SD TT: Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT05158179

Collaborator

(none)

Enrollment

Location

Arm

8.1

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spasmodic Dysphonia Adductor Spasmodic Dysphonia Voice Disorders	Device: Sensation testing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia

Actual Study Start Date :

Aug 27, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spasmodic Dysphonia Patients	Device: Sensation testing Sensation testing tactile aesthesiometer.

Arm

Intervention/Treatment

Experimental: Spasmodic Dysphonia Patients

Device: Sensation testing

Sensation testing tactile aesthesiometer.

Outcome Measures

Primary Outcome Measures

Perceptual strength of sensation on a 1-10 numerical rating scale (NRS) [Immediately after intervention]
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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Voice and Swallowing Center	San Francisco	California	United States	94115

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: Yue Ma, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT05158179

Other Study ID Numbers:

IRB: 20-31653

First Posted:

Dec 15, 2021

Last Update Posted:

Dec 15, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by University of California, San Francisco

throat sensation

Additional relevant MeSH terms:

Dysphonia

Hoarseness

Voice Disorders

Study Results

No Results Posted as of Dec 15, 2021