DysphoniaPhase 4AAONCT02286960
Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
A Phase 4 study testing Steroid and Lactose Pills in people with Dysphonia, run by NYU Langone Health at 1 site in United States.
Trial summary
Despite the considerable use of oral steroids in the regular management of benign vocal fold lesions there is little evidence base in the literature. This study will investigate the efficacy of oral steroids for the treatment of vocal fold lesions in a controlled manner. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphonia
- What is being tested?
- Steroid and Lactose Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80 males and females
- Presence of phonotraumatic lesion deemed to be etiologic for the complaint of dysphonia
- Voice therapy deemed to be the primary (or at least initial) treatment to address the dysphonia.
- Willingness to be an active participant in voice therapy.
Who cannot join
- Use of any glucocorticoids (oral, inhaled, or intravenous) within 3 months of the initial evaluation
- Known allergy or hypersensitivity to oral steroids
- Active infection
- Diabetes Mellitus
- Prior history of radiation to the neck
- Recent myocardial infarction
Show all 11Show fewer
- Recent gastrointestinal surgery with bowel anastamosis (3 months)
- Active peptic ulcer
- Pregnancy
- Severe depression or history of psycosis
- History of recent laryngeal surgery (within 12 months)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Despite the considerable use of oral steroids in the regular management of benign vocal fold lesions there is little evidence base in the literature. This study will investigate the efficacy of oral steroids for the treatment of vocal fold lesions in a controlled manner. The specific aim of this study is to determine the effectiveness of of a short course of oral steroids prior to behavioral voice therapy in patients with benign, phonotraumatic vocal fold lesions. Enrolled subjects will be randomized using a random numbers table to either receive oral steroids or no steroids prior to the initiation of voice therapy. The therapist and individuals involved in the collection and analysis of data will be blinded as to whether the subject received drug. Prior to initiation of therapy subjects will be asked to return for an interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation to determine the best mode of therapy they will receive a behavioral voice therapy course, which includes a range of behavioral modifications and motor learning techniques, along with lifestyle measures. In all these phases acoustic and aerodynamic measurements will be collected as well as audio-visual material from the videostroboscopic exams. The investigators hypothesize that oral steroids will lead to a reduction in lesion size, which will substantially aid in the delivery and incorporation of voice therapy techniques, contributing to the improvement of overall laryngeal biomechanics and providing an ideal starting point for behavioral voice therapy.
Read the detailed description
The study will investigate the potential added advantage of the use of steroids in patients undergoing voice therapy. Enrolled subjects will be randomized using a random numbers table to either receive oral steroids or no steroids prior to the initiation of voice therapy. The therapist and individuals involved in the collection and analysis of data will be blinded as to whether the subject received drug. Prior to initiation of therapy subjects will be asked to return for an interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation to determine the best mode of therapy they will receive a behavioral voice therapy course, which includes a range of behavioral modifications and motor learning techniques, along with lifestyle measures. In all these phases acoustic and aerodynamic measurements will be collected as well as audio-visual material from the videostroboscopic exams. The measurements that will be collected in all these phases are the Voice Handicap Index (VHI)-10 , the noise to harmonic ratio H/N, the fundamental frequency Fo, The transglottic airflow and subglottic pressure. The investigators hypothesize that oral steroids will lead to a reduction in lesion size, which will substantially aid in the delivery and incorporation of voice therapy techniques, contributing to the improvement of overall laryngeal biomechanics and providing an ideal starting point for behavioral voice therapy.
- Conditions
- Dysphonia
- Being tested
- Steroid, Lactose Pills
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteroidDrug
Also called Prednizone
A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.
Lactose PillsDietary supplement
4 day course 2 x 20mg per da
| Study group | Role | What they receive |
|---|---|---|
| Steroid | Active comparator | Prednizone pills. 4 day course 2 x 20mg per day. Receives: Drug: Steroid |
| Placebo | Placebo comparator | Lactose Pills. 4 day course 2 x 20mg per day. Receives: Dietary Supplement: Lactose Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months
Data will be collected via measurement of the hatchmark on the 100mm line for each variable (e.g. 72/100). The higher the score, the higher the deviancy. The final score is the average of scores from each variable.
Measured: pre-treatment/baseline to 2 months
Secondary outcomes (3)
Change in Lesion Size From Baseline to 2 Months
Still images of the glottis will be obtained from the video such that the vocal folds are captured in an open position (at least 40 degrees at the anterior commissure). Image J software (NIH) will then be used to outline the lesion and measure the length of the ipsilateral vocal fold.
Measured: pre-treatment/baseline to 2 months
Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months.
A change in VHI scores from pre-treatment to following treatment.
Scores can range from 0-120:
0-30: Mild Minimal amount of handicap 31-60: Moderate Often seen in patients with vocal nodules, polyps, or cysts 60-120: Severe Often seen
Measured: Pre-treatment/baseline to following treatment/2 months
Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milan Amin, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286960
- Sponsor's protocol ID
- 13-00096
- Acronym
- AAO
- Status last verified
- Feb 2020
- First submitted
- 6 Nov 2014
- Last updated
- 12 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
- ClinicalTrials.gov ID
- NCT02286960
- Acronym / sponsor ID
- AAO / 13-00096
- Conditions
- Dysphonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 12 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the considerable use of oral steroids in the regular management of benign vocal fold lesions there is little evidence base in the literature. This study will investigate the efficacy of oral steroids for the treatment of vocal fold lesions in a controlled manner. The specific aim of this study is to determine the effectiveness of of a short course of oral steroids prior to behavioral voice therapy in patients with benign, phonotraumatic vocal fold lesions. Enrolled subjects will be randomized using a random numbers table to either receive oral steroids or no steroids prior to the initiation of voice therapy. The therapist and individuals involved in the collection and analysis of data will be blinded as to whether the subject received drug. Prior to initiation of therapy subjects will be asked to return for an interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation to determine the best mode of therapy they will receive a behavioral voice therapy course, which includes a range of behavioral modifications and motor learning techniques, along with lifestyle measures. In all these phases acoustic and aerodynamic measurements will be collected as well as audio-visual material from the videostroboscopic exams. The investigators hypothesize that oral steroids will lead to a reduction in lesion size, which will substantially aid in the delivery and incorporation of voice therapy techniques, contributing to the improvement of overall laryngeal biomechanics and providing an ideal starting point for behavioral voice therapy.
Detailed description
The study will investigate the potential added advantage of the use of steroids in patients undergoing voice therapy. Enrolled subjects will be randomized using a random numbers table to either receive oral steroids or no steroids prior to the initiation of voice therapy. The therapist and individuals involved in the collection and analysis of data will be blinded as to whether the subject received drug. Prior to initiation of therapy subjects will be asked to return for an interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation to determine the best mode of therapy they will receive a behavioral voice therapy course, which includes a range of behavioral modifications and motor learning techniques, along with lifestyle measures. In all these phases acoustic and aerodynamic measurements will be collected as well as audio-visual material from the videostroboscopic exams. The measurements that will be collected in all these phases are the Voice Handicap Index (VHI)-10 , the noise to harmonic ratio H/N, the fundamental frequency Fo, The transglottic airflow and subglottic pressure. The investigators hypothesize that oral steroids will lead to a reduction in lesion size, which will substantially aid in the delivery and incorporation of voice therapy techniques, contributing to the improvement of overall laryngeal biomechanics and providing an ideal starting point for behavioral voice therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid | Active comparator | Drug: SteroidPrednizone pills. 4 day course 2 x 20mg per day. |
| Placebo | Placebo comparator | Dietary Supplement: Lactose PillsLactose Pills. 4 day course 2 x 20mg per day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 males and females
- Presence of phonotraumatic lesion deemed to be etiologic for the complaint of dysphonia
- Voice therapy deemed to be the primary (or at least initial) treatment to address the dysphonia.
- Willingness to be an active participant in voice therapy.
Key exclusion criteria (11 listed)
- Use of any glucocorticoids (oral, inhaled, or intravenous) within 3 months of the initial evaluation
- Known allergy or hypersensitivity to oral steroids
- Active infection
- Diabetes Mellitus
- Prior history of radiation to the neck
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 |
|---|---|---|
| SteroidAlso: PrednizoneA short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy. | Drug | Steroid |
| Lactose Pills4 day course 2 x 20mg per da | Dietary supplement | Placebo |
Primary outcome
Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months
Time frame: pre-treatment/baseline to 2 months
Data will be collected via measurement of the hatchmark on the 100mm line for each variable (e.g. 72/100). The higher the score, the higher the deviancy. The final score is the average of scores from each variable.
3 secondary outcomes
Change in Lesion Size From Baseline to 2 Months
Time frame: pre-treatment/baseline to 2 months
Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months.
Time frame: Pre-treatment/baseline to following treatment/2 months
Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Milan Amin, 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 Phase 4 study testing Steroid and Lactose Pills 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 4 inclusion and 11 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 12 Mar 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months (time frame: pre-treatment/baseline to 2 months). 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 12 Mar 2020.