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Perceptual Assessment of the Tracheoesophageal Voice

Primary Purpose

Tracheo-Esophageal Fistula Following Tracheostomy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
perceptual assessment of the recorded voice sample
voice recording
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tracheo-Esophageal Fistula Following Tracheostomy focused on measuring voice prosthesis, perceptual evaluation

Eligibility Criteria

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

Inclusion Criteria: native Italian speakers; ability to produce TE voice. Exclusion Criteria: reading difficulties; presence or suspicion of disease recurrence; other communication problems not related to Total laryngectomy.

Sites / Locations

  • Fondazione Policlinico Universitario A. Gemelli - IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

laryngectomized patients

health professionals

Arm Description

Outcomes

Primary Outcome Measures

Reliability
The primary aim of this study was to carry out a psychometric validation in Italian of a perceptual evaluation scale for use by clinicians. The intra- and inter-rater reliability of each parameter was analyzed with Cohen's kappa weighted quadratic statistic. A weighted average kappa coefficient equal to or greater than 0.61 has been considered a "good" level of agreement.

Secondary Outcome Measures

Training
Secondary aim was to investigate whether the SToPS could be used without training, using written guidelines only and focusing on the effect of experience on the administration of the SToPS. For this reason, the reliability results obtained were compared with those of the original study.

Full Information

First Posted
February 13, 2023
Last Updated
March 3, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05754671
Brief Title
Perceptual Assessment of the Tracheoesophageal Voice
Official Title
PERCEPTUAL EVALUATION OF THE TRACHEO-OESOPHAGEAL VOICE: ITALIAN VALIDATION OF THE SUNDERLAND TRACHEOESOPHAGEAL PERCEPTUAL SCALE (I-SToPS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
April 4, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aim of this study was to validate the Sunderland Tracheoesophageal Perceptual Scale (SToPS) in Italian language by checking the inter- and intra-rater reliability. The validation of the tool involved the following steps: 1) Translation and adaptation of the SToPS into Italian language; 2) Recruitment of participants (43 laryngectomized patients with a voice prosthesis and 12 health professionals - 6 speech and language therapists (SLTs) and 6 Ear, Nose, and Throat (ENTs) surgeons - classified into experienced or not at assessing voice; 3) Recording of patients' speech samples; 4) Perceptual evaluation of recorded speech samples (test and re-test) performed by the 12 health professionals; 5) Statistical analysis (quadratic weighted Cohen Kappa and weighted Kappa of Light coefficients). SLTs with specific experience in tracheo-esophageal and laryngeal voice rated more reliably than the others raters. For all groups of raters, the inter-rater agreement was worse than the intra-rater one for 9/10 parameters. Exclusively for experienced SLTs, only the "Impairment of social acceptability" parameter reached a good level of inter-rater agreement. In conclusion, the Italian version of SToPS can be considered a reliable tool. As in the original version, expert SLTs may be considered the optimal judges for tracheoesophageal voice assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheo-Esophageal Fistula Following Tracheostomy
Keywords
voice prosthesis, perceptual evaluation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laryngectomized patients
Arm Type
Experimental
Arm Title
health professionals
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
perceptual assessment of the recorded voice sample
Intervention Description
perceptual assessment of the recorded voice samples
Intervention Type
Other
Intervention Name(s)
voice recording
Intervention Description
voice recording
Primary Outcome Measure Information:
Title
Reliability
Description
The primary aim of this study was to carry out a psychometric validation in Italian of a perceptual evaluation scale for use by clinicians. The intra- and inter-rater reliability of each parameter was analyzed with Cohen's kappa weighted quadratic statistic. A weighted average kappa coefficient equal to or greater than 0.61 has been considered a "good" level of agreement.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Training
Description
Secondary aim was to investigate whether the SToPS could be used without training, using written guidelines only and focusing on the effect of experience on the administration of the SToPS. For this reason, the reliability results obtained were compared with those of the original study.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: native Italian speakers; ability to produce TE voice. Exclusion Criteria: reading difficulties; presence or suspicion of disease recurrence; other communication problems not related to Total laryngectomy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucia D'Alatri, MD
Organizational Affiliation
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli - IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Perceptual Assessment of the Tracheoesophageal Voice

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