NCT02845362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

July 15, 2016

Last Update Submit

April 11, 2019

Conditions

DysphagiaNeuromuscular Diseases

Keywords

NeuromusculardysphagiaSwallowing disordersQuestionnaireAssessment

Outcome Measures

Primary Outcomes (1)

  • Sydney Swallow Questionnaire

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

    10 minutes

Study Arms (1)

Dysphagia assessment

EXPERIMENTAL
Other: Sydney Swallow Questionnaire

Interventions

Sydney Swallow QuestionnaireOTHER

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.

Dysphagia assessment

Eligibility Criteria

AgeUp to 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Deglutition DisordersNeuromuscular Diseases

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesNervous System Diseases

Study Officials

  • Nicolas Audag, PT

    Cliniques universitaires Saint-Luc, Brussels, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 27, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2018

Study Completion

October 1, 2018

Last Updated

April 12, 2019

Record last verified: 2019-04

Locations

BE(2)