DysphoniaNCT03129880
Intensive Versus Traditional Voice Therapy
A study testing Weekly Voice Therapy and Intensive Voice Therapy in people with Dysphonia, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine if there are differences in treatment outcomes between traditional voice therapy, performed weekly for a maximum of 6 weeks versus intensive voice therapy, consisting of 4-6 therapy sessions performed within one day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphonia
- What is being tested?
- Weekly Voice Therapy and Intensive Voice Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2016to 12 Mar 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with a Voice disorder
- Diagnosed with benign vocal fold lesions and/or hyper-function
- First/primary propose treatment modality is voice therapy
- Patients who are appropriate for either standard of care treatment modality (traditional or intensive voice therapy)
- Willingness to participate in either standard of care treatment modality
- All races
- Males and females
- English speaking
Who cannot join
- Younger than 18
- Inability or unwillingness to participate in one of the standard of care treatment modalities
- Laryngeal Surgery or procedures during course of study
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison Voice and Swallow Clinic
Madison, Wisconsin, 53792
About this study
Official title: Voice-related Outcomes in Response to Intensive Versus Traditional Therapy Programs
The purpose of this study is to determine if there are differences in treatment outcomes between traditional voice therapy, performed weekly for a maximum of 6 weeks versus intensive voice therapy, consisting of 4-6 therapy sessions performed within one day.
Read the detailed description
The goal of voice therapy is optimal long-term vocal quality and communication function with minimal recurrence. Traditional voice therapy for dysphonia typically consists of one to two therapy sessions each week with a single clinician for about 8 weeks. Another approach of voice therapy is intensive short-term therapy also known as "boot camp." This approach, borrows from the disciplines of neurobiology, exercise physiology, motor learning, and psychotherapy which describe desirable learning and behavior changes influenced by practice that involves high-intensity overload, variability, and specificity of training. A few studies have showed that "Boot Camp" model of intensive therapy resulted in comparable gains in voice quality and vibratory mechanics and may promote better patient satisfaction and attendance.
While such findings support the notion that intensive voice therapy may enhance voice therapy outcomes, no study to date has examined patient response to the "Boot Camp" approach to voice therapy. The investigators will compare the outcomes of traditional, weekly voice therapy and intensive voice therapy with multiple sessions in one day.
- Conditions
- Dysphonia
- Being tested
- Weekly Voice Therapy, Intensive Voice Therapy
- Keywords
- Voice disorder, Hoarseness, Phonation Disorders, Speech Disorders
- Medical subject headings
- Dysphonia, Voice Disorders, Hoarseness, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly Voice TherapyBehavioural
Participants will be randomized to receive weekly voice therapy
Intensive Voice TherapyBehavioural
Participants will be randomized to receive multiple sessions of voice therapy in one day.
| Study group | Role | What they receive |
|---|---|---|
| Weekly Voice Therapy | Placebo comparator | Participants are randomized to receiving weekly voice therapy sessions Receives: Behavioral: Weekly Voice Therapy |
| Intensive Voice Therapy | Active comparator | Participants are randomized to receiving multiple sessions of voice therapy in one day Receives: Behavioral: Intensive Voice Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy and readiness scale Changes
Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
Measured: Baseline compared to Immediately post voice therapy
Self-efficacy and readiness scale Change
Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
Measured: Baseline compared to 12 weeks post voice therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start13 Mar 2016
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphoniaStudies of the same condition, open and under way.
- 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
- Model description
- For purposes of this study participants will be randomized into one of the following two groups: 4-6 weekly standard of care therapy sessions, once a week, for a maximum of six weeks 4-6 standard of care therapy sessions in one day Standard of care treatment may continue past patient enrollment in this study.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emerald J Doll, MS, CCC-SLP, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129880
- Sponsor's protocol ID
- 2015-0763
- Other IDs
- A539772, SMPH/SURGERY/SPEECH, Protocol Version 12/2/2020
- Status last verified
- May 2024
- First submitted
- 18 Apr 2017
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice-related Outcomes in Response to Intensive Versus Traditional Therapy Programs
- ClinicalTrials.gov ID
- NCT03129880
- Acronym / sponsor ID
- 2015-0763
- Conditions
- Dysphonia
- Keywords
- Voice disorder, Hoarseness, Phonation Disorders, Speech Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 13 Mar 2016 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 26 Apr 2017 (actual)
- 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 purpose of this study is to determine if there are differences in treatment outcomes between traditional voice therapy, performed weekly for a maximum of 6 weeks versus intensive voice therapy, consisting of 4-6 therapy sessions performed within one day.
Detailed description
The goal of voice therapy is optimal long-term vocal quality and communication function with minimal recurrence. Traditional voice therapy for dysphonia typically consists of one to two therapy sessions each week with a single clinician for about 8 weeks. Another approach of voice therapy is intensive short-term therapy also known as "boot camp." This approach, borrows from the disciplines of neurobiology, exercise physiology, motor learning, and psychotherapy which describe desirable learning and behavior changes influenced by practice that involves high-intensity overload, variability, and specificity of training. A few studies have showed that "Boot Camp" model of intensive therapy resulted in comparable gains in voice quality and vibratory mechanics and may promote better patient satisfaction and attendance.
While such findings support the notion that intensive voice therapy may enhance voice therapy outcomes, no study to date has examined patient response to the "Boot Camp" approach to voice therapy. The investigators will compare the outcomes of traditional, weekly voice therapy and intensive voice therapy with multiple sessions in one day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For purposes of this study participants will be randomized into one of the following two groups: 4-6 weekly standard of care therapy sessions, once a week, for a maximum of six weeks 4-6 standard of care therapy sessions in one day Standard of care treatment may continue past patient enrollment in this study.
| Arm | Type | Receives |
|---|---|---|
| Weekly Voice Therapy | Placebo comparator | Behavioral: Weekly Voice TherapyParticipants are randomized to receiving weekly voice therapy sessions |
| Intensive Voice Therapy | Active comparator | Behavioral: Intensive Voice TherapyParticipants are randomized to receiving multiple sessions of voice therapy in one day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with a Voice disorder
- Diagnosed with benign vocal fold lesions and/or hyper-function
- First/primary propose treatment modality is voice therapy
- Patients who are appropriate for either standard of care treatment modality (traditional or intensive voice therapy)
- Willingness to participate in either standard of care treatment modality
Key exclusion criteria (4 listed)
- Younger than 18
- Inability or unwillingness to participate in one of the standard of care treatment modalities
- Laryngeal Surgery or procedures during course of study
- Prisoners
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 |
|---|---|---|
| Weekly Voice TherapyParticipants will be randomized to receive weekly voice therapy | Behavioural | Weekly Voice Therapy |
| Intensive Voice TherapyParticipants will be randomized to receive multiple sessions of voice therapy in one day. | Behavioural | Intensive Voice Therapy |
Primary outcome
Self-efficacy and readiness scale Changes
Time frame: Baseline compared to Immediately post voice therapy
Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
Self-efficacy and readiness scale Change
Time frame: Baseline compared to 12 weeks post voice therapy
Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
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 16 May 2024.
- 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.
Emerald J Doll, MS, CCC-SLP 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 Weekly Voice Therapy and Intensive Voice Therapy in people with Dysphonia, 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 16 May 2024. 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 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?
Self-efficacy and readiness scale Changes (time frame: Baseline compared to Immediately post voice therapy). The study lists 2 primary outcomes in all. 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 16 May 2024.