Trial Outcomes & Findings for Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia (NCT NCT05158179)
NCT ID: NCT05158179
Last Updated: 2024-01-11
Results Overview
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.
COMPLETED
NA
13 participants
Immediately after intervention, less than 10 seconds
2024-01-11
Participant Flow
Participant milestones
| Measure |
Spasmodic Dysphonia Patients
Patients with Spasmodic Dysphonia underwent one-time testing of laryngeal sensation using a validated methodology involving a tactile esthesiometer. Various sizes of monofilament device were passed through the working channel of a flexible laryngoscope passed through the nose under local anesthesia. This study involved SD patients to then be compared to historical controls already assessed previously at our institution.
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|---|---|
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Overall Study
STARTED
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13
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Spasmodic Dysphonia Patients
n=13 Participants
Sensation testing of Spasmodic Dysphonia Patients
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Age, Continuous
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60 years
STANDARD_DEVIATION 15.2 • n=13 Participants
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Sex: Female, Male
Female
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9 Participants
n=13 Participants
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Sex: Female, Male
Male
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4 Participants
n=13 Participants
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Region of Enrollment
United States
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13 participants
n=13 Participants
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Voice Handicap Index-10 (VHI-10)
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24 units on a scale
STANDARD_DEVIATION 9.4 • n=13 Participants
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PRIMARY outcome
Timeframe: Immediately after intervention, less than 10 secondsThe 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.
Outcome measures
| Measure |
Spasmodic Dysphonia Patients
n=13 Participants
Sensation testing of Spasmodic Dysphonia Patients
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|---|---|
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Laryngeal Adductor Reflex
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13 Participants
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SECONDARY outcome
Timeframe: Immediately after intervention, within 30 secondsThe 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.
Outcome measures
| Measure |
Spasmodic Dysphonia Patients
n=13 Participants
Sensation testing of Spasmodic Dysphonia Patients
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|---|---|
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Perceptual Strength of Sensation on a 1-10 Numerical Rating Scale (NRS)
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4.6 units on a scale
Standard Deviation 2.8
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Adverse Events
Spasmodic Dysphonia Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place