaneous semi-occlusion 
and extension of the vocal tract. Voice therapy exercises involving voice production 
with a semi-occluded and sometimes lengthened vocal tract have demonstrated 
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improved vocal efficiency and loudness, reduced mechanical trauma to the vocal 
fold mucosa, and improved source-filter interaction. 
Our group recently developed a semi-occluded facemask for use in patients with 
and without voice disorders. Recent preliminary results using this semi-occluded 
facemask indicated that the use of a certain mask port diameters may elicit voice 
with increased efficiency. A study of 5 participants without voice disorders revealed 
that a mask occlusion diameter of 6.4 and 3.2 mm resulted in improved vocal 
efficiency. A study of the immediate effects of a semi-occluded facemask in 20 
patients with voice disorders revealed that occlusions diameters of 9.6, 6.4, and 3.2 
mm all resulted in significant improvements in acoustic and aerodynamic voice 
outcomes. 
The current study aims to expand upon these past studies by investigating the 
efficacy of use of a semi-occluded facemask in the treatment of patients with voice 
disorders. 
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View: Pitt SF: Study Design 
Study Design 
, Total number of subjects to be enrolled at this site (enter -1 for chart reviews, 
banking, registries): 
30 
Describe and explain the study design: 
Prospective, experimental 
Describe the primary and secondary study endpoints: 
Provide a description of the following study timelines: 
Duration of an individual subject's active participation: 
Approximately 6 weeks 
Duration anticipated to enroll all subjects: 
12-18 months
Estimated date for the investigator to complete this study (complete primary 
analyses): 
12/31/2019 
List the inclusion criteria: 
males and females 
age 18-60 years old 
diagnosed by a multi-disciplinary team consisting of laryngologist and speech­
language pathologist with muscle tension dysphonia (MTD} or vocal fold lesions 
deemed amenable to voice therapy (i.e. not surgical candidates) 
List the exclusion criteria: 
Age 61 or older (excluded due to differences in vocal fold tissue structure changes in 
this age and older) 
Under 18 years of age 
Current smoker (greater than 5 cigarettes/week) 
, Will children or any gender, racial or ethnic subgroups be explicitly excluded 
from participation? 
•Yes QNo
* Identify the subgroups and provide a justification:
Our clinic and therefore voice therapy approaches are for adult populations. Further, 
the developing larynx of children and adolescents is different from the adult larynx. 
Therefore, it is not always appropriate to compare treatments and outcomes 
between pediatric and adult voice disordered populations. 
Describe the power analysis used and cite your method of statistical analysis. 
If a power analysis is not possible, thoroughly justify the sample size required 
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for the study, including appropriate literature citation (alternatively provide 
page reference in attached protocol): 
Due to the pilot nature of the current study, we will use convenience sampling. Our 
clinic evaluates approximately 30 new patients each week. Behavioral voice 
disorders such as those included in the current research are approximately 60% of 
all new patient visits. Therefore, we do not anticipate difficulty recruiting our target N 
of 20 for this pilot investigation. A paired t-test will be used to assess whether VHl-
10 improved significantly from baseline. 
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View: Pitt SF: Research Activities 
Research Activities 
* Provide a detailed description of all research activities (including screening
and follow-up procedures) that will be performed for the purpose of this 
research study. This description of activities should be complete and of 
sufficient detail to permit an assessment of associated risks. 
Participants will be recruited from the University of Pittsburgh Voice Center. 
Participants diagnosed with a voice disorder (including primary MTD, lesions, and 
atrophy) by a board certified speech language pathologist (SLP) will be the target 
population for this study. 
Participants will age 18 and older and must state willingness to attend 4 sessions of 
voice therapy (standard of care for voice therapy for voice disorders) and attend a 
one-week follow-up research testing visit. 
Participants will be assigned to a voice therapist (SLP) and scheduled for 4 
sessions. 
Patients will be given a facemask with a semi-occlusion (SOMask) for use in clinic 
and with a home practice program. 
The therapy program is based on treatment program designed for a semi-occluded 
tube therapy found in the literature and conversation training therapy, a program 
developed by these investigators and validated at this institution (PRO15030497). 
Each voice therapy session will last approximately 45 minutes and will consist of: 
Review of vocal hygiene 
For all exercises, instruct patient to: 
• Breathe outside of mask, phonate into mask
• Abdominal breathing
• Relaxed upper body
• SOMask connected speech- topic of subject's choice
• Auditory and kinesthetic awareness of voice production
• Embedded basic training gesture
• Prosody training
• Negative practice- patient produces the "good" voice, alternating with the "bad"
voice 
Home program: 
• 1 min of mask speech, 4x/day practice
• Record sessions on patient's smart phone for home practice
• Log sheet for homework practice
Baseline data to be collected will be extracted from the medical record. 
Data collected at Baseline: 
• VHl-10 (per usual clinical care)
• auditory perceptual analysis (per usual clinical care)
• Acoustic outcomes in vowels and speech- "we were away a year ago" (per usual
clinical care) 
• Aerodynamic outcomes (per usual clinical care)
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Medical record information will be accessed to collect clinical information related to 
eligibility for this project, and to record voice outcome measure information (such as 
the VHl-10). This information will be collected by individuals involved in this research 
who have normal clinical access to this information or by the research coordinator 
who has been granted access through the Privacy Office. 
All recruitment and enrollment will take place at UPMC Mercy. Voice therapy 
sessions will occur at Mercy, East, and Passavant and Bethel Park. 
Data collected at follow-up: 
• VHl-10
• auditory perceptual analysis
• Acoustic outcomes in vowels and speech- "we were away a year ago"
• Aerodynamic outcomes
• Patient perception of voice therapy questionnaire
• Exit interview about voice therapy
Upload a copy of all materials used to collect data about subjects: (Attach all 
surveys, interview/focus group scripts, and data collection forms except for 
case report forms, SCID or KSADS): 
Document 
. 
Patient Perception of Voice Therapy 
View Ziegler_2014.pdf(0.01) 
Dev and Valid ofVHl-10 Rosen et al-2004-
-
- -
The_Laryngoscope.pdf(0.01) 
Date 
Document 
Category Modified History 
Data 
Collection 1/16/2019 History 
Data 
Collection 1/16/2019 History 
* Will blood samples be obtained for research purposes?
0Yes eNo
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View: Pitt SF: Consent Process 
Consent Process 
Enter NIA in response to the following questions if a Waiver of Consent is requested for all 
research activities or if no subjects are being enrolled. 
* Indicate where the consent process will take place and at what point
consent will be obtained: 
Individuals identified as being eligible during the course of their clinical care visit at 
the University of Pittsburgh Voice Center will be informed of their eligibility by a co­
investigator on this project. If the potential subject shows interest, a member of the 
research team, knowledgeable of the project will review the informed consent 
document with them and address any questions or concerns that arise. Potential 
subjects will be informed that their care at the Voice Center is not dependent on 
participation in this research, and that all research is voluntary. Potential subjects will 
also be informed that they do not have to decide to participate immediately. But we 
ask that they make the decision prior to receiving any voice therapy sessions so as 
not to confound the study results. 
Ultimately, written informed consent will be obtained from the subject by a co­
investigator. 
* Describe the steps that will be taken to minimize coercion and undue
influence, including assurance that there is sufficient time for subjects to 
make an informed decision: 
Individuals will be permitted to take as much time as they need to decide. The only 
stipulation is that they may not have any "traditional" voice therapy sessions after 
determination of eligibility and enrolling into the study as this will confound the 
results. 
For studies that involve multiple visits, describe the process to ensure 
ongoing consent: 
* Steps to be taken to ensure the subjects' understanding:
Individuals identified as being eligible during the course of their clinical care visit at 
the University of Pittsburgh Voice Center will be informed of their eligibility by a co­
investigator on this project. If the potential subject shows interest, a member of the 
research team, knowledgeable of the project will review the informed consent 
document with them and address any questions or concerns that arise. Potential 
subjects will be informed that their care at the Voice Center is not dependent on 
participation in this research, and that all research is voluntary. Potential subjects will 
also be informed that they do not have to decide to participate immediately. But we 
ask that they make the decision prior to receiving any voice therapy sessions so as 
not to confound the study results. 
Ultimately, written informed consent will be obtained from the subject by a co­
investigator. 
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* Are you requesting an exception to the IRB policy related to the informed
consent process:
8Yes QNo 
* Provide a justification and describe the qualifications of the individuals who
will obtain consent:
For this project, the Pl and the Co-investigators have appropriate expertise and
experience to enable them to appropriately discuss the study with participants and
obtain consent.
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View: Pitt SF: Consent Forms 
Consent Forms 
" Consent Forms: 
View 
Document 
Facemask consent PittPRO conv 
2019.docx(0.03) 
Category 
Consent 
Form 
Date 
Modified 
2/8/2019 
Refer to the following templates and instructional documents: 
11 Guidance - Consent Wording 
11 Template - Consent Document - Short Form 
■HRP-090 - SOP - Informed Consent Process for Research
■HRP-091 - SOP - Written Documentation of Consent
Document 
History 
History 
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View: Pitt SF: Medical Records 
Medical Records 
• 
You are required to submit this study to the Research Informatics Office, Health 
Record Research Request (R3). Per UPMC Policy HS-RS000S, all research 
projects that access or involve UPMC electronic protected health information (e­
PHI) must be submitted to R3, with the exception of clinical trials that are 
contracted through the UPMC Office of Sponsored Programs and Research 
Support (OSPARS). 
Complete the R3 intake form available at http://rio.pitt.edu/services. An R3 
representative will conduct a review. You will be notified once your R3 review is 
complete or if anything further is needed. 
* Describe the protected health information that will be collected from the
covered entity and/or the research derived information that will be P-laced into
the medical records:
Medical record information to be accessed for research purposes may include the
information associated with the eligibility of subjects as well as their follow up visit
information. This would include VHl-10 score, computerized voice testing as well as
the clinical examination performed by the laryngologist at any time.
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View: Pitt SF: Electronic Data Management 
Electronic Data Management 
, * Will only anonymous data be collected (select NO if identifiers will be
recorded at anytime during the conduct of the study)?
QYes e No 
Select all identifiers to be collected during any phase of the research including 
screening: 
Name: 
 
Internet Protocol (IP) Address: 
D 
E-mail address:
 
Web Universal Resource Locators (URLs): 
D 
Social security #: 
D 
Social security# (for Vincent payment only): 
 
Phone/Fax#: 
 
Full face photo images or comparable images:  
Account#: 
D 
Health plan beneficiary #: 
D 
Medical record #: 
 
Device identifiers/serial numbers: 
D 
Certificate/license #: D
Vehicle identifiers/serial #/license plate #: 
D 
Biometric identifiers, finger and voice prints: 
D 
a: Will you be collecting any of the following location data: geographic subdivisions smaller 
O Yes e No 
* than a State such as street address, city, county, precinct, zip, geocodes, etc.?
* b: Will you be collecting any date information such as birth date, death, admission, 
e Yes O No
discharge, date of surgery/service?
c: List any other unique identifying numbers, characteristics or codes related to an
individual that are to be collected:
d: Will you be collecting any data subject to the General Data Protection Regulation (GDPR)? O Yes O No
* e: Provide a justification for recording Social Security numbers including why it's required,
where it's stored, how it's protected and who will have access: 
For ALL identifiable data collected, 
will you be coding the data by 
* removing the identifiers and
assigning a unique study ID/code to 
protect the identity of the 
participant? 
eves QNo 
SS# is only 
being collected 
as part of the 
Vincent 
payment 
system. This 
information will 
be stored in 
locked file 
cabinets within 
the locked 
offices of the 
department of 
Otolaryngology. 
Only staff 
involved in the 
payment 
process will 
have access to 
this 
information. 
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* Will the data be HIPAA de-identified? 
0 Yes • No
Briefly describe your plan to store 
* coded data separately from the
identifiable data:
Electronically stored information will be 
de-identified and stored using study IDs.
The linkage information will be stored in 
a separate restricted access folder 
behind the UPMC firewall. 
* Will sensitive data be collected (e.g., protected health information, mental
health, medications, drug/alcohol use, illegal behaviors)? 
eves 0No 
* Select all locations where data will be stored or accessed (including e.g.,
personal/ employer laptop or desktop): 
View 
View 
Storage Device 
UPMC owned desktop,
laptop or other device 
Server: UPMC Managed
Server 
Description 9e
t
ntifiable ge:sitive ;:
-
ntified/Anonymous
a a 
a a 
Data 
no 
no 
no 
yes 
yes 
yes 
* Select all technologies being used to collect data or interact with subjects:
N/A 
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View: Pitt SF: Data Safety and Monitoring 
Data Safety and Monitoring 
, * Describe your plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. The plan 
might include establishing a data monitoring committee and a plan for 
reporting data monitoring committee findings to the IRB and the sponsor: 
The data and safety monitoring plan for this study will involve quarterly meetings 
with the Pl, Co-Investigators and the staff involved to discuss: the integrity and 
confidentiality issues, to monitor data collection and recruitment, and to ensure 
compliance with protocol procedures. A review of research study procedures 
designed to protect the privacy of the research subjects and the confidentiality of 
their research data will be discussed. All breaches of confidentiality will be promptly 
reported to the IRB as well as the Pitt HELP desk. In addition, any unauthorized 
access to medical record information or unanticipated problems shall be reported to 
the IRB. A report will be submitted during the course of the IRB renewal of the study. 
* Describe your plan for sharing data and/or specimens:
This sharing will only occur once the appropriate agreements are executed if 
deemed appropriate by the Office of Research. 
Individuals from both Emory University and Bloomsburg University may be involved 
in the overall conduct of this study. Information shared with Emory and Bloomsburg 
University will be shared in a de-identified manner. 
If any research data is collected, stored, or shared in a paper format, address 
what precautions will be used to maintain the confidentiality of the data: 
Confidentiality will be maintained as per the usual methods in the Dept. of 
Otolaryngology. Any paper documentation will be maintained in locked file cabinets 
within the locked offices of the Department of Otolaryngology. 
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View: Pitt SF: Risk and Benefits 
Risk and Benefits 
. * Enter all reasonably foreseeable risks, discomforts, hazards, or
inconveniences to the subjects related to subjects' participation in the 
research: 
' Research Activity 
Common Risks 
View 
Infrequent Risks 
Common Risks 
View 
Infrequent Risks 
: Other Risks 
Research Activity 
' Common Risks 
View 
: Infrequent Risks 
Other Risks 
medical record review 
No Value Entered 
No Value Entered 
rare risk of breach of confidentiality 
wearing partially occluded mask 
No Value Entered 
No Value Entered 
-emotional discomfort/uncomfortable feeling (as stated in consent) -potential 
for skin irritation due to allergy or mild contact pressure 
voice therapy session 
No Value Entered 
No Value Entered 
rare risk of worsening voice problem 
* Describe the steps that will be taken to prevent or to minimize risks:
Confidentiality will be maintained as per the usual methods in the Dept. of 
Otolaryngology. All electronic subject information will be stored on password 
protected, restricted access servers. Any paper documentation will be maintained in 
locked file cabinets within the locked offices of the Department of Otolaryngology. 
Though uncommon, it is possible that a patient participant's voice could worsen 
during a voice therapy session. If this occurs, the voice therapist will give the 
participant the option of discontinuing voice therapy and can refer the patient back to 
the treating otolaryngologist for repeat vocal fold examination if so desired. 
Wearing of the partially occluded mask could potentially be uncomfortable, 
emotionally for some individuals. The mask is not "fixed" to the individual's face, and 
can be removed by the subject at any time. The subject is in control of holding the 
mask over their nose and mouth. In the event of skin allergy/irritation, mask use may 
need to be discontinued. 
Financial risks • will the subject or insurer be charged for any research 
required procedures? 
QYes 8No 
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Describe the steps that will be taken to protect subjects' privacy: 
All study related procedures will be performed in private rooms as is typical of the 
usual clinical care associated with the diagnosis and treatment of the qualifying 
voice disorders. Information being collected will be limited to the minimum 
necessary to achieve the specific aims in this study and to lay the groundwork for 
future research in this area. 
What steps will be taken in the event that a clinically significant, unexpected 
disease or condition is identified during the conduct of the study: 
All participants will be under the clinical care of physicians in the Department of 
Otolaryngology. Usual clinical practice procedures will be maintained. 
Describe the potential benefit that individual subjects may experience from 
taking part in the research or indicate if there is no direct benefit. Do not 
include benefits to society or others: 
Subjects may actually receive direct benefit in the form of a more rapid recovery 
from their voice disorder than may have been received by completing more 
traditional voice therapy. It is our hypothesis that all subjects will benefit in this way. 
, Do you anticipate any circumstances under which subjects might be 
withdrawn from the research without their consent? 
eves QNo 
* Describe the circumstances and any procedures for orderly termination:
It is possible that individuals may be removed from participation due to a change in
their diagnosis or a change in their treatment plan is recommended.
Describe procedures that will be followed when subjects withdraw from the 
research, including partial withdrawal from procedures with continued data 
collection and data already collected: 
Depending on the circumstances, individuals may be removed from participation 
and directed to alternative methods of treatment if warranted. 
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View: Pitt SF: Conflict of Interest 
Conflict of Interest 
. * Is this an FDA Covered Clinical Study? 
QYes eNo 
Answer YES if it is: 
■A study of a drug or device in humans to be submitted in a marketing
application or reclassification petition that the applicant or FDA relies on to
establish that the product is effective (including studies that show
equivalence to an effective product); or
■A study in which a single investigator makes a significant contribution to the
demonstration of safety.
Do NOT include: 
• phase I tolerance studies or pharmacokinetic studies;
" clinical pharmacology studies (unless they are critical to an efficacy 
determination); 
■large open safety studies conducted at multiple sites;
• treatment protocols; or
" parallel track protocols. 
* Does this study involve a Non-Significant Risk Device and you anticipate
including the results as part of any type of submission to the FDA for approval
of this device?
0Yes eNo 
* Is this study funded in part or whole by a PHS Agency?
QYes eNo
* Does any investigator involved in this study (select all that apply):
A. Have a financial interest (aggregated value of equity and remuneration
0 during the past or next twelve months) in a publicly-traded entity that either 
sponsors this research or owns the technology being evaluated or developed 
that exceeds a 5% ownership interest or a current value of $10,000? 
B. Receive remuneration (during the past or next twelve months) from a non-
□publicly traded entity that either sponsors this research or owns the technology
being evaluated or developed that exceeds $10,000?
D C. Have equity in a non-publicly traded entity that either sponsors this research
or owns the technology being evaluated or developed? 
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D. Have rights as either the author or inventor of intellectual property being
evaluated or developed in this research and for which you are receiving
0 royalties, milestone fees, or other proceeds that have or will exceed $10,000 in
any 12-month period (include payments through the University of Pittsburgh, 
the Veterans Administration Pittsburgh Healthcare System, UPMC, and 
University of Pittsburgh Physicians)? 
0 E. Have an officer or management position with a company that either
sponsors this research or owns the technology being evaluated or developed? 
F. Receive compensation of any amount when the value of the compensation
would be affected by the outcome of this research, such as compensation that
D is explicitly greater for a favorable outcome than for an unfavorable outcome or 
compensation in the form of an equity interest in the entity that either sponsors 
this research or owns the technology being evaluated or developed? 
 None of the above options apply and there are no other financial conflicts of
interest in the conduct of this research. 
Provide the name of the investigator(s) and describe the nature of the 
Significant Financial lnterest(s): 
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View: Pitt SF: Ancillary Reviews 
Ancillary Reviews 
. Ancillary reviews or notifications selected below are required based on 
previous answers to questions. If a selection is incorrect, return to the 
appropriate page and adjust the answers to questions on that page: 
D Conflict of Interest (COi) 
0 Clinical and Translational Research Center (CTRC) 
fJ Data Security 
0 Honest Broker 
0 UPMC lnvestigational Drug Service 
0 Pitt Medical School Review 
0 Pitt+Me 
0 Office of Investigator-Sponsored IND & IDE Support (031S) 
0 Radioactive Drug Research Committee (RDRC)(study involves the evaluation 
or use of procedures that emit ionizing radiation) 
0 ORP Business Manager (required for industry sponsored studies) 
fJ Religious Directives 
fJ Scientific Review 
fJ Health Record Research Request (R3) (required if using UPMC clinical data 
and authorization for other UPMC data sources for research) 
fJ UPMC Office of Sponsored Programs and Research Support (using UPMC 
facilities and/or UPMC patients during the conduct of the study) 
Additional ancillary reviews the Pl may choose to include as needed for the 
research: 
0 Human Stem Cell Oversight (hSCRO) 
D Institutional Biosafety Committee (IBC)(study involves deliberate transfer of 
recombinant or synthetic nucleic acid molecules) 
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View: Pitt SF: Clinical Trials 
Good Clinical Practice (GCP) Training 
* Regardless of funding source, is this study a clinical trial (as defined by the
NIH)? 
eves QNo 
ClinicalTrials.gov Information 
Visit the University of Pittsburgh Office for Clinica/Trials.gov website or contact ctgov@pitt.edu 
for further information. 
* Was this study registered, or will it be registered, on ClinicalTrials.gov?
eves QNo
* Is the University of Pittsburgh or UPMC the Sponsor Organization for this
study record?
eves QNo 
* Who will be the Responsible Party for this study record?
Principal Investigator of this IRS application 
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View: Pitt SF: Supporting Documents 
Supporting Documents 
Attach any additional supporting documents not previously uploaded. Name 
the documents as you want them to appear in the approval letter: 
Date 
Document 
Document 
Category Modified History 
Data Safety and Monitoring 
View Report-PittPRO conversion 
Other 
2/8/2019 History 
2019.docx(0.01) 
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View: Pitt Create 
Add Storage Information 
* Select a Storage Type:
UPMC owned desktop, laptop or other device
Description: 
* Will identifiable data be stored in this location?
OYes 9No
* Will sensitive data be stored in this location?
0Yes 9No
Will de-Identified or anonymous data be stored in this location? 
0Yes 9No 
* Is anti-virus software installed and up to date on all devices and are the
operating systems kept up-to-date on all devices?
9Yes 0No 
. Provide additional information as needed: 
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View: Pitt Create 
Add Storage Information 
. * Select a Storage Type: 
Server: UPMC Managed Server 
Description: 
* Will identifiable data be stored in this location?
0Yes QNo
* Will sensitive data be stored in this location?
0Yes 0No
Will de-Identified or anonymous data be stored in this location? 
OYes 0No 
Provide additional information as needed: 
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Risk 
, * Research Activity:
medical record review 
Common Risks: 
Infrequent Risks: 
Other Risks: 
Print: STUDY19010151 - Efficacy of a variably-occluded facemask in voice therapy 
View: Pitt Risk 
rare risk of breach of confidentiality 
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View: Pitt Risk 
Risk 
, * Research Activity:
wearing partially occluded mask 
Common Risks: 
Infrequent Risks: 
Other Risks: 
-emotional discomfort/uncomfortable feeling (as stated in consent) -potential for skin
irritation due to allergy or mild contact pressure 
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Risk 
. * Research Activity:
voice therapy session 
Common Risks: 
Infrequent Risks: 
Other Risks: 
Print: STUDY19010151 - Efficacy of a variably-occluded facemask in voice therapy 
View: Pitt Risk 
rare risk of worsening voice problem 
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