DysphoniaNCT02083341
Effects of External Vibration on Voice Quality in Muscle Tension Dysphonia Patients and Classically Trained Singers
A study testing Lelo® Siri vibrator and Lelo® Siri vibrator with vibration component removed in people with Dysphonia and Singing, run by Unity Health Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Lelo® Siri vibrator and Lelo® Siri vibrator with vibration component removed
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to 15 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Lelo® Siri vibrator, Lelo® Siri vibrator with vibration component removed
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lelo® Siri vibratorDevice
external vibration device
Lelo® Siri vibrator with vibration component removedDevice
external vibration device - sham
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Lelo® Siri vibrator with vibration component removed |
What is being measured
The primary outcome is the main question the study is designed to answer.
jitter
acoustic measurement from voice recordings
Measured: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
Secondary outcomes (4)
shimmer
acoustic measurement from voice recordings
Measured: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
signal to noise ratio
acoustic measurement from voice recordings
Measured: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
fundamental frequency
acoustic measurement from voice recordings
Measured: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
singing power ratio (singer group only)
acoustic measurement from voice recordings; captured for the singer group only
Measured: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startAug 2014
- Primary completion15 Jan 2016
- Study completion15 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysphoniaStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Anderson, MD, FRCS(C), Principal investigator, Chief, Department of Otolaryngology - Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083341
- Sponsor's protocol ID
- VVT-01
- Other IDs
- AHSC AFP Innovation Fund
- Status last verified
- Sep 2018
- First submitted
- 5 Mar 2014
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29270622
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of External Vibration on Voice Quality in Muscle Tension Dysphonia Patients and Classically Trained Singers
- ClinicalTrials.gov ID
- NCT02083341
- Acronym / sponsor ID
- VVT-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 15 Jan 2016 (actual)
- Study completion
- 15 Jan 2016 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Muscle tension dysphonia - treatment | Experimental | Device: Lelo® Siri vibratorexternal 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 | Sham comparator | Device: Lelo® Siri vibrator with vibration component removedexternal 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 | Experimental | Device: Lelo® Siri vibratorexternal 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 - Sham | Sham comparator | Device: Lelo® Siri vibrator with vibration component removedexternal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lelo® Siri vibratorexternal vibration device | Device | Classically trained singers, Muscle tension dysphonia - treatment |
| Lelo® Siri vibrator with vibration component removedexternal vibration device - sham | Device | Classically trained singers - Sham, Muscle tension dysphonia - Sham |
Primary outcome
jitter
Time frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
acoustic measurement from voice recordings
4 secondary outcomes
shimmer
Time frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
signal to noise ratio
Time frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
fundamental frequency
Time frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
singing power ratio (singer group only)
Time frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Derived from this study: PubMed 29270622Anderson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Anderson, MD, FRCS(C) principal investigator
Chief, Department of Otolaryngology - Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lelo® Siri vibrator and Lelo® Siri vibrator with vibration component removed in people with Dysphonia and Singing, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
jitter (time frame: measured at beginning and end of 1 hour study visit (before and after external vibration therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.