Randomized Controlled Trial of Voice on Children With Vocal Nodules

Completed

• Conditions: Vocal Fold Nodules

• Registration Number: NCT01255735
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Brief Summary

The primary objective of this study is to determine the impact of voice therapy on voice-related quality of life in children age 6-10 years old with apparent vocal fold nodules, as measured by the validated Pediatric Voice-Related Quality of Life Instrument (PVRQOL)administered 4 weeks after completion of voice therapy.

Detailed Description

Voice disorders place over five million school-aged children at increased risk for inferior school performance, dysfunctional social development, and higher participation in criminal activities. The lesions most commonly associated with pediatric vocal dysfunction are reported to be vocal fold nodules, which are present in up to 21% of the general pediatric population and are associated with behavioral problems and inferior quality of life. Voice therapy with a speech-language pathologist is recommended by 95% of otolaryngologists for management of vocal fold nodules. When implemented, this voice therapy requires significant time investment and typically results in regular absence from the classroom over a period of 1-3 months or longer, depending on the protocol and the setting. Regular absence from school has been shown to place children at risk for poorer scholastic performance but the benefits of this voice therapy have yet to be demonstrated in any rigorous prospective, controlled trial. Thus, the most widely used treatment for the most common lesion associated with pediatric voice disorders has not been rigorously tested in a randomized controlled trial to determine whether it may have benefits.

A randomized clinical trial addressing whether voice therapy improves voice-related quality of life for children with apparent vocal fold nodules is a logical step toward developing an evidence-based treatment plan to optimize outcomes for this sizable population of at-risk children. There are currently no well-powered, prospective, controlled studies which compare voice therapy versus control in children who present with apparent nodules. Our goal is to remedy this deficiency through testing of the following primary null hypothesis: There is no difference in the change in PVRQOL scores after 3 months of treatment with voice therapy versus office instructions.

Study Timeline

• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Study Start: 2011-01
• Primary Completion: 2015-10
• Status Verified: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pediatric Voice-Related Quality of Life Instrument (PVRQOL)	Administered at Screening, Baseline, Therapy Completion, and Follow-Up	The PVRQOL consists of 10 questions completed by parent proxy administration that requires approximately 5 minutes to complete. It measures the parent's assessment of their child's overall quality of life as related to their vocal condition.

Secondary Outcome Measures

Name	Time	Method
Harmonics-to-Noise Ration [HNR)	Completed at Baseline, Therapy Completion, and Follow-Up	Recordings will be analyzed using KayPENTAX's Computerized Speech Lab (CSL). To analyze the steady state vowel productions, the steadiest one second segment from the mid portion of each vowel production will be selected from the digitized waveform for analysis, and HNR results for that segment will be obtained using CSL software.
"Consensus Auditory-Perceptual Evaluation of Voice" (CAPE-V)	Completed at Baseline, Therapy Completion, and Follow-Up	The CAPE-V specifies standardized procedures for the perceptual evaluation of voice, including standardized recording conditions, word stimuli and rating procedures.
Nodule grade	Completed at Baseline and Follow-Up	A grading system for vocal fold nodules has been validated with established inter-rater reliability for nodule presence and size. The 3-point grading scale for nodule size will be used with grade 1 being small, grade 2 a moderate nodule, and grade 3 a large nodule. The contour of the nodule will also be rated as either discrete or sessile. One secondary objective of the study is to compare nodule grade across baseline and 12 (or 16) weeks. Changes in grade are compared for subjects treated with voice therapy versus office instructions alone.
Phonation Threshold Pressure (PTP)	Completed at Baseline, Therapy Completion, and Follow-Up	The aerodynamic measures obtained will focus on estimated Phonation Threshold Pressure (PTP), defined as the minimum amount of subglottal pressure required to initiate and sustain vocal fold oscillation. These measures will be obtained in a non-invasive manner from oral pressures generated during repetitive production of five consonant-vowel-consonant (CVC) strings (/pae pae pae pae pae/.

Trial Locations

Locations (4)

Drexell University College of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

The Hospital For Sick Children; 🇨🇦 Toronto, Ontario, Canada

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States