DysphagiaNCT02845362
Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases
A study testing Sydney Swallow Questionnaire in people with Dysphagia and Neuromuscular Diseases, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Neuromuscular Diseases
- What is being tested?
- Sydney Swallow Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesBelgium
- Study dates
- Aug 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Phase 1:
- Group 1:
- Healthy participants
- Able to speak, read and write in French
- Aged at least 18 years old
- Group 2:
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Cliniques universitaires Saint Luc
Brussels, 1200
Cliniques universitaires Saint-Luc
Brussels, 1200
About this study
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.
- Conditions
- Dysphagia, Neuromuscular Diseases
- Being tested
- Sydney Swallow Questionnaire
- Keywords
- Neuromuscular, dysphagia, Swallowing disorders, Questionnaire, Assessment
- Medical subject headings
- Deglutition Disorders, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dysphagia assessment | Experimental | Not described Receives: Other: Sydney Swallow Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sydney Swallow Questionnaire
The participants were asked to fill out these questionnaires during the outpatient visit.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Audag, PT, Principal investigator, Cliniques universitaires Saint-Luc, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845362
- Sponsor's protocol ID
- SSQVAL
- Other IDs
- 2016/18MAI/215
- Status last verified
- Apr 2019
- First submitted
- 15 Jul 2016
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the Sydney Swallow Questionnaire in Patients With Neuromuscular Diseases
- ClinicalTrials.gov ID
- NCT02845362
- Acronym / sponsor ID
- SSQVAL
- Conditions
- Dysphagia, Neuromuscular Diseases
- Keywords
- Neuromuscular, dysphagia, Swallowing disorders, Questionnaire, Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dysphagia assessment | Experimental | Other: Sydney Swallow Questionnaire |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy participants
- Able to speak, read and write in French
- Aged at least 18 years old
- 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
Key exclusion criteria (10 listed)
- History of neurological or neuromuscular disease
- History of any diagnosticated swallowing disorder
- Patients who could not be cataloged as dysphagic or non-dysphagic after the videofluoroscopic study evaluation
- Patients unable to answer the questionnaire
- Patients who could not be cataloged as dysphagic or non-dysphagic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sydney Swallow QuestionnaireThe 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. | Other | Dysphagia assessment |
Primary outcome
Sydney Swallow Questionnaire
Time frame: 10 minutes
The participants were asked to fill out these questionnaires during the outpatient visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Dysphagia
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Audag, PT principal investigator
Cliniques universitaires Saint-Luc, Brussels, Belgium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sydney Swallow Questionnaire in people with Dysphagia and Neuromuscular Diseases, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sydney Swallow Questionnaire (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.