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

NCT ID: NCT02083341

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-01-15

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.

Conditions

Dysphonia; Singing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lelo® Siri vibrator

Intervention Type: DEVICE

external vibration device

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.

Group Type: SHAM_COMPARATOR

Lelo® Siri vibrator with vibration component removed

Intervention Type: DEVICE

external vibration device - sham

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.

Group Type: EXPERIMENTAL

Lelo® Siri vibrator

Intervention Type: DEVICE

external vibration device

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.

Group Type: SHAM_COMPARATOR

Lelo® Siri vibrator with vibration component removed

Intervention Type: DEVICE

external vibration device - sham

Interventions

Lelo® Siri vibrator

external vibration device

Intervention Type: DEVICE

Lelo® Siri vibrator with vibration component removed

external vibration device - sham

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosed with primary MTD

• Professional or semi-professional classical singer

Exclusion Criteria

• Active smoker
• Currently receiving voice therapy from a SLP
• Currently receiving botox injections
• Past laryngeal surgery

• Active smoker
• Known voice disorders
• Past laryngeal surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Anderson, MD, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Chief, Department of Otolaryngology - Head and Neck Surgery

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29270622 (View on PubMed)

Other Identifiers

AHSC AFP Innovation Fund

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VVT-01

Identifier Type: -

Identifier Source: org_study_id