Vocal Cord AtrophyNCT03458104
Modeling the Effects of Vocal Cord Atrophy on Airflow and Voice Quality in Elderly Individuals
A study testing Cone Beam Computed Tomography, Acoustic/Auerodynamic testing and Laryngovideostroboscopy in people with Vocal Cord Atrophy, run by Duke University at 1 site in United States.
Trial summary
1. The purpose of this study is to develop a validated computational model for assessing normative change in these patterns in patients with vocal cord atrophy before and after voice therapy. 2. This is a prospective study comparing two cohorts - patients with vocal cord atrophy(VCA) (G1) and healthy controls (G2). Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vocal Cord Atrophy
- What is being tested?
- Cone Beam Computed Tomography, Acoustic/Auerodynamic testing and Laryngovideostroboscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to Sep 2020
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Between 65 and 80 years of age
- Voice Handicap Index (VHI) questionnaire score of less than 10.
- Little or no dysphonia as assessed by a speech language pathologist from the Duke Voice Care Center
- No contraindications to have a CBCT scan (as assessed per standard clinical practice)
- Between 65 and 80 years of age
- Clinical diagnosis of vocal cord atrophy (VCA)
- Treated for the above condition by a provider at the Duke Head and Neck Surgery \& Communication Sciences Clinic
- Elected to undergo voice therapy as standard of care for treatment of VCA
Who cannot join
- Inability to speak, read, write, and understand English
- Inability to provide written consent
- Self-reported or known allergy to Afrin or Tetracaine HCL (or related class of drugs) and unable or willing to complete the laryngovideostroboscopy procedure with it.
- Vocal Cord Atrophy Cohort:
- Other conditions that affect the voice and would interfere with study measures, as determined by PI
- Inability to speak, read, write, and understand English
- Inability to provide written consent
- Self-reported or known allergy to Afrin or Tetracaine HCL (or related class of drugs) and unable or willing to complete the laryngovideostroboscopy procedure with it.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
- The purpose of this study is to develop a validated computational model for assessing normative change in these patterns in patients with vocal cord atrophy before and after voice therapy.
- This is a prospective study comparing two cohorts - patients with vocal cord atrophy(VCA) (G1) and healthy controls (G2). Subjects with VCA will receive a cone beam computed tomography (CBCT) scan with the standard laryngeal protocol before and after voice therapy. Healthy controls will also receive one cone beam computed tomography (CBCT) scan. Subjects with VCA (G1) will undergo post-therapy scans approximately 4 weeks after completion of voice therapy treatment. Enrolled subjects will also undergo a video stroboscopy and acoustic/aerodynamic testing. Subjects in G1 typically have these procedures performed before and after voice therapy as standard of care. Participants in G2 (healthy controls) will have the video stroboscopy and acoustic/aerodynamic testing just once since they would not otherwise be scheduled to undergo voice therapy. Potential subjects will be between 65 and 80 years of age will be considered for the study if they qualify based on inclusion criteria. Potential subjects will undergo are pre-screening process involving an initial telephone screening.
- Raw data (measured and calculated) derived from this pilot study will be reported, and no statistical analysis will be performed. Data from specific aim 1 (G2) and specific aim 2 (G1) will be compared using graphical representations such as bar and dot plots. There is a potential for the loss of confidentiality; however, every reasonable effort will be made to limit breaches of privacy and confidentiality. Subjects may directly benefit from this study. In addition, data and conclusions derived from this study may help future patients regarding the effects of vocal therapy on vocal cord atrophy (VCA).
The investigators will recruit up to 12 subjects to account for screen failures. Once 8 eligible subjects are enrolled (4 per group), then enrollment will end.
- Conditions
- Vocal Cord Atrophy
- Being tested
- Cone Beam Computed Tomography, Acoustic/Auerodynamic testing, Laryngovideostroboscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam Computed TomographyOther
Cone Beam CT of the larynx
Acoustic/Auerodynamic testingDiagnostic test
Records and displays real-time sound pressure level intensity, intraoral pressure, airflow rate, and fundamental frequency
LaryngovideostroboscopyDiagnostic test
Visualization of vocal cords in slow motion. It uses a stroboscopic lamp, which generates regular flashes of light. A flexible tube is inserted in the back of the mouth or through the nose and into the throat. Video pictures are then recorded while patients are making sound.
| Study group | Role | What they receive |
|---|---|---|
| Vocal Cord Atrophy | Experimental | Quantify changes in aerodynamic and aeroacoustics patterns in patients with vocal cord atrophy (VCA) before and after voice therapy. To evaluate changes, subjects will have Laryngovideostroboscopy, Acoustic/Auerodynamic testing, and Cone Beam CT scans of the larynx before and after voice therapy. Receives: Other: Cone Beam Computed Tomography; Diagnostic Test: Acoustic/Auerodynamic testing; Diagnostic Test: Laryngovideostroboscopy |
| Healthy Volunteer | Active comparator | Develop a validated computational model for assessing normative laryngeal aerodynamic and aeroacoustic patterns in healthy elderly individuals. To assess normal laryngeal aerodynamic and aeroacoustic patterns in this cohort, subjects will subjects will have Laryngovideostroboscopy, Acoustic/Auerodynamic testing, and Cone Beam CT scans of the larynx. Receives: Other: Cone Beam Computed Tomography; Diagnostic Test: Acoustic/Auerodynamic testing; Diagnostic Test: Laryngovideostroboscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acoustic/aerodynamic quantities as measured by the Phonatory Aerodynamic System
Composite score of vital capacity, mean airflow rate, laryngeal airway resistance, maximum phonation duration, sound pressure level, frequency, aerodynamci dfficiency
Measured: Baseline, 12 weeks
Secondary outcomes (1)
Quantify changes in aerodynamic and aeroacoustics patterns in patients with vocal cord atrophy (VCA) before and after voice therapy.
before and after treatment changes of aerodynamic and aeroacoustic patterns
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start28 Mar 2018
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Recruitment logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord AtrophyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Frank-Ito, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458104
- Sponsor's protocol ID
- Pro00076393
- Status last verified
- Apr 2020
- First submitted
- 9 Feb 2018
- Last updated
- 7 Apr 2020
- 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 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling the Effects of Vocal Cord Atrophy on Airflow and Voice Quality in Elderly Individuals
- ClinicalTrials.gov ID
- NCT03458104
- Acronym / sponsor ID
- Pro00076393
- Conditions
- Vocal Cord Atrophy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment logistics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 8 Mar 2018 (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 develop a validated computational model for assessing normative change in these patterns in patients with vocal cord atrophy before and after voice therapy.
- This is a prospective study comparing two cohorts - patients with vocal cord atrophy(VCA) (G1) and healthy controls (G2). Subjects with VCA will receive a cone beam computed tomography (CBCT) scan with the standard laryngeal protocol before and after voice therapy. Healthy controls will also receive one cone beam computed tomography (CBCT) scan. Subjects with VCA (G1) will undergo post-therapy scans approximately 4 weeks after completion of voice therapy treatment. Enrolled subjects will also undergo a video stroboscopy and acoustic/aerodynamic testing. Subjects in G1 typically have these procedures performed before and after voice therapy as standard of care. Participants in G2 (healthy controls) will have the video stroboscopy and acoustic/aerodynamic testing just once since they would not otherwise be scheduled to undergo voice therapy. Potential subjects will be between 65 and 80 years of age will be considered for the study if they qualify based on inclusion criteria. Potential subjects will undergo are pre-screening process involving an initial telephone screening.
- Raw data (measured and calculated) derived from this pilot study will be reported, and no statistical analysis will be performed. Data from specific aim 1 (G2) and specific aim 2 (G1) will be compared using graphical representations such as bar and dot plots. There is a potential for the loss of confidentiality; however, every reasonable effort will be made to limit breaches of privacy and confidentiality. Subjects may directly benefit from this study. In addition, data and conclusions derived from this study may help future patients regarding the effects of vocal therapy on vocal cord atrophy (VCA).
The investigators will recruit up to 12 subjects to account for screen failures. Once 8 eligible subjects are enrolled (4 per group), then enrollment will end.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vocal Cord Atrophy | Experimental | Other: Cone Beam Computed Tomography, Diagnostic Test: Acoustic/Auerodynamic testing, Diagnostic Test: LaryngovideostroboscopyQuantify changes in aerodynamic and aeroacoustics patterns in patients with vocal cord atrophy (VCA) before and after voice therapy. To evaluate changes, subjects will have Laryngovideostroboscopy, Acoustic/Auerodynamic testing, and Cone Beam CT scans of the larynx before and after voice therapy. |
| Healthy Volunteer | Active comparator | Other: Cone Beam Computed Tomography, Diagnostic Test: Acoustic/Auerodynamic testing, Diagnostic Test: LaryngovideostroboscopyDevelop a validated computational model for assessing normative laryngeal aerodynamic and aeroacoustic patterns in healthy elderly individuals. To assess normal laryngeal aerodynamic and aeroacoustic patterns in this cohort, subjects will subjects will have Laryngovideostroboscopy, Acoustic/Auerodynamic testing, and Cone Beam CT scans of the larynx. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Between 65 and 80 years of age
- Voice Handicap Index (VHI) questionnaire score of less than 10.
- Little or no dysphonia as assessed by a speech language pathologist from the Duke Voice Care Center
- No contraindications to have a CBCT scan (as assessed per standard clinical practice)
- Between 65 and 80 years of age
Key exclusion criteria (8 listed)
- Inability to speak, read, write, and understand English
- Inability to provide written consent
- Self-reported or known allergy to Afrin or Tetracaine HCL (or related class of drugs) and unable or willing to complete the laryngovideostroboscopy procedure with it.
- Other conditions that affect the voice and would interfere with study measures, as determined by PI
- Inability to speak, read, write, and understand English
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 |
|---|---|---|
| Cone Beam Computed TomographyCone Beam CT of the larynx | Other | Healthy Volunteer, Vocal Cord Atrophy |
| Acoustic/Auerodynamic testingRecords and displays real-time sound pressure level intensity, intraoral pressure, airflow rate, and fundamental frequency | Diagnostic test | Healthy Volunteer, Vocal Cord Atrophy |
| LaryngovideostroboscopyVisualization of vocal cords in slow motion. It uses a stroboscopic lamp, which generates regular flashes of light. A flexible tube is inserted in the back of the mouth or through the nose and into the throat. Video pictures are then recorded while patients are making sound. | Diagnostic test | Healthy Volunteer, Vocal Cord Atrophy |
Primary outcome
Change in acoustic/aerodynamic quantities as measured by the Phonatory Aerodynamic System
Time frame: Baseline, 12 weeks
Composite score of vital capacity, mean airflow rate, laryngeal airway resistance, maximum phonation duration, sound pressure level, frequency, aerodynamci dfficiency
1 secondary outcome
Quantify changes in aerodynamic and aeroacoustics patterns in patients with vocal cord atrophy (VCA) before and after voice therapy.
Time frame: Baseline, 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
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Vocal Fold Injection by Platelet Rich Plasma
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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.
Dennis Frank-Ito, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone Beam Computed Tomography, Acoustic/Auerodynamic testing and Laryngovideostroboscopy in people with Vocal Cord Atrophy, run by Duke University 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 8 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: withdrawn, as of the sponsor's last update on 7 Apr 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. 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 withdrawn before enrolling participants, so there are no results.
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 acoustic/aerodynamic quantities as measured by the Phonatory Aerodynamic System (time frame: Baseline, 12 weeks). 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 7 Apr 2020.