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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| voice therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adventures in Voice: Pediatric Voice Therapy | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13-16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Verdolini Abbott, Ph.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States | ||
| University of Pittsburgh |
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| 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. | 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. | 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. | 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. | 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. | 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. | 13-16 weeks |
| Pittsburgh |
| Pennsylvania |
| 15260 |
| United States |