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

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ClinicalTrials.gov Identifier: NCT02845362
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Dysphagia Neuromuscular Diseases Other: Sydney Swallow Questionnaire Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases
Study Start Date : August 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dysphagia assessment Other: Sydney Swallow Questionnaire
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 Measures :
  1. Sydney Swallow Questionnaire [ Time Frame: 10 minutes ]
    The participants were asked to fill out these questionnaires during the outpatient visit.



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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845362


Locations
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Belgium
Cliniques universitaires Saint Luc
Brussels, Belgium, 1200
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Nicolas Audag, PT Cliniques universitaires Saint-Luc, Brussels, Belgium

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02845362     History of Changes
Other Study ID Numbers: SSQVAL
2016/18MAI/215 ( Other Identifier: CEHF )
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Neuromuscular
dysphagia
Swallowing disorders
Questionnaire
Assessment
Additional relevant MeSH terms:
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Deglutition Disorders
Neuromuscular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases