Randomized Controlled Trial of Voice on Children With Vocal Nodules

NCT01255735 | Completed DMC

• 1 other identifier: 10-04-024
• Study Type: observational
• Target: 114
• Locations: 2 countries
• Sites: 4

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.

Conditions

Vocal Fold Nodules

Keywords

pediatrics; voice; voice therapy; vocal therapy; hoarseness

Outcome Measures

Primary Outcomes (1)

• Pediatric Voice-Related Quality of Life Instrument (PVRQOL)

  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.

  Administered at Screening, Baseline, Therapy Completion, and Follow-Up

Secondary Outcomes (4)

• "Consensus Auditory-Perceptual Evaluation of Voice" (CAPE-V)

  Completed at Baseline, Therapy Completion, and Follow-Up

• Phonation Threshold Pressure (PTP)

  Completed at Baseline, Therapy Completion, and Follow-Up

• Harmonics-to-Noise Ration [HNR)

  Completed at Baseline, Therapy Completion, and Follow-Up

• Nodule grade

  Completed at Baseline and Follow-Up

Study Arms (1)

Vocal nodules

Two groups of children who are hoarse and have vocal nodules will be examined to see whether voice therapy is effective as a treatment strategy

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children ages 6-10 who have hoarseness and vocal nodules

You may not qualify if:

• Children 6 to10 years of age will be enrolled. The rationale for this age range was previously noted. In brief, children in this age range (a) have similar educational and social exposures; (b) will likely not yet encounter pubertal changes affecting the larynx; and (c) are relatively cognitively homogeneous. Moreover, children in this age range have the ability to cooperate with voice therapy and have also been shown to be tolerant of stroboscopic examination. Finally, the voice therapy regimen in this protocol has been shown to be clinically effective for many children in this age range.
• Voice-related quality of life must be affected to the extent that baseline PVRQOL scores are \<87.5 (on a scale of the worst, 0, to the best, 100) at the time of entry into the trial. Based on previously published data, this subset of scores will be clearly distinct from scores in children with normal voices. In addition, scores \<87.5 represent worse than average scores among children diagnosed with vocal fold nodules.
• Dysphonia duration prior to randomization must be at least 12 weeks, in order to ensure that vocal dysfunction is chronic in nature.
• Hearing in better ear of 35 dB or better.
• Agreement by informed consent from the parents and informed assent from the child participant with anticipated commitment to compliance throughout the follow up period of 3 months is necessary for enrollment which includes time commitment of up to 3 hours per week to therapy sessions and homework.
• Children who have previously received any form of speech therapy targeting voice and/or resonance with the exception of articulation or speech therapy.
• Children for whom voice therapy protocols will be problematic are excluded: developmental delay, cognitive disorder, behavioral disorder, neurologic disorder, articulation disorder, phonological disorder, language disorder, expressive and/or receptive language delay, specific language impairment, central auditory processing disorder, fluency disorder, prior knowledge of voice therapy principles through previous interventions (with the exception of articulation or speech therapy), and inability to commit to at least 12 weeks of therapy as determined and evaluated by the treating speech language pathologist and confirmed by consensus of all three PIs.
• Children whose caregivers cannot complete the primary endpoint are excluded: non-English speaking as the PVRQOL instrument is administered in English, and those unable to commit to the 3-month treatment and follow-up schedule.
• Children whose caregivers are not willing to commit up to 3 hours per week to vocal therapy including therapy sessions and homework for up to 12 weeks.
• Children who cannot tolerate a conscious video-stroboscopic examination and whose parents feel that the diagnostic information gained by a planned examination under anesthesia is not valuable for the severity of presenting symptoms are excluded.
• Children with significant confounders of voice-related quality of life are excluded: vocal fold paralysis, neurologic disorder of the larynx (dystonias, tics, tremors, etc), ongoing acute upper respiratory tract infection (defined by at least 2 of the following: sneezing, coughing, nasal congestion, runny nose, or temperature greater than 100.4° F (38.0° C), and untreated or unsuccessfully treated allergic rhinitis/post nasal drip.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Drexel University College of Medicine: collaborator
• Medical College of Wisconsin: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (4)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Drexell University College of Medicine

Philadelphia, Pennsylvania, 19103, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

The Hospital For Sick Children

Toronto, Ontario, Canada

Location

Related Publications (1)

• Hartnick C, Ballif C, De Guzman V, Sataloff R, Campisi P, Kerschner J, Shembel A, Reda D, Shi H, Sheryka Zacny E, Bunting G. Indirect vs Direct Voice Therapy for Children With Vocal Nodules: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Feb 1;144(2):156-163. doi: 10.1001/jamaoto.2017.2618.

  PMID: 29270612 DERIVED

MeSH Terms

Conditions

Hoarseness

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Officials

• Christopher Hartnick, MD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: January 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2016
• Last Updated: December 2, 2016

Record last verified: 2016-11

Locations

US (3); CA (1)