DysphoniaNCT05237648
Assessing the Effects of Patient Self-Rating of Voice Quality on Voice Therapy Attendance and Outcomes
A study testing Online Voice quality education module and Vocal hygiene module in people with Dysphonia, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of incorporating educational online modules into voice therapy. One of the main reasons that voice therapy fails is lack of participation and engagement from the patient's side. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dysphonia
- What is being tested?
- Online Voice quality education module and Vocal hygiene module
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2023to 22 Oct 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- English-speaking
- Have access to technology, including Internet
- Diagnosed with dysphonia with a recommended treatment of voice therapy.
- Willingness to complete all clinical/research assessments
- Ability to give informed consent
Who cannot join
- Patients who undergo surgical intervention during the course of therapy Contraindications for participation in voice therapy
- Diagnosis of Parkinson's Disease or other neurodegenerative, progressive disorder (e.g., ALS)
- Previous training in acoustic-perceptual voice quality rating, for example a speech language pathology student
- Visual impairments that would prevent the completion of an online module.
- Those with self-reported moderate-profound hearing loss or deafness that would preclude them from participating in the study
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the effects of incorporating educational online modules into voice therapy. One of the main reasons that voice therapy fails is lack of participation and engagement from the patient's side. The researchers hope to learn if increasing patient engagement via educational online modules during this waiting period between evaluation and first therapy session is useful in increasing understanding of the therapeutic framework of voice therapy.
Read the detailed description
Attendance and adherence are established as consistent challenges in voice therapy. Specific logistical and psychological factors linked to these challenges include the interval between evaluation and initiation of treatment and components of patient motivation. The authors propose a novel online education module involving patient self-ratings of voice quality to be completed at various time points throughout the therapeutic process, including during the waiting period between initial evaluation and first treatment session. The authors hypothesize that completion of this module will increase patient understanding of the conceptual framework of therapy, provide opportunities for inclusion of patient-driven acoustic goals and establish skills in auditory and kinesthetic awareness, which are foundational to behavioral voice therapy.
- Conditions
- Dysphonia
- Being tested
- Online Voice quality education module, Vocal hygiene module
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Voice quality education moduleOther
The novel online module the authors developed consists of a patient education on acoustic-perceptual rating of voice quality (CAPE-V), practice rating sample recordings of others' voices, and the patient's self-rating of their own voice in real time during a standard sentence-reading task. The module also includes the Self-Efficacy Scale for Voice Therapy.
Vocal hygiene moduleOther
The generic online patient education module on vocal hygiene during the waiting period between their initial evaluation and their first therapy session that also includes the Self-Efficacy Scale for Voice Therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants will complete an online module with content focusing on patient self-rating of vocal quality within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session; Receives: Other: Online Voice quality education module |
| Sham Control Group | Sham comparator | Participants will complete an online module within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session with content focusing on vocal hygiene. Receives: Other: Vocal hygiene module |
| Control group | No intervention | Participants will not complete an online module. The groups will be compared in terms of attendance, self-efficacy, and treatment outcome measures based on the data collected within the NYU Voice Center standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of voice handicap perception across the 3 groups
Will be measured by Voice Handicap Index -10 (VHI-10), a patient reported outcome measure used to record the patient's perception of impairment or handicap due to a voice problem. A score of over 10 is considered to be abnormal. The scores in all three groups will be compared and analyzed.
Measured: Baseline (Day 1) visit, 8 - 10 week visit
Change of Online education module acceptance across the 3 groups
Will be measured by attendance data (number of sessions recommended versus attended, number of no shows) using the standard patient data collected according to standard of care process.
Measured: Baseline Visit (Day 1), Last day of visit (up to 4 months from baseline)
Secondary outcomes (3)
Change of perceived effectiveness of voice therapy
Self-Efficacy Scale for Voice Therapy will assess a patient's self-perception of their ability to achieve a goal. The Self-Efficacy Scale for Voice Therapy prompts patients to be "brutally honest" and rate their perceived capability to accomplish practice or generalization of skills in various daily and therapeutic situations and activities. Patients are asked to rate their certainty in these capabilities from 0 to 10, where 0 is not at all certain and 10 is extremely certain.
Measured: Baseline (Day 1) visit, 8 - 10 week visit
Change of patient's perception on voice therapy
Comparison of scores on the Patient Perception of Voice Therapy Questionnaire for therapy completers across the three groups as well as between those subjects who completed an online module (experimental and sham control groups) and those who did not (control group alone).
Measured: Baseline (Day 1) visit, 8 - 10 week visit
Change of perceptual voice ratings
CAPE-V will be used to measure experimental group patients and clinician perceptual voice rating. The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) indicates salient perceptual vocal attributes, identified by the core consensus group as commonly used and easily understood. The attributes are: (a) Overall Severity; (b) Roughness; (c) Breathiness; (d) Strain; (e) Pitch; and (f) Loudness. The CAPE-V displays each attribute accompanied by a 100- millimeter line forming a visual analog scale (VAS). The clinician indicates the degree of perceived deviance from normal for each parameter on this scale, using a tic mark.
Measured: Baseline (Day 1) visit, 8 - 10 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start19 Jan 2023
- Primary completion22 Oct 2024
- Study completion22 Oct 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.
- More trials run by NYU Langone HealthThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Johnson, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237648
- Sponsor's protocol ID
- 21-01409
- Status last verified
- Nov 2025
- First submitted
- 21 Jan 2022
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of Patient Self-Rating of Voice Quality on Voice Therapy Attendance and Outcomes
- ClinicalTrials.gov ID
- NCT05237648
- Acronym / sponsor ID
- 21-01409
- Conditions
- Dysphonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 14 Feb 2022 (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 assess the effects of incorporating educational online modules into voice therapy. One of the main reasons that voice therapy fails is lack of participation and engagement from the patient's side. The researchers hope to learn if increasing patient engagement via educational online modules during this waiting period between evaluation and first therapy session is useful in increasing understanding of the therapeutic framework of voice therapy.
Detailed description
Attendance and adherence are established as consistent challenges in voice therapy. Specific logistical and psychological factors linked to these challenges include the interval between evaluation and initiation of treatment and components of patient motivation. The authors propose a novel online education module involving patient self-ratings of voice quality to be completed at various time points throughout the therapeutic process, including during the waiting period between initial evaluation and first treatment session. The authors hypothesize that completion of this module will increase patient understanding of the conceptual framework of therapy, provide opportunities for inclusion of patient-driven acoustic goals and establish skills in auditory and kinesthetic awareness, which are foundational to behavioral voice therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Online Voice quality education moduleParticipants will complete an online module with content focusing on patient self-rating of vocal quality within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session; |
| Sham Control Group | Sham comparator | Other: Vocal hygiene moduleParticipants will complete an online module within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session with content focusing on vocal hygiene. |
| Control group | No intervention | –Participants will not complete an online module. The groups will be compared in terms of attendance, self-efficacy, and treatment outcome measures based on the data collected within the NYU Voice Center standard of care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years
- English-speaking
- Have access to technology, including Internet
- Diagnosed with dysphonia with a recommended treatment of voice therapy.
- Willingness to complete all clinical/research assessments
Key exclusion criteria (6 listed)
- Patients who undergo surgical intervention during the course of therapy Contraindications for participation in voice therapy
- Diagnosis of Parkinson's Disease or other neurodegenerative, progressive disorder (e.g., ALS)
- Previous training in acoustic-perceptual voice quality rating, for example a speech language pathology student
- Visual impairments that would prevent the completion of an online module.
- Those with self-reported moderate-profound hearing loss or deafness that would preclude them from participating in the study
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 |
|---|---|---|
| Online Voice quality education moduleThe novel online module the authors developed consists of a patient education on acoustic-perceptual rating of voice quality (CAPE-V), practice rating sample recordings of others' voices, and the patient's self-rating of their own voice in real time during a standard sentence-reading task. The module also includes the Self-Efficacy Scale for Voice Therapy. | Other | Experimental Group |
| Vocal hygiene moduleThe generic online patient education module on vocal hygiene during the waiting period between their initial evaluation and their first therapy session that also includes the Self-Efficacy Scale for Voice Therapy | Other | Sham Control Group |
Primary outcome
Change of voice handicap perception across the 3 groups
Time frame: Baseline (Day 1) visit, 8 - 10 week visit
Will be measured by Voice Handicap Index -10 (VHI-10), a patient reported outcome measure used to record the patient's perception of impairment or handicap due to a voice problem. A score of over 10 is considered to be abnormal. The scores in all three groups will be compared and analyzed.
Change of Online education module acceptance across the 3 groups
Time frame: Baseline Visit (Day 1), Last day of visit (up to 4 months from baseline)
Will be measured by attendance data (number of sessions recommended versus attended, number of no shows) using the standard patient data collected according to standard of care process.
3 secondary outcomes
Change of perceived effectiveness of voice therapy
Time frame: Baseline (Day 1) visit, 8 - 10 week visit
Change of patient's perception on voice therapy
Time frame: Baseline (Day 1) visit, 8 - 10 week visit
Change of perceptual voice ratings
Time frame: Baseline (Day 1) visit, 8 - 10 week visit
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 28 Nov 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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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.
Aaron Johnson, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Voice quality education module and Vocal hygiene module in people with Dysphonia, run by NYU Langone Health 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 6 inclusion and 6 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 28 Nov 2025. 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?
Change of voice handicap perception across the 3 groups (time frame: Baseline (Day 1) visit, 8 - 10 week visit). 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 28 Nov 2025.