Recruiting

Voice Rest

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT02788435

Conditions

Unilateral Vocal Cord Lesions

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Absolute Voice Rest

Study Details

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.

Conditions

Unilateral Vocal Cord Lesions

Study ID

NCT02788435

Start date

Jul, 2016

Status verified date

Aug, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

Patients in the control arm will undergo a graduated prescription of voice use immediately following surgery.

experimental: Absolute Voice Rest

Patients in the experimental arm will undergo 7 days of absolute voice rest following surgery.

Interventions

Absolute Voice Rest

Patients will be instructed to not use their voice and minimize any voice-use activities such as coughing or throat-clearing for a period of 7 days following surgery.

Primary outcome measure

  • Voice Handicap Index (VHI)-10 [ Time Frame: 4 weeks post-operative ]
  • Voice Handicap Index (VHI)-10 [ Time Frame: 12 weeks post-operative ]

Central Contacts and Locations

Central contacts

Kevin Fung, MD, FRCSC

Kevin.Fung@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Aug 15, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2018-08-15.