Clinical trial NCT02217111: Prospective Study of Voice Therapy in Children: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vocal Fold Nodules
Keywords: vocal fold nodules
pediatric
voice therapy
acoustic
aerodynamic
quality of life
Adventures in Voice
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 12
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pediatric Voice-Related Quality of Life Survey (PVRQOL)
timeFrame: 13-16 weeks
Secondary outcomes:
measure: Spectral and Cepstral Analysis
timeFrame: 13-16 weeks
measure: Vital Capacity (Aerodynamic Analysis)
timeFrame: 13-16 weeks
measure: Developmental Neuropsychological Assessment (NEPSY) (Cognitive Assessment)
timeFrame: 13-16 weeks
measure: Browns ADD Scales (Cognitive Assessment)
timeFrame: 13-16 weeks
measure: Children's Memory Scale (Cognitive Assessment)
timeFrame: 13-16 weeks
measure: Maximum Phonation Time (Aerodynamic Analysis)
timeFrame: 13-16 weeks
measure: S/Z Ratio (Aerodynamic Analysis)
timeFrame: 13-16 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Katherine Verdolini Abbott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: