NCT04465903

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

July 30, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 3, 2020

Last Update Submit

July 30, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 weeks

Secondary Outcomes (3)

  • Eating Assessment Tool

    Baseline

  • Penetration and aspiration scale

    Baseline

  • YALE scale of pharyngeal residue

    Baseline

Other Outcomes (1)

  • Subject demographics

    Baseline

Study Arms (2)

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.

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.

Other: Turkish Version of Sydney Swallow Questionnaire

Interventions

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

Dysphagia patientsHealthy adults

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with oropharyngeal dysphagia and healthy adults

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Melis Ece Arkan Ararat, MD

    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    PRINCIPAL INVESTIGATOR
  • Ugur Uygan, MD

    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 10, 2020

Study Start

July 30, 2020

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

August 3, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations