Prospective Study of Voice Therapy in Children: A Pilot Study

Completed · Not applicable

Conditions studied: Vocal Fold Nodules

In brief

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.

Key facts

Study ID

NCT02217111

Run by

University of Pittsburgh

People needed

12

Starts

2015-01-01

Expected to finish

2015-05-01

Last updated by the study team

2016-01-25

Who can join

Age: 4 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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