NCT02217111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

July 9, 2014

Last Update Submit

January 21, 2016

Conditions

Vocal Fold Nodules

Keywords

vocal fold nodulespediatricvoice therapyacousticaerodynamicquality of lifeAdventures in Voice

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Spectral and Cepstral Analysis

    13-16 weeks

  • Vital Capacity (Aerodynamic Analysis)

    13-16 weeks

  • Developmental Neuropsychological Assessment (NEPSY) (Cognitive Assessment)

    13-16 weeks

  • Browns ADD Scales (Cognitive Assessment)

    13-16 weeks

  • Children's Memory Scale (Cognitive Assessment)

    13-16 weeks

  • +2 more secondary outcomes

Study Arms (1)

voice therapy

EXPERIMENTAL
Behavioral: Adventures in Voice: Pediatric Voice Therapy

Interventions

Adventures in Voice: Pediatric Voice TherapyBEHAVIORAL
voice therapy

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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:

  • Hearing loss: \> 20 dB hearing loss at 1000, 2000, 4000 Hz in at least one ear.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Study Officials

  • Katherine Verdolini Abbott, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2014

First Posted

August 15, 2014

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations

US(2)