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Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia (SD TT)

Primary Purpose

Spasmodic Dysphonia, Adductor Spasmodic Dysphonia, Voice Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensation testing
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasmodic Dysphonia focused on measuring throat sensation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Voice and Swallowing Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spasmodic Dysphonia Patients

Arm Description

Outcomes

Primary Outcome Measures

Perceptual strength of sensation on a 1-10 numerical rating scale (NRS)
The outcome measure is the difference in perceptual strength rating between patients with laryngopharyngeal disorders and healthy controls. Patients will report the amount of sensation felt on a verbal scale from 1-10. This is done in relation to sensation in the nasopharynx described as a "1".

Secondary Outcome Measures

Full Information

First Posted
November 18, 2021
Last Updated
January 3, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05158179
Brief Title
Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia
Acronym
SD TT
Official Title
Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
April 29, 2022 (Actual)
Study Completion Date
April 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasmodic Dysphonia, Adductor Spasmodic Dysphonia, Voice Disorders
Keywords
throat sensation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cottonoid pledgets soaked in 4% lidocaine and neo-synephrine will be placed on this side. The pledgets will be kept in place for 5 minutes to allow adequate decongestion and anesthetization. The aesthesiometer will be placed through the 2.0 mm working channel of the Olympus Corporation (Tokyo, Japan) ENF-VT2 channeled flexible video rhinolaryngoscope with a 4.9 mm outer diameter. The flexible laryngoscope and aesthesiometer assembly will then be advanced into the pharynx and positioned for target testing. The operator field of view will be adjusted in the craniocaudal axis to optimize visualization of the stimulation target, monofilament tip, and both vocal folds to assess for a stimulation evoked LAR response. The monofilament will then be advanced to within several mm of the target laryngopharyngeal subsite and subsequently applied orthogonally until it buckled by 10-30%, followed by quick retraction to assess for triggering of the rapid LAR response.
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spasmodic Dysphonia Patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Sensation testing
Intervention Description
Sensation testing tactile aesthesiometer.
Primary Outcome Measure Information:
Title
Perceptual strength of sensation on a 1-10 numerical rating scale (NRS)
Description
The outcome measure is the difference in perceptual strength rating between patients with laryngopharyngeal disorders and healthy controls. Patients will report the amount of sensation felt on a verbal scale from 1-10. This is done in relation to sensation in the nasopharynx described as a "1".
Time Frame
Immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Ma, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Voice and Swallowing Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27684535
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.
Results Reference
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PubMed Identifier
28397276
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.
Results Reference
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PubMed Identifier
8215097
Citation
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.
Results Reference
background
PubMed Identifier
10453777
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.
Results Reference
background
PubMed Identifier
32735711
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.
Results Reference
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Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia

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