Effects of External Vibration on Voice Quality in Muscle Tension Dysphonia Patients and Classically Trained Singers

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT02083341
First received: March 5, 2014
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

Muscle tension dysphonia (MTD) is a disabling voice disorder which causes severe voice change, neck pain, and voice fatigue. Current therapy modalities to treat these disorders include multiple visits to a qualified speech language pathologist (SLP) for rehabilitation with voice exercises and focused laryngeal/neck massage. Access to these services is difficult with long waitlists and often not covered by current public health insurance or locally available to many patients in Ontario. The goal of this study is to demonstrate a reduction in symptoms and improvement in vocal function by applying an external vibration device to key sites (e.g. jaw, neck, skull base) commonly identified as a source of abnormal muscle tension and injury in certain voice disorders, specifically MTD.

This study will also investigate the effect of external vibration on the voice quality in classically trained singers (CTSs). Certain desirable acoustic qualities in a singers' voice are only accessible when the larynx and its extrinsic muscles are in a relaxed state. Muscle misuse and vocal strain are common problems in performers, which can result in conditions that require surgery and speech therapy, and may lead to a loss of income. Similar to vocal warm up exercises which contribute to the prevention of vocal injury, external vibration is expected to improve muscle perfusion in an acute setting and may have a direct effect on vocal fold cover viscosity.

Both study groups will be randomized to receive either the external vibration device or a sham device. The sham device looks identical to the experimental device but has the vibration component removed.


Condition Intervention
Muscle Tension Dysphonia
Classically Trained Singers
Device: Lelo® Siri vibrator
Device: Lelo® Siri vibrator with vibration component removed

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • jitter [ Time Frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy) ] [ Designated as safety issue: No ]
    acoustic measurement from voice recordings

  • shimmer [ Time Frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy) ] [ Designated as safety issue: No ]
    acoustic measurement from voice recordings

  • signal to noise ratio [ Time Frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy) ] [ Designated as safety issue: No ]
    acoustic measurement from voice recordings

  • fundamental frequency [ Time Frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy) ] [ Designated as safety issue: No ]
    acoustic measurement from voice recordings

  • singing power ratio (singer group only) [ Time Frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy) ] [ Designated as safety issue: No ]
    acoustic measurement from voice recordings; captured for the singer group only


Estimated Enrollment: 40
Study Start Date: May 2014
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MTD
external vibration device
Device: Lelo® Siri vibrator
external vibration device
Sham Comparator: MTD - Sham
external vibration device - sham
Device: Lelo® Siri vibrator with vibration component removed
external vibration device - sham
Experimental: CTS
external vibration device
Device: Lelo® Siri vibrator
external vibration device
Sham Comparator: CTS - Sham
external vibration device - sham
Device: Lelo® Siri vibrator with vibration component removed
external vibration device - sham

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

MTD Inclusion Criteria:

  • Diagnosed with primary MTD

MTD Exclusion Criteria:

  • Active smoker
  • Currently receiving voice therapy from a SLP
  • Currently receiving botox injections
  • Past laryngeal surgery

CTS Inclusion Criteria:

  • Professional or semi-professional classical singer
  • Third year university performance major or greater CTS Exclusion Criteria
  • Active smoker
  • Known voice disorders
  • Past laryngeal surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02083341

Locations
Canada, Ontario
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Jennifer Anderson, MD, FRCS(C)         
Sub-Investigator: Mary Enid Haines, MusBacPerf, MA         
Sub-Investigator: Gwen Merrick, MHSc, Reg. CASLPO         
Sub-Investigator: Marta Deluca, MClSc, MusBacPerf, SLP (C)         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Jennifer Anderson, MD, FRCS(C) Chief, Department of Otolaryngology - Head and Neck Surgery
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02083341     History of Changes
Other Study ID Numbers: VVT-01, AHSC AFP Innovation Fund
Study First Received: March 5, 2014
Last Updated: March 10, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Dysphonia
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014