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Completed

NCT Number: NCT02083341

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lelo® Siri vibrator

Device

external vibration device

Lelo® Siri vibrator with vibration component removed

Device

external vibration device - sham

Primary outcomes

  1. jitter

    Time frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)

    acoustic measurement from voice recordings

Secondary outcomes

  1. shimmer

    Time frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)

    acoustic measurement from voice recordings

  2. signal to noise ratio

    Time frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)

    acoustic measurement from voice recordings

  3. fundamental frequency

    Time frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)

    acoustic measurement from voice recordings

  4. singing power ratio (singer group only)

    Time frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)

    acoustic measurement from voice recordings; captured for the singer group only

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2014
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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