Vocal Fold NodulesNCT02217111
Prospective Study of Voice Therapy in Children: A Pilot Study
A study testing Adventures in Voice: Pediatric Voice Therapy in people with Vocal Fold Nodules, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The purpose of this prospective study is to obtain preliminary data on changes in pre-post voice therapy outcomes in children diagnosed with vocal fold nodules, as a function of a series of cognitive operations. The primary outcome is voice-related quality of life (questionnaire). Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Vocal Fold Nodules
- What is being tested?
- Adventures in Voice: Pediatric Voice Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to May 2015
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of vocal fold nodules.
- Age 4-11 yr.
- Informed Consent.
- English comprehension and production sufficient to participate in the protocol and in voice therapy.
- Considered behaviorally and cognitively appropriate by the ear, nose, and throat physician and speech-language pathologist for voice therapy.
- Parent and child willingness to participate in all aspects of the protocol and voice therapy.
Who cannot join
- Co-morbid medical conditions or medications that would mask or amplify the outcome of voice therapy, including (a) developmental or other neuromuscular conditions, (b) major illness, chronic or acute, with the exception of laryngopharyngeal reflux disease (LPR) or allergies and their treatments, which are common in both children and adults with voice disorders, thus their exclusion would severely restrict the participant pool and, moreover, threaten external validity.
- Hearing loss: > 20 dB hearing loss at 1000, 2000, 4000 Hz in at least one ear.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
The purpose of this prospective study is to obtain preliminary data on changes in pre-post voice therapy outcomes in children diagnosed with vocal fold nodules, as a function of a series of cognitive operations. The primary outcome is voice-related quality of life (questionnaire). Secondary outcomes are standard acoustic and aerodynamic measures derived from sustained vowel and running speech samples.
Read the detailed description
- Voice disorders are the most common communication disorder across the lifespan, affecting more than 5 million school-aged children annually in the United States.
- Vocal fold nodules are the most frequent pathology affecting voice in children, and may affect up to 21% of the pediatric population at any given point in time.
- Children with voice disorders caused by this and other conditions often experience negative consequences in quality of life and academic participation.
- Specifically, these children are at increased risk for inferior school performance, dysfunctional psychosocial development, and other negative sequelae.
- Overwhelmingly, the first-line treatment for voice problems due to nodules is behavioral voice therapy.
- Unfortunately, the pediatric population is badly underserved by Speech-Language Pathology for this condition and others affecting voice.
- Moreover, to date, experimental findings on the benefits of voice therapy in children have not been reported.
- In the present study, children who present with voice complaints to the Department of Otolaryngology at Children's Hospital of Pittsburgh (CHP), who are diagnosed with vocal fold nodules, and who following informed consent are found to satisfy other inclusion criteria detailed shortly, will be eligible for participation in the study.
- Eligible children will undergo a 45-60-min battery of standardized tests evaluating simple cognitive functions.
- Participation in the protocol will not depend on the outcome of these tests.
- Then, all children will receive an increasingly used, 9-week program of voice therapy for children with vocal fold nodules and other conditions affecting voice, "Adventures in Voice," a program grounded in basic biomechanical, biological, and cognitive science.
- Dependent variables will be pre- to post-therapy change in voice-related quality-of-life, based on the Pediatric Voice-Related Quality of Life Survey (Boseley, Cunningham, Volk, \& Hartnick, 2006) (primary outcome measure) and change in a series of standard acoustic and aerodynamic measures based on sustained vowel and simple running speech samples, described shortly (secondary outcome measures).
- The independent variables involve a series of cognitive measures.
- Conditions
- Vocal Fold Nodules
- Being tested
- Adventures in Voice: Pediatric Voice Therapy
- Keywords
- vocal fold nodules, pediatric, voice therapy, acoustic, aerodynamic, quality of life, Adventures in Voice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adventures in Voice: Pediatric Voice TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| voice therapy | Experimental | Not described Receives: Behavioral: Adventures in Voice: Pediatric Voice Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Voice-Related Quality of Life Survey (PVRQOL)
The PVRQOL is a 10-item instrument designed and validated as a self-administered and parent-proxy-administered instrument for the pediatric population with voice disorders to measure both social-emotional and physical-functional aspects of voice problems. The PVRQOL raw scores are transformed to a scale of 0-100 for easy of interpretation. The PVRQOL will be administered prior to initiation of voice therapy as well as one week post-voice therapy termination.
Measured: 13-16 weeks
Secondary outcomes (7)
Spectral and Cepstral Analysis
Cepstral peak measures and associated Spectral measurements will be obtained using the Analysis of Dysphonia in Speech and Voice (ADSV) program for the following voice sample tasks: (1) sustained vowel /a/, (2) standard sentences (based on the Consensus Auditory-Perceptual Evaluation of Voice, 2006), and (3) counting from 1-10. The ADSV program will provide the following seven (7) key measures obtained from Spectral, Cepstral, or combination of Spectral and Cepstral measures: (1) The Cepstral Peak Prominence (CPP), (2) The Cepstral Peak Prominence standard deviation (CPP sd); (3) The Low/High Spectral Ratio (L/H Ratio using a default cutoff of 4 kHz); (4) The L/H Ratio standard deviation; (5) The CPP frequency (an estimate of the fundamental frequency (F0) obtained form the Cepstral peak); (6) The CPP frequency standard deviation; and (7) The Cepstral Spectral Index of Dysphonia (CSID) - a multivariate acoustic estimate of dysphonia severity using a 100mm visual analog scale (VAS).
Measured: 13-16 weeks
Vital Capacity (Aerodynamic Analysis)
Hand held spirometry (EasyOne) will be used to obtain estimates of Vital Capacity. The Vital Capacity measure will be used to calculate estimated laryngeal airflow with phonatory quotient (VC (mL/s) / MPT (s)).These measures will be performed at baseline and one-week post-therapy follow up.
Measured: 13-16 weeks
Developmental Neuropsychological Assessment (NEPSY) (Cognitive Assessment)
This test evaluates executive function, memory, attention, and sensorimotor functions, and is completed by the child. It is standardized for children ages 3-16 yr. The test will be administered before pre- and post- voice therapy.
Measured: 13-16 weeks
Browns ADD Scales (Cognitive Assessment)
These Scales evaluate potential Attention Deficit Disorder (ADD), but may be appropriate for children without ADD as well. This test is completed by the guardian, and can be administered concurrently with administration of other tests to the child. The battery will be administered pre- and post-voice therapy.
Measured: 13-16 weeks
Children's Memory Scale (Cognitive Assessment)
This test assesses verbal and visual short- and long-term memory. It is standardized for children as young as 5 yr of age, but most 4-yr-old children should be able to complete the test. The test will be administered before pre- and post- voice therapy.
Measured: 13-16 weeks
Maximum Phonation Time (Aerodynamic Analysis)
Will provide indirect estimates of respiratory, in relation to phonatory, function. These measures will be performed at baseline and one-week post-therapy follow up.
Measured: 13-16 weeks
S/Z Ratio (Aerodynamic Analysis)
Will provide indirect estimates of respiratory, in relation to phonatory, function. These measures will be performed at baseline and one-week post-therapy follow up.
Measured: 13-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Fold NodulesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittie Verdolini Abbott, University of Pittsburgh
- Investigators
- Katherine Verdolini Abbott, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217111
- Sponsor's protocol ID
- PRO14060563
- Status last verified
- Jan 2016
- First submitted
- 9 Jul 2014
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Voice Therapy in Children: A Pilot Study
- ClinicalTrials.gov ID
- NCT02217111
- Acronym / sponsor ID
- PRO14060563
- Conditions
- Vocal Fold Nodules
- Keywords
- vocal fold nodules, pediatric, voice therapy, acoustic, aerodynamic, quality of life, Adventures in Voice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective study is to obtain preliminary data on changes in pre-post voice therapy outcomes in children diagnosed with vocal fold nodules, as a function of a series of cognitive operations. The primary outcome is voice-related quality of life (questionnaire). Secondary outcomes are standard acoustic and aerodynamic measures derived from sustained vowel and running speech samples.
Detailed description
- Voice disorders are the most common communication disorder across the lifespan, affecting more than 5 million school-aged children annually in the United States.
- Vocal fold nodules are the most frequent pathology affecting voice in children, and may affect up to 21% of the pediatric population at any given point in time.
- Children with voice disorders caused by this and other conditions often experience negative consequences in quality of life and academic participation.
- Specifically, these children are at increased risk for inferior school performance, dysfunctional psychosocial development, and other negative sequelae.
- Overwhelmingly, the first-line treatment for voice problems due to nodules is behavioral voice therapy.
- Unfortunately, the pediatric population is badly underserved by Speech-Language Pathology for this condition and others affecting voice.
- Moreover, to date, experimental findings on the benefits of voice therapy in children have not been reported.
- In the present study, children who present with voice complaints to the Department of Otolaryngology at Children's Hospital of Pittsburgh (CHP), who are diagnosed with vocal fold nodules, and who following informed consent are found to satisfy other inclusion criteria detailed shortly, will be eligible for participation in the study.
- Eligible children will undergo a 45-60-min battery of standardized tests evaluating simple cognitive functions.
- Participation in the protocol will not depend on the outcome of these tests.
- Then, all children will receive an increasingly used, 9-week program of voice therapy for children with vocal fold nodules and other conditions affecting voice, "Adventures in Voice," a program grounded in basic biomechanical, biological, and cognitive science.
- Dependent variables will be pre- to post-therapy change in voice-related quality-of-life, based on the Pediatric Voice-Related Quality of Life Survey (Boseley, Cunningham, Volk, \& Hartnick, 2006) (primary outcome measure) and change in a series of standard acoustic and aerodynamic measures based on sustained vowel and simple running speech samples, described shortly (secondary outcome measures).
- The independent variables involve a series of cognitive measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| voice therapy | Experimental | Behavioral: Adventures in Voice: Pediatric Voice Therapy |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis of vocal fold nodules.
- Age 4-11 yr.
- Informed Consent.
- English comprehension and production sufficient to participate in the protocol and in voice therapy.
- Considered behaviorally and cognitively appropriate by the ear, nose, and throat physician and speech-language pathologist for voice therapy.
Key exclusion criteria (2 listed)
- Co-morbid medical conditions or medications that would mask or amplify the outcome of voice therapy, including (a) developmental or other neuromuscular conditions, (b) major illness, chronic or acute, with the exception of laryngopharyngeal reflux disease (LPR) or allergies and their treatments, which are common in both children and adults with voice disorders, thus their exclusion would severely restrict the participant pool and, moreover, threaten external validity.
- Hearing loss: > 20 dB hearing loss at 1000, 2000, 4000 Hz in at least one ear.
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 |
|---|---|---|
| Adventures in Voice: Pediatric Voice Therapy | Behavioural | voice therapy |
Primary outcome
Pediatric Voice-Related Quality of Life Survey (PVRQOL)
Time frame: 13-16 weeks
The PVRQOL is a 10-item instrument designed and validated as a self-administered and parent-proxy-administered instrument for the pediatric population with voice disorders to measure both social-emotional and physical-functional aspects of voice problems. The PVRQOL raw scores are transformed to a scale of 0-100 for easy of interpretation. The PVRQOL will be administered prior to initiation of voice therapy as well as one week post-voice therapy termination.
7 secondary outcomes
Spectral and Cepstral Analysis
Time frame: 13-16 weeks
Vital Capacity (Aerodynamic Analysis)
Time frame: 13-16 weeks
Developmental Neuropsychological Assessment (NEPSY) (Cognitive Assessment)
Time frame: 13-16 weeks
Browns ADD Scales (Cognitive Assessment)
Time frame: 13-16 weeks
Children's Memory Scale (Cognitive Assessment)
Time frame: 13-16 weeks
Maximum Phonation Time (Aerodynamic Analysis)
Time frame: 13-16 weeks
S/Z Ratio (Aerodynamic Analysis)
Time frame: 13-16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
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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.
Katherine Verdolini Abbott, Ph.D. principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adventures in Voice: Pediatric Voice Therapy in people with Vocal Fold Nodules, run by University of Pittsburgh at 2 sites 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 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Voice-Related Quality of Life Survey (PVRQOL) (time frame: 13-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.