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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

Tracking Information
First Submitted Date  ICMJE July 15, 2016
First Posted Date  ICMJE July 27, 2016
Last Update Posted Date April 12, 2019
Study Start Date  ICMJE August 2016
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
Sydney Swallow Questionnaire [ Time Frame: 10 minutes ]
The participants were asked to fill out these questionnaires during the outpatient visit.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02845362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases
Official Title  ICMJE Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Dysphagia
  • Neuromuscular Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Dysphagia assessment
Intervention: Other: Sydney Swallow Questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2016)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02845362
Other Study ID Numbers  ICMJE SSQVAL
2016/18MAI/215 ( Other Identifier: CEHF )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicolas Audag, PT Cliniques universitaires Saint-Luc, Brussels, Belgium
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP