Dysphagia, OropharyngealNCT04465903

Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire

An observational study of Dysphagia, Oropharyngeal and Swallowing Disorder, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Dysphagia, Oropharyngeal, Swallowing Disorder, Validation
What is being tested?: Turkish Version of Sydney Swallow Questionnaire
How many people: 170 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 30 Jul 2020to 30 Oct 2020
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Adults with oropharyngeal dysphagia and healthy adults

Who may be able to join

Group 1:
Able to speak, read, understand and write in Turkish
History of dysphagia during 6 months
Age between 18-80 years
Group 2:
Able to speak, read, understand and write in Turkish
Healthy adults
Age between 18-80 years old.

Who cannot join

Mental disorders
Cognitive limitations
Able not to speak, read, understand and write in Turkish
Underwent any surgery last a month
Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy
Pregnancy
Malignancies
Out of age 18-80 years old.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Prof Dr Cemil Tascioglu City Hospital
Istanbul, 34384

Other trials in Turkey (Türkiye)

About this study

Official title: Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire (SSQ-T)

Purpose of the study is the validity and reliability of the Turkish version of the Sydney Swallow Questionnaire (SSQ-T), so that it would be used as an assessment tool for Turkish dysphagia patients. Despite being translated and validated in many languages, there is no validated Turkish version of SSQ to measure the severity of oropharyngeal dysphagia.

Read the detailed description

The swallow function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as fibreoptic endoscopic evaluation of swallowing (FEES), videofluoroscopy, or well structured questionnaires. There are many questionnaire and scales for assessment of swallow but very few have been validated. The study will assess the construct validity and reliability of the Turkish version of Self-report Symptom Inventory as known as Sydney Swallow Questionnaire. The investigators developed the Turkish version of this questionnaire (SSQ-T), according to the cross-cultural adaptation guidelines. Two translators translated the SSQ into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The SSQ questionnaire consisted of 17 basic questions related with dysphagia symptoms.

Conditions: Dysphagia, Oropharyngeal, Swallowing Disorder, Validation
Being tested: Turkish Version of Sydney Swallow Questionnaire
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Turkish Version of Sydney Swallow QuestionnaireOther
The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.

Study groups in NCT04465903
Study group	Role	What they receive
Dysphagia patients		The first group consists of 85 dysphagia patients who have at least six months of dysphagia complaints. The participants will given the Turkish version of Sydney Swallow questionnaire (SSQ-T), consisted of 17 questions, eating assessment tool-10 and two scales evaluated with FEES. After the two weeks, 30 participants will given the SSQ-T for sampling. Receives: Other: Turkish Version of Sydney Swallow Questionnaire
Healthy adults		The second group consists of 85 healty participants will given the SSQ-T consists of 17 questions, eating assessment tool-10. Receives: Other: Turkish Version of Sydney Swallow Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

Turkish Version of Sydney Swallow Questionnaire
Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months and healty subjects. The minimum score is 0 and maximum score is 1700. The lower scores mean a normal swallowing function, higher scores mean worst oropharyngeal swallowing functions.
Measured: Baseline
Turkish Version of Sydney Swallow Questionnaire
Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months. The minimum score is 0 and maximum score is 1700. The lower scores mean is a normal swallowing function, higher scores mean is worst oropharyngeal swallowing functions.
Measured: 2 weeks

Secondary outcomes (3)

Eating Assessment Tool
The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.
Measured: Baseline
Penetration and aspiration scale
The scale consists of 8 levels for assessment of penetration and aspiration. The scores are from 0 to 8. Low score is better, higher score is worse.
Measured: Baseline
YALE scale of pharyngeal residue
The scale consists of 5 assessment units for pharyngeal residue. The scores are from 1 to 5. Low score is better, higher score is worse.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 202030 Oct 2020

First posted10 Jul 2020
Study start30 Jul 2020
Primary completion30 Oct 2020
Study completion30 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Dysphagia, OropharyngealStudies of the same condition, open and under way.
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: Other
Time perspective: Prospective
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04465903
Sponsor's protocol ID: 298
Status last verified: Jul 2021
First submitted: 3 Jul 2020
Last updated: 3 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Arenaz Bua B, Bulow M. Validation in Swedish of Sydney swallow questionnaire. BMC Res Notes. 2014 Oct 21;7:742. doi: 10.1186/1756-0500-7-742.
PubMed 25330714
Audag N, Goubau C, Danse E, Vandervelde L, Liistro G, Toussaint M, Reychler G. Validation and Reliability of the French Version of the Sydney Swallow Questionnaire. Dysphagia. 2019 Aug;34(4):556-566. doi: 10.1007/s00455-019-09978-9. Epub 2019 Feb 1.
PubMed 30707281
Dwivedi RC, St Rose S, Chisholm EJ, Georgalas C, Bisase B, Amen F, Kerawala CJ, Clarke PM, Nutting CM, Rhys-Evans PH, Harrington KJ, Kazi R. Evaluation of swallowing by Sydney Swallow Questionnaire (SSQ) in oral and oropharyngeal cancer patients treated with primary surgery. Dysphagia. 2012 Dec;27(4):491-7. doi: 10.1007/s00455-012-9395-z. Epub 2012 Feb 21.
PubMed 22350113
Wallace KL, Middleton S, Cook IJ. Development and validation of a self-report symptom inventory to assess the severity of oral-pharyngeal dysphagia. Gastroenterology. 2000 Apr;118(4):678-87. doi: 10.1016/s0016-5085(00)70137-5.
PubMed 10734019

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire (SSQ-T)
ClinicalTrials.gov ID: NCT04465903
Acronym / sponsor ID: 298
Conditions: Dysphagia, Oropharyngeal, Swallowing Disorder, Validation
Study type: Observational
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
Study start: 30 Jul 2020 (actual)
Primary completion: 30 Oct 2020 (actual)
Study completion: 30 Oct 2020 (actual)
First posted: 10 Jul 2020 (actual)
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.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Dysphagia patients	–	Other: Turkish Version of Sydney Swallow QuestionnaireThe first group consists of 85 dysphagia patients who have at least six months of dysphagia complaints. The participants will given the Turkish version of Sydney Swallow questionnaire (SSQ-T), consisted of 17 questions, eating assessment tool-10 and two scales evaluated with FEES. After the two weeks, 30 participants will given the SSQ-T for sampling.
Healthy adults	–	Other: Turkish Version of Sydney Swallow QuestionnaireThe second group consists of 85 healty participants will given the SSQ-T consists of 17 questions, eating assessment tool-10.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Adults with oropharyngeal dysphagia and healthy adults

Key inclusion criteria (8 listed)

Able to speak, read, understand and write in Turkish
History of dysphagia during 6 months
Age between 18-80 years
Able to speak, read, understand and write in Turkish
Healthy adults

Key exclusion criteria (8 listed)

Mental disorders
Cognitive limitations
Able not to speak, read, understand and write in Turkish
Underwent any surgery last a month
Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy

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
Turkish Version of Sydney Swallow QuestionnaireThe Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.	Other	Dysphagia patients, Healthy adults

Primary outcome

Turkish Version of Sydney Swallow Questionnaire
Time frame: Baseline
Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months and healty subjects. The minimum score is 0 and maximum score is 1700. The lower scores mean a normal swallowing function, higher scores mean worst oropharyngeal swallowing functions.
Turkish Version of Sydney Swallow Questionnaire
Time frame: 2 weeks
Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months. The minimum score is 0 and maximum score is 1700. The lower scores mean is a normal swallowing function, higher scores mean is worst oropharyngeal swallowing functions.

3 secondary outcomes

Eating Assessment Tool
Time frame: Baseline
Penetration and aspiration scale
Time frame: Baseline
YALE scale of pharyngeal residue
Time frame: Baseline

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 3 Aug 2021.
Results publication: PubMed 25330714Arenaz Bua B, Bulow M. Validation in Swedish of Sydney swallow questionnaire. BMC Res Notes. 2014 Oct 21;7:742. doi: 10.1186/1756-0500-7-742.
Results publication: PubMed 30707281Audag N, Goubau C, Danse E, Vandervelde L, Liistro G, Toussaint M, Reychler G. Validation and Reliability of the French Version of the Sydney Swallow Questionnaire. Dysphagia. 2019 Aug;34(4):556-566. doi: 10.1007/s00455-019-09978-9. Epub 2019 Feb 1.
Results publication: PubMed 22350113Dwivedi RC, St Rose S, Chisholm EJ, Georgalas C, Bisase B, Amen F, Kerawala CJ, Clarke PM, Nutting CM, Rhys-Evans PH, Harrington KJ, Kazi R. Evaluation of swallowing by Sydney Swallow Questionnaire (SSQ) in oral and oropharyngeal cancer patients treated with primary surgery. Dysphagia. 2012 Dec;27(4):491-7. doi: 10.1007/s00455-012-9395-z. Epub 2012 Feb 21.
Results publication: PubMed 10734019Wallace KL, Middleton S, Cook IJ. Development and validation of a self-report symptom inventory to assess the severity of oral-pharyngeal dysphagia. Gastroenterology. 2000 Apr;118(4):678-87. doi: 10.1016/s0016-5085(00)70137-5.
Individual participant dataSharing planned: No

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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.

Melis Ece Arkan Ararat, MD principal investigator

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Ugur Uygan, MD principal investigator

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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, Oropharyngeal and Swallowing Disorder, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).

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 8 inclusion and 8 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 3 Aug 2021. 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 Turkey (Türkiye). 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?

Turkish Version of Sydney Swallow Questionnaire (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04465903, which also lists 4 linked publications.

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 3 Aug 2021.