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

Primary Purpose

Dysphonia, Singing

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lelo® Siri vibrator
Lelo® Siri vibrator with vibration component removed
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Muscle tension dysphonia - treatment

Muscle tension dysphonia - Sham

Classically trained singers

Classically trained singers - Sham

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

jitter
acoustic measurement from voice recordings

Secondary Outcome Measures

shimmer
acoustic measurement from voice recordings
signal to noise ratio
acoustic measurement from voice recordings
fundamental frequency
acoustic measurement from voice recordings
singing power ratio (singer group only)
acoustic measurement from voice recordings; captured for the singer group only

Full Information

First Posted
March 5, 2014
Last Updated
September 4, 2018
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02083341
Brief Title
Effects of External Vibration on Voice Quality in Muscle Tension Dysphonia Patients and Classically Trained Singers
Official Title
Effects of External Vibration on Voice Quality in Muscle Tension Dysphonia Patients and Classically Trained Singers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 15, 2016 (Actual)
Study Completion Date
January 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphonia, Singing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Muscle tension dysphonia - treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Muscle tension dysphonia - Sham
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Classically trained singers
Arm Type
Experimental
Arm Description
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.
Arm Title
Classically trained singers - Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lelo® Siri vibrator
Intervention Description
external vibration device
Intervention Type
Device
Intervention Name(s)
Lelo® Siri vibrator with vibration component removed
Intervention Description
external vibration device - sham
Primary Outcome Measure Information:
Title
jitter
Description
acoustic measurement from voice recordings
Time Frame
measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
Secondary Outcome Measure Information:
Title
shimmer
Description
acoustic measurement from voice recordings
Time Frame
measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
Title
signal to noise ratio
Description
acoustic measurement from voice recordings
Time Frame
measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
Title
fundamental frequency
Description
acoustic measurement from voice recordings
Time Frame
measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
Title
singing power ratio (singer group only)
Description
acoustic measurement from voice recordings; captured for the singer group only
Time Frame
measured at beginning and end of 1 hour study visit (before and after external vibration therapy)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Anderson, MD, FRCS(C)
Organizational Affiliation
Chief, Department of Otolaryngology - Head and Neck Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29270622
Citation
Anderson J, DeLuca M, Haines ME, Merrick G. Immediate Effects of External Vibration vs Placebo on Vocal Function Therapy in Singers: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Mar 1;144(3):187-193. doi: 10.1001/jamaoto.2017.2679.
Results Reference
derived

Learn more about this trial

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

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