Voice Disorders Clinical Trial
— SDTTOfficial title:
Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia
Verified date | January 2024 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study investigators have completed a study testing laryngopharyngeal sensation at specific laryngopharyngeal subsites using a novel buckling force aesthesiometer in a series of 22 healthy adults at this institution. Investigators would like to use the same device apparatus to evaluate laryngopharyngeal sensation in patients with laryngopharyngeal disorders, such as adductor spasmodic dysphonia. This study will use a tested laryngopharyngeal aesthesiometer to examine laryngeal sensation using calibrated tactile stimuli to determine differences in somatotopic perceptual strength maps of laryngopharyngeal structures between patients with laryngopharyngeal disorders and healthy controls.
Status | Completed |
Enrollment | 13 |
Est. completion date | April 29, 2022 |
Est. primary completion date | April 29, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Adductor spasmodic dysphonia (can have co-diagnosis of essential tremor) - received Botox injection more than 2 weeks ago Exclusion Criteria: - excessive gagging - active smoker - non-Botox responsive - abductor spasmodic dysphonia exclusively - essential tremor diagnosis exclusively |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Voice and Swallowing Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Spasmodic Dysphonia Association |
United States,
Aviv JE, Martin JH, Keen MS, Debell M, Blitzer A. Air pulse quantification of supraglottic and pharyngeal sensation: a new technique. Ann Otol Rhinol Laryngol. 1993 Oct;102(10):777-80. doi: 10.1177/000348949310201007. — View Citation
Aviv JE, Martin JH, Kim T, Sacco RL, Thomson JE, Diamond B, Close LG. Laryngopharyngeal sensory discrimination testing and the laryngeal adductor reflex. Ann Otol Rhinol Laryngol. 1999 Aug;108(8):725-30. doi: 10.1177/000348949910800802. — View Citation
Bearelly S, Cheung SW. Sensory Topography of Oral Structures. JAMA Otolaryngol Head Neck Surg. 2017 Jan 1;143(1):73-80. doi: 10.1001/jamaoto.2016.2772. — View Citation
Bearelly S, Wang SJ, Cheung SW. Oral sensory dysfunction following radiotherapy. Laryngoscope. 2017 Oct;127(10):2282-2286. doi: 10.1002/lary.26591. Epub 2017 Apr 11. — View Citation
Strohl MP, Young VN, Dwyer CD, Bhutada A, Crawford E, Chang JL, Rosen CA, Cheung SW. Novel Adaptation of a Validated Tactile Aesthesiometer to Evaluate Laryngopharyngeal Sensation. Laryngoscope. 2021 Jun;131(6):1324-1331. doi: 10.1002/lary.28947. Epub 2020 Jul 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Laryngeal Adductor Reflex | The outcome measure is the presence or absence of a laryngeal adductor reflex (LAR) which is the reflexive, involuntary closure of the vocal folds in response to stimulation, as seen on flexible laryngoscopy. This is a binary finding in that this is immediately observed as either being present or absent following direct contact by the tactile esthesiometer device. Accordingly, there are no units of measure. The presence or absence of the LAR was noted at the time of testing by the study team and confirmed on subsequent video review by another member of the study team. This study only examined patients with SD - all of whom were found to have LAR present. | Immediately after intervention, less than 10 seconds | |
Secondary | Perceptual Strength of Sensation on a 1-10 Numerical Rating Scale (NRS) | The smallest size tactile aesthesiometer was utilized to establish an internal anchor base score of 1 based on direct palpation of the posterior nasopharyngeal wall. Participants were instructed to rate all subsequent perceptual strength testings in comparison to this individualized, internal anchor. During testing, participants were instructed to raise their hand when the stimulus was detected, and then were asked by the study team to report a perceptual strength "score" from 1-10, in comparison to the nasopharyngeal anchor strength of 1, with 1 being the same as the barest perception of touch within the nasopharynx and 10 being 10-fold stronger sensation. It was not anticipated that any perceived sensation within the larynx (a more sensitive organ than the nasopharynx) would be lower than the lowest perceived sensation in the nose. | Immediately after intervention, within 30 seconds |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04096352 -
Virtual Reality in Teachers' Vocal Motor Behavior Acquisition (VirtuVox)
|
N/A | |
Completed |
NCT01196611 -
Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders
|
N/A | |
Recruiting |
NCT04584658 -
Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
|
||
Not yet recruiting |
NCT05970562 -
Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction
|
Early Phase 1 | |
Recruiting |
NCT04846413 -
Voice Analysis in Patients With Neurologic Diseases
|
||
Completed |
NCT06137131 -
Voice Therapy With a Semi-occluded Vocal Tract
|
N/A | |
Completed |
NCT01435837 -
Interaction of Caffeine and Hydration on Voice
|
Phase 0 | |
Recruiting |
NCT05158166 -
DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia
|
Phase 1/Phase 2 | |
Completed |
NCT04002336 -
Testing a Smart Phone App to Enhance Voice Therapy Adherence
|
N/A | |
Recruiting |
NCT05357222 -
Straw Phonation Exercise Program for Pitch Extension
|
N/A | |
Not yet recruiting |
NCT04513392 -
Comparison of BL and KTP Laser for Treatment of Benign Vocal Fold Lesions
|
N/A | |
Not yet recruiting |
NCT05348031 -
Multimodal Analysis of Structural Voice Disorders Based on Speech and Stroboscopic Laryngoscope Video
|
||
Completed |
NCT02441348 -
Efficacy of Conversation Training Therapy (CTT)
|
||
Completed |
NCT00055549 -
Dextromethorphan to Treat Patients With Voice Spasms
|
Phase 1 | |
Completed |
NCT01131494 -
Swallowing Training in Parkinson`s Disease
|
N/A | |
Completed |
NCT05187910 -
Correlation Between Montreal Cognitive Assessment and Voice Therapy Outcomes in the Aging Treatment- Seeking Population
|
N/A | |
Completed |
NCT01625728 -
Vocal Demands Among Classroom Teachers
|
||
Completed |
NCT02102399 -
Vocal Warm-up and Respiratory Muscle Training
|
N/A | |
Completed |
NCT00961818 -
Immediate Effect Analysis of Vocal Techniques
|
N/A | |
Completed |
NCT04966689 -
The Effect of Combined Speech and Music-therapy on the Speech Characteristics of People With Parkinson's Disease (PD)
|
N/A |