Voice DisordersNCT00237679
Quantifying Effects of Treatment of Pediatric Dysphonia
A study testing Neuromuscular Electrical Stimulation and Unstimulated in people with Voice Disorders and Gastroesophageal Reflux, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The diagnosis and management of childhood dysphonia is a significant clinical problem; however, there have been few studies aimed at defining standard assessment methods for pediatric dysphonia. Accordingly, pediatric dysphonia is difficult to diagnose and it is difficult to quantify change following treatment. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Voice Disorders, Gastroesophageal Reflux
- What is being tested?
- Neuromuscular Electrical Stimulation and Unstimulated
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Dec 2008
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- chronic dysphonia with suspected extraesophageal reflux
Who cannot join
- previous reflux treatment.
- laryngeal disorder treated primarily with surgery
Trial locations and contacts
1 site in 1 country.
About this study
The diagnosis and management of childhood dysphonia is a significant clinical problem; however, there have been few studies aimed at defining standard assessment methods for pediatric dysphonia. Accordingly, pediatric dysphonia is difficult to diagnose and it is difficult to quantify change following treatment. The long-term goal of this research program is to develop valid, responsive, reliable, and age-appropriate methods for assessing vocal pathology in children. In the present small grant, our objective is to define assessment methods that are appropriate for use in determining response to treatment. Our main focus, therefore, is the issue of assessment responsivity. The first specific aim is to develop a set of responsive measures of vocal pathology in school-aged children by inducing short-term change in vocal status via behavioral and medical management of extraesophageal reflux disease (EERD). Because we are treating children suspected of EERD, this study also presents the opportunity for examining the benefits of combined vocal hygiene and medical management in the treatment of pediatric EERD. Accordingly, our second specific aim is to determine predictive criteria for improvement in vocal status in dysphonic children suspected of EERD. Our hypothesis is that a particular set of measurements will emerge as particularly responsive to change in vocal pathology in this population, and will allow for informed prediction of degree of improvement with treatment. The proposed research is significant in filling a gap in knowledge in childhood dysphonia assessment and treatment, which are important clinical issues consistent with the mission and intent of the NIDCD. Because phonatory disorders in children may have lasting negative effects, studies geared toward accurate assessment and treatment are very important.
- Conditions
- Voice Disorders, Gastroesophageal Reflux
- Being tested
- Neuromuscular Electrical Stimulation, Unstimulated
- Keywords
- behavior therapy, combination therapy, gastrointestinal disorder chemotherapy, human therapy evaluation, larynx disorder, middle childhood (6-11), lansoprazole, reflux esophagitis, quality of life, clinical research, human subject, laryngoscopy, patient oriented research, questionnaire
- Medical subject headings
- Voice Disorders, Gastroesophageal Reflux, Laryngeal Diseases, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationBehavioural
Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction.
UnstimulatedBehavioural
No current is generated.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Electrical Stimulation | Active comparator | Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy. Receives: Behavioral: Neuromuscular Electrical Stimulation |
| Unstimulated | Sham comparator | Subjects will receive sham (unstimulated) swallow therapy combined with exercise therapy. Receives: Behavioral: Unstimulated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.
Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Terminated due to funding loss.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- J. Scott McMurray, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237679
- Sponsor's protocol ID
- 2000-487
- Other IDs
- R03DC005917
- Status last verified
- Oct 2015
- First submitted
- 7 Oct 2005
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Effects of Treatment of Pediatric Dysphonia
- ClinicalTrials.gov ID
- NCT00237679
- Acronym / sponsor ID
- 2000-487
- Conditions
- Voice Disorders, Gastroesophageal Reflux
- Keywords
- behavior therapy, combination therapy, gastrointestinal disorder chemotherapy, human therapy evaluation, larynx disorder, middle childhood (6-11), lansoprazole, reflux esophagitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to funding loss.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jan 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Oct 2005 (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.
The diagnosis and management of childhood dysphonia is a significant clinical problem; however, there have been few studies aimed at defining standard assessment methods for pediatric dysphonia. Accordingly, pediatric dysphonia is difficult to diagnose and it is difficult to quantify change following treatment. The long-term goal of this research program is to develop valid, responsive, reliable, and age-appropriate methods for assessing vocal pathology in children. In the present small grant, our objective is to define assessment methods that are appropriate for use in determining response to treatment. Our main focus, therefore, is the issue of assessment responsivity. The first specific aim is to develop a set of responsive measures of vocal pathology in school-aged children by inducing short-term change in vocal status via behavioral and medical management of extraesophageal reflux disease (EERD). Because we are treating children suspected of EERD, this study also presents the opportunity for examining the benefits of combined vocal hygiene and medical management in the treatment of pediatric EERD. Accordingly, our second specific aim is to determine predictive criteria for improvement in vocal status in dysphonic children suspected of EERD. Our hypothesis is that a particular set of measurements will emerge as particularly responsive to change in vocal pathology in this population, and will allow for informed prediction of degree of improvement with treatment. The proposed research is significant in filling a gap in knowledge in childhood dysphonia assessment and treatment, which are important clinical issues consistent with the mission and intent of the NIDCD. Because phonatory disorders in children may have lasting negative effects, studies geared toward accurate assessment and treatment are very important.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Electrical Stimulation | Active comparator | Behavioral: Neuromuscular Electrical StimulationSubjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy. |
| Unstimulated | Sham comparator | Behavioral: UnstimulatedSubjects will receive sham (unstimulated) swallow therapy combined with exercise therapy. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- chronic dysphonia with suspected extraesophageal reflux
Key exclusion criteria (2 listed)
- previous reflux treatment.
- laryngeal disorder treated primarily with surgery
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 |
|---|---|---|
| Neuromuscular Electrical StimulationThrough low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction. | Behavioural | Neuromuscular Electrical Stimulation |
| UnstimulatedNo current is generated. | Behavioural | Unstimulated |
Primary outcome
Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.
Time frame: 3 years
Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.
Results and safety
The study was stopped early (reason given: Terminated due to funding loss.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
Related trials for Voice Disorders
Recruiting
Our Voices Matter: Intervention for Depression in Youth
Depressive Symptoms, Allostatic Load
Not yet recruitingPhase 1/2
Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
Head and Neck Squamous Cell Carcinoma, HPV-Negative Squamous Cell Carcinoma
Active, not recruitingObservational study
VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
Crohn's Disease
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
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.
J. Scott McMurray, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation and Unstimulated in people with Voice Disorders and Gastroesophageal Reflux, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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: stopped early, as of the sponsor's last update on 14 Oct 2015. 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 United States. 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 was stopped early (reason given: Terminated due to funding loss.). Results are not available in the source record.
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?
Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2015.