WithdrawnNCT03458104Updated Apr 7, 2020

Modeling the Effects of Vocal Cord Atrophy on Airflow and Voice Quality in Elderly Individuals

An interventional study of Cone Beam Computed Tomography and Acoustic/Auerodynamic testing in Vocal Cord Atrophy, sponsored by Duke University. Withdrawn at 1 site in United States. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-07.

Sponsored by Duke University · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn

Recruitment logistics

Phase: Not applicable
Study type: Interventional
Enrollment: 0
Allocation: Non-randomized
Ages: 65 Years to 80 Years
Sex: All

Study summary

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 studied

Vocal Cord Atrophy

Browse trials for

Atrophy 830

Who can participate

Ages eligible: 65 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

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 design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

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.
Other: Cone Beam Computed Tomography · Diagnostic Test: Acoustic/Auerodynamic testing · Diagnostic Test: Laryngovideostroboscopy
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.
Other: Cone Beam Computed Tomography · Diagnostic Test: Acoustic/Auerodynamic testing · Diagnostic Test: Laryngovideostroboscopy

Interventions

OtherCone Beam Computed Tomography
Cone Beam CT of the larynx
Diagnostic testAcoustic/Auerodynamic testing
Records and displays real-time sound pressure level intensity, intraoral pressure, airflow rate, and fundamental frequency
Diagnostic testLaryngovideostroboscopy
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 researchers measure

Primary outcomes

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
Time frame: Baseline, 12 weeks

Secondary outcomes

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
Time frame: Baseline, 12 weeks

Study locations

1 site

Duke University Medical Center
Durham, North Carolina 27710, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03458104
Lead sponsor: Duke University
Responsible party: Sponsor
First posted: Mar 8, 2018
Start date: Mar 28, 2018
Primary completion: Sep 2020 (estimated)
Completion: Sep 2020 (estimated)
Last update: Apr 7, 2020

Study contacts

Dennis Frank-Ito, PhD

principal investigator · Duke University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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