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

Not Applicable

Completed

• Conditions: Singing; Dysphonia
• Interventions: Device: Lelo® Siri vibrator; Device: Lelo® Siri vibrator with vibration component removed

• Registration Number: NCT02083341
• Lead Sponsor: Unity Health Toronto

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-11
• Study Start: 2014-08
• Primary Completion: 2016-01-15
• Study Completion: 2016-01-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

Inclusion Criteria

• Diagnosed with primary MTD

MTD

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Muscle tension dysphonia - treatment	Lelo® Siri vibrator	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.
Classically trained singers	Lelo® Siri vibrator	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.
Muscle tension dysphonia - Sham	Lelo® Siri vibrator with vibration component removed	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.
Classically trained singers - Sham	Lelo® Siri vibrator with vibration component removed	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.

Primary Outcome Measures

Name	Time	Method
jitter	measured at beginning and end of 1 hour study visit (before and after external vibration therapy)	acoustic measurement from voice recordings

Secondary Outcome Measures

Name	Time	Method
signal to noise ratio	measured at beginning and end of 1 hour study visit (before and after external vibration therapy)	acoustic measurement from voice recordings
fundamental frequency	measured at beginning and end of 1 hour study visit (before and after external vibration therapy)	acoustic measurement from voice recordings
shimmer	measured at beginning and end of 1 hour study visit (before and after external vibration therapy)	acoustic measurement from voice recordings
singing power ratio (singer group only)	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

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada