Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02788435
NCT02788435
Unknown
Not Applicable

The Role of Voice Rest on Voice Outcomes Following Phonosurgery: A Randomized-Controlled Trial

Lawson Health Research Institute1 site in 1 country50 target enrollmentJuly 2016
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsUnilateral Vocal Cord Lesions

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unilateral Vocal Cord Lesions
Sponsor
Lawson Health Research Institute
Enrollment
50
Locations
1
Primary Endpoint
Voice Handicap Index (VHI)-10
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Patients undergoing vocal cord surgery (phonosurgery) are often prescribed voice rest postoperatively. However, no clinical trials have ever been conducted to ascertain the efficacy of using voice rest and its impact on functional voice outcomes. The purpose of this randomized-clinical trial is to determine if the prescription of voice rest has an impact on voice outcomes following phonosurgery.

Detailed Description

The study will seek to determine if a 7-day period of absolute voice rest alters voice-related quality of life following phonosurgery

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
June 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Age greater than 18 years
  • •Unilateral vocal cord lesion
  • •Consented for phonosurgery

Exclusion Criteria

  • •Age less than 18 years
  • •Bilateral vocal cord lesions
  • •Prior vocal cord surgery

Outcomes

Primary Outcomes

Voice Handicap Index (VHI)-10

Time Frame: 12 weeks post-operative

Secondary Outcomes

  • Frequency perturbation (jitter)(12 weeks post-operative)
  • Fundamental frequency(12 weeks post-operative)
  • Maximum phonation time(12 weeks post-operative)
  • Perceptual grading of voice using the Grade, Roughness, Breathiness, Asthenia, Strain, Instability (GRBASI)-scale(12 weeks post-operative)
  • Amplitude perturbation (shimmer)(12 weeks post-operative)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
The Role of Vocal Rest After Removal of Benign Lesions From Vocal CordVocal Fold PolypVocal Cord Dysfunction
NCT03046706Rambam Health Care Campus100
Terminated
Not Applicable
Impact of Duration Of Absolute Voice Rest on Voice Outcome After PhonomicrosurgeryBenign Neoplasm of True Vocal Cords
NCT02634957University of Pittsburgh17
Unknown
Not Applicable
Optimal Duration of Voice Rest After Surgery for Benign Vocal LesionsVocal Fold PolypVocal Cord CystVocal Nodules in Adults
NCT04319432Tel-Aviv Sourasky Medical Center40
Completed
Phase 1
Efficacy of voice rest and voice therapy after vocal fold surgeryThe patients who will undergo laryngomicrosurgery for leukoplakia, carcinoma, vocal fold polyp, polypoid and cyst.
JPRN-UMIN000008319Department of Otolaryngology Head and Neck Surgery Graduate School of Medicine Kyoto University20
Completed
Not Applicable
Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine SurgeryDysphagiaDysphonia
NCT01017055University of Alabama at Birmingham200