DysphagiaNCT01965964
Translation of the Sydney Swallow Questionnaire and Validation of the German Version
An observational study of Dysphagia, run by University of Zurich at 1 site in Switzerland.
Trial summary
Translation of a validated questionnaire (SSQ) from english to german and validation of the german version. The SSQ consists of 17 well-structured questions for the assessment and quantification of patient reported difficulties in swallowing function. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- Questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Dec 2013
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from Dysphagia for at least half a year
Inclusion criteria: - patients with diagnosed dysphagia "of any causes"
- sufficient proficiency in german
- voluntary participation
Exclusion criteria: - insufficient knowledge of the german language
- cognitive limitations
- reduced general state of health
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Otorhinolaryngology
Zurich, Canton of Zurich, 8091
About this study
Official title: Sydney Swallow Questionnaire: Translation of a Questionnaire Relating to the Function of Swallowing and Validation of the German Version
Translation of a validated questionnaire (SSQ) from english to german and validation of the german version. The SSQ consists of 17 well-structured questions for the assessment and quantification of patient reported difficulties in swallowing function. The tool is specifically designed to evaluate important aspects of swallowing function The questions cover the symptoms related to combinations of variables like the anatomic region, type of dysfunction, and the consistency of swallowed bolus.
- Conditions
- Dysphagia
- Being tested
- Questionnaire
- Keywords
- Dysphagia, Swallowing functions, Questionnaire in German
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients able to understand and fill out the german translation of the questionnaire
Establishment of a questionnaire in german to determine patients' swallowing functions.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionDec 2013
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 University of ZurichThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joerg E Bohlender, MD, Principal investigator, University Hospital Zurich, Division of Otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965964
- Sponsor's protocol ID
- BJ_05_07_2011
- Status last verified
- Dec 2015
- First submitted
- 15 Oct 2013
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sydney Swallow Questionnaire: Translation of a Questionnaire Relating to the Function of Swallowing and Validation of the German Version
- ClinicalTrials.gov ID
- NCT01965964
- Acronym / sponsor ID
- BJ_05_07_2011
- Conditions
- Dysphagia
- Keywords
- Dysphagia, Swallowing functions, Questionnaire in German
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Oct 2013 (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.
Translation of a validated questionnaire (SSQ) from english to german and validation of the german version. The SSQ consists of 17 well-structured questions for the assessment and quantification of patient reported difficulties in swallowing function. The tool is specifically designed to evaluate important aspects of swallowing function The questions cover the symptoms related to combinations of variables like the anatomic region, type of dysfunction, and the consistency of swallowed bolus.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from Dysphagia for at least half a year
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 |
|---|---|---|
| Questionnaire | Procedure or surgery | – |
Primary outcome
Percentage of patients able to understand and fill out the german translation of the questionnaire
Time frame: Baseline
Establishment of a questionnaire in german to determine patients' swallowing functions.
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 15 Dec 2015.
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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.
Joerg E Bohlender, MD principal investigator
University Hospital Zurich, Division of Otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Percentage of patients able to understand and fill out the german translation of the questionnaire (time frame: Baseline). 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 15 Dec 2015.