NCT02083341

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2016

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

March 5, 2014

Last Update Submit

September 4, 2018

Conditions

DysphoniaSinging

Outcome Measures

Primary Outcomes (1)

  • jitter

    acoustic measurement from voice recordings

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

Secondary Outcomes (4)

  • shimmer

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

  • signal to noise ratio

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

  • fundamental frequency

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

  • singing power ratio (singer group only)

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

Study Arms (4)

Muscle tension dysphonia - treatment

EXPERIMENTAL

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

Muscle tension dysphonia - Sham

SHAM COMPARATOR

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

Classically trained singers

EXPERIMENTAL

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

Classically trained singers - Sham

SHAM COMPARATOR

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

Interventions

Lelo® Siri vibratorDEVICE

external vibration device

Classically trained singersMuscle tension dysphonia - treatment
Lelo® Siri vibrator with vibration component removedDEVICE

external vibration device - sham

Classically trained singers - ShamMuscle tension dysphonia - Sham

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with primary MTD

You may not qualify if:

  • Active smoker
  • Currently receiving voice therapy from a SLP
  • Currently receiving botox injections
  • Past laryngeal surgery
  • Professional or semi-professional classical singer
  • Active smoker
  • Known voice disorders
  • Past laryngeal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 29270622DERIVED

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Anderson, MD, FRCS(C)

    Chief, Department of Otolaryngology - Head and Neck Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 11, 2014

Study Start

August 1, 2014

Primary Completion

January 15, 2016

Study Completion

January 15, 2016

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)