- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03458104
Modeling the Effects of Vocal Cord Atrophy on Airflow and Voice Quality in Elderly Individuals
April 3, 2020 updated by: Duke University
- 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 Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Healthy Subjects Cohort:
Inclusion criteria:
- 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)
Exclusion criteria:
- 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:
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vocal Cord Atrophy
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.
|
Cone Beam CT of the larynx
Records and displays real-time sound pressure level intensity, intraoral pressure, airflow rate, and fundamental frequency
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.
|
Active Comparator: Healthy Volunteer
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.
|
Cone Beam CT of the larynx
Records and displays real-time sound pressure level intensity, intraoral pressure, airflow rate, and fundamental frequency
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantify changes in aerodynamic and aeroacoustics patterns in patients with vocal cord atrophy (VCA) before and after voice therapy.
Time Frame: Baseline, 12 weeks
|
before and after treatment changes of aerodynamic and aeroacoustic patterns
|
Baseline, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2018
Primary Completion (Anticipated)
September 1, 2020
Study Completion (Anticipated)
September 1, 2020
Study Registration Dates
First Submitted
February 9, 2018
First Submitted That Met QC Criteria
March 1, 2018
First Posted (Actual)
March 8, 2018
Study Record Updates
Last Update Posted (Actual)
April 7, 2020
Last Update Submitted That Met QC Criteria
April 3, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00076393
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vocal Cord Atrophy
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