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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 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: May 29, 2015
Last verified: May 2015
  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
Dysphonia
Singing
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
Official Title: Effects of External Vibration on Voice Quality in Muscle Tension Dysphonia Patients and Classically Trained Singers

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


Secondary Outcome Measures:
  • 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: August 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Muscle tension dysphonia - treatment
external vibration device. A prospective, randomized, placebo controlled, single blinded study design will be used to investigate the effects of an external vibration device on voice acoustic parameters and perceptual in MTD patients and singers. The external vibration device to be investigated is the Lelo® Siri vibrator. The external vibration therapy sessions, and pre and post acoustic recordings will be conducted by a SLP.
Device: Lelo® Siri vibrator
external vibration device
Sham Comparator: Muscle tension dysphonia - Sham
external vibration device - sham. A prospective, randomized, placebo controlled, single blinded study design will be used to investigate the effects of an external vibration device on voice acoustic parameters and perceptual in MTD patients and singers. The external vibration device to be investigated is the Lelo® Siri vibrator. The external vibration therapy sessions, and pre and post acoustic recordings will be conducted by a SLP. Lelo® Siri vibrator with vibration component removed.
Device: Lelo® Siri vibrator with vibration component removed
external vibration device - sham
Experimental: Classically trained singers
external vibration device. A prospective, randomized, placebo controlled, single blinded study design will be used to investigate the effects of an external vibration device on voice acoustic parameters and perceptual in MTD patients and singers. The external vibration device to be investigated is the Lelo® Siri vibrator. The external vibration therapy sessions, and pre and post acoustic recordings will be conducted by a SLP.
Device: Lelo® Siri vibrator
external vibration device
Sham Comparator: Classically trained singers - Sham
external vibration device - sham. A prospective, randomized, placebo controlled, single blinded study design will be used to investigate the effects of an external vibration device on voice acoustic parameters and perceptual in MTD patients and singers. The external vibration device to be investigated is the Lelo® Siri vibrator. The external vibration therapy sessions, and pre and post acoustic recordings will be conducted by a SLP. Lelo® Siri vibrator with vibration component removed.
Device: Lelo® Siri vibrator with vibration component removed
external vibration device - sham

Detailed Description:

Muscle tension dysphonia is primarily treated with voice therapy with a qualified SLP. One of the key therapy tools for MTD is laryngeal extrinsic muscle massage along with voice and respiratory exercises. Access to these specialized services is difficult due to limited expertise and travel distance. 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. If the study shows a demonstrable benefit, patients would be trained to self administer the treatment along with a home program of therapy exercises. This novel therapy would improve delivery of care and allow speech therapy services to be more widely accessible with reduced number of therapy sessions required. The potential long term effects would be to decrease wait times to access these specialized services and lessen the need for return visits due to symptom recurrence.

The second part of this study is to investigate the effect of external vibration on the voice quality in 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.

  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 Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Jennifer Anderson, MD    416 864 5278    andersonj@smh.ca   
Contact: William To, MSc    4168646060 ext 6591    tow@smh.ca   
Principal Investigator: Jennifer Anderson, MD, FRCS         
Sub-Investigator: Mary Enid Haines, MBF, MA         
Sub-Investigator: Gwen Merrick, MHSc, CAS         
Sub-Investigator: Marta Deluca, MClSc, SLP         
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: May 29, 2015
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 01, 2015