Back to results

Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases

Primary Purpose

Dysphagia, Neuromuscular Diseases

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Sydney Swallow Questionnaire

About this trial

This is an interventional screening trial for Dysphagia focused on measuring Neuromuscular, dysphagia, Swallowing disorders, Questionnaire, Assessment

Eligibility Criteria

undefined - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Phase 1:

Group 1:

Healthy participants
Able to speak, read and write in French
Aged at least 18 years old

Group 2:

Patients, with symptoms indicative of a deglutition disorder, referred for a videofluoroscopic study to the Otolaryngology, Head and Neck Surgery Department, Voice and Swallowing Clinic
Able to speak, read and write in French
Aged at least 18 years old

Phase 2:

Clinical diagnosis of neuromuscular diseases
Able to understand French

Exclusion Criteria:

Phase 1:

Group 1:

History of neurological or neuromuscular disease
History of any diagnosticated swallowing disorder

Group 2:

Patients who could not be cataloged as dysphagic or non-dysphagic after the videofluoroscopic study evaluation
Patients unable to answer the questionnaire

Phase 2:

Patients who could not be cataloged as dysphagic or non-dysphagic
Patients unable to answer the questionnaire

Sites / Locations

Cliniques universitaires Saint Luc
Cliniques universitaires Saint-Luc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dysphagia assessment

Arm Description

Outcomes

Primary Outcome Measures

Sydney Swallow Questionnaire

The participants were asked to fill out these questionnaires during the outpatient visit.

Secondary Outcome Measures

Full Information

NCT ID

NCT02845362

First Posted

July 15, 2016

Last Updated

April 11, 2019

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT02845362

Brief Title

Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases

Official Title

Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

August 2016 (undefined)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Measurements of dysphagia severity are important when making management decisions and in the objective evaluation of swallowing impairments. The Sydney Swallow Questionnaire (SSQ) is a validated self-report inventory using a visual analogue scale. This questionnaire permits a quantitative, sensitive, specific, repeatable and easily responsive evaluation of dysphagia in different pathology. Opposed to largely used videofluoroscopy swallowing study and endoscopy examinations, the SSQ is noninvasive, less expensive, avoids radiation exposure and enables a readily available assessment. Validated French version is not yet available. In the first phase of the study the investigators will validated this translation in dysphagic patients and control. Secondly, the investigators will validate the SSQ in Neuromuscular patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysphagia, Neuromuscular Diseases

Keywords

Neuromuscular, dysphagia, Swallowing disorders, Questionnaire, Assessment

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dysphagia assessment

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Sydney Swallow Questionnaire

Intervention Description

The Sydney Swallow Questionnaire (SSQ) is a validated self-report symptom questionnaire, it contains 17 items recorded as visual analogue scales and is a tool specifically designed for evaluation of swallowing difficulties.

Primary Outcome Measure Information:

Title

Sydney Swallow Questionnaire

Description

The participants were asked to fill out these questionnaires during the outpatient visit.

Time Frame

10 minutes

10. Eligibility

Sex

All

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Phase 1: Group 1: Healthy participants Able to speak, read and write in French Aged at least 18 years old Group 2: Patients, with symptoms indicative of a deglutition disorder, referred for a videofluoroscopic study to the Otolaryngology, Head and Neck Surgery Department, Voice and Swallowing Clinic Able to speak, read and write in French Aged at least 18 years old Phase 2: Clinical diagnosis of neuromuscular diseases Able to understand French Exclusion Criteria: Phase 1: Group 1: History of neurological or neuromuscular disease History of any diagnosticated swallowing disorder Group 2: Patients who could not be cataloged as dysphagic or non-dysphagic after the videofluoroscopic study evaluation Patients unable to answer the questionnaire Phase 2: Patients who could not be cataloged as dysphagic or non-dysphagic Patients unable to answer the questionnaire

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Audag, PT

Organizational Affiliation

Cliniques universitaires Saint-Luc, Brussels, Belgium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cliniques universitaires Saint Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Cliniques universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases

We'll reach out to this number within 24 hrs