Swallowing DisorderNCT06491407
RISK FACTOR ANALYSIS OF CHEWING AND SWALLOWING PERFORMANCE IN GERIATRICS
An observational study of Swallowing Disorder and Chewing Problem, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
Various structural and functional problems in neural, sensory and perceptual, cardiovascular, pulmonary, gastrointestinal, endocrine, and musculoskeletal systems occur in geriatrics not associated with a specific disease. One of the problems observed in geriatrics is chewing and swallowing disorders. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Swallowing Disorder, Chewing Problem, Geriatrics
- What is being tested?
- Chewing and swallowing performance assessment and related factors
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Oct 2024
- How long will I take part?
- 1 Day
- 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 65 to 120 years
- All sexes
- Older adult
Study population: Geriatrics over the age of 65 who come for routine examination for Hacettepe University Hospital Geriatri Clinis will be included in the study.
Who may be able to join
- being voluntary to participation,
- Being over 65 years old,
- Understanding and following simple instructions,
- Being able to walk independently for 4 meters.
Who cannot join
- Having a problem that prevents communication and/or following simple instructions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atılım Uiveristy
Ankara, Incek, 06830
Sena N Begen, +905380929826, sena.begen7@gmail.com
About this study
Official title: ANALYSIS OF FACTORS INFLUENCING CHEWING AND SWALLOWING PERFORMANCE IN GERIATRICS WITHIN THE SCOPE OF INTERNATIONAL CLASSİFİCATION OF FUNCTIONING, DISABILITY, AND HEALTH
Various structural and functional problems in neural, sensory and perceptual, cardiovascular, pulmonary, gastrointestinal, endocrine, and musculoskeletal systems occur in geriatrics not associated with a specific disease. One of the problems observed in geriatrics is chewing and swallowing disorders. Failure to detect changes in chewing and swallowing performance in elderly individuals at an early stage may lead to chewing and swallowing disorders and serious complications in later stages. Therefore, it is necessary to comprehensively and systematically address the possible factors affecting chewing and swallowing performance in geriatric individuals.
The first aim of the study is to analyze the factors affecting chewing and swallowing performance in geriatric individuals within the scope of the International Classification of Functioning, Disability, and Health (ICF). The second aim of the study is to create a dysphagia risk prediction model for geriatric individuals based on the results of the analyses to be conducted.
In the study, the dependent variables, chewing performance, will be evaluated with the Chewing and Swallowing Test of Solids, and swallowing performance will be assessed with the Repetitive Saliva Swallowing Test and Dysphagia Limit. Independent variables affecting chewing and swallowing performance have been considered within the scope of the ICF, and all possible factors determined for both geriatrics and swallowing have been listed, and the evaluation parameters and assessment tools have been decided. The evaluation parameters have been categorized under ICF headings such as personal factors, body structures, body functions, activity and participation, and environmental factors, and the evaluations to be conducted have been divided into two groups: geriatric and physiotherapy evaluations. The geriatric evaluations are part of routine geriatric assessment and do not include any specific evaluation for the study. Physiotherapy evaluations will be applied in a certain order to use time efficiently and will take approximately 35-45 minutes. Through geriatric and physiotherapy evaluations, a holistic assessment of participants within the scope of ICF will be ensured.
- Conditions
- Swallowing Disorder, Chewing Problem, Geriatrics
- Being tested
- Chewing and swallowing performance assessment and related factors
- Keywords
- swallow, chewing, geriatrics, risk factor
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing and swallowing performance assessment and related factorsDiagnostic test
In the study, the dependent variables, chewing performance, will be evaluated with the Chewing and Swallowing Test of Solids, and swallowing performance will be assessed with the Repetitive Saliva Swallowing Test and Dysphagia Limit. Independent variables affecting chewing and swallowing performance have been considered within the scope of the ICF, and all possible factors determined for both geriatrics and swallowing have been listed, and the evaluation parameters and assessment tools have been decided.
| Study group | Role | What they receive |
|---|---|---|
| Geriatrics | >65 years old individuals Receives: Diagnostic Test: Chewing and swallowing performance assessment and related factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chewing performance
Measured: 1 day
Swallowing performance
Measured: 1 day
Secondary outcomes (29)
Deccriptive informations
Measured: 1 day
Fragility Assessment
Measured: 1 day
posture assessment
Measured: 1 day
oral structure assessment
Measured: 1 day
cognitive assessment
Measured: 1 day
emotional status assessment
Measured: 1 day
appetite assessment
Measured: 1 day
sleep assessment
Measured: 1 day
hearing and vision assessment
Measured: 1 day
taste and smell assessment
Measured: 1 day
intraoral sensation assessment
Measured: 1 day
Temporomandibular pain assessment
Measured: 1 day
fonation assessment
Measured: 1 day
articulation assessment
Measured: 1 day
Respiratory assessment
Measured: 1 day
exercise tolerance assessment
Measured: 1 day
Feeding and oral intake assessment
Measured: 1 day
Laryngeopharyngeal reflux assessment
Measured: 1 day
oral health assessment
Measured: 1 day
oral dryness assessment
Measured: 1 day
swallow problems assessment
Measured: 1 day
Temporomandibular joint range of motion
Measured: 1 day
jaw openin force
Measured: 1 day
hand grip
Measured: 1 day
5 repetetion sit to stand test
Measured: 1 day
Timed up and go
Measured: 1 day
basic functional independance assessment
Measured: 1 day
enstrümental functional independance assessment
Measured: 1 day
social support assessment
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Feb 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisorderStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Sena Nur Begen, Hacettepe University
- Investigators
- Selen serel arslan, Prof, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491407
- Sponsor's protocol ID
- SBA 23/421
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANALYSIS OF FACTORS INFLUENCING CHEWING AND SWALLOWING PERFORMANCE IN GERIATRICS WITHIN THE SCOPE OF INTERNATIONAL CLASSİFİCATION OF FUNCTIONING, DISABILITY, AND HEALTH
- ClinicalTrials.gov ID
- NCT06491407
- Acronym / sponsor ID
- SBA 23/421
- Conditions
- Swallowing Disorder, Chewing Problem, Geriatrics
- Keywords
- swallow, chewing, geriatrics, risk factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 9 Jul 2024 (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.
Various structural and functional problems in neural, sensory and perceptual, cardiovascular, pulmonary, gastrointestinal, endocrine, and musculoskeletal systems occur in geriatrics not associated with a specific disease. One of the problems observed in geriatrics is chewing and swallowing disorders. Failure to detect changes in chewing and swallowing performance in elderly individuals at an early stage may lead to chewing and swallowing disorders and serious complications in later stages. Therefore, it is necessary to comprehensively and systematically address the possible factors affecting chewing and swallowing performance in geriatric individuals.
The first aim of the study is to analyze the factors affecting chewing and swallowing performance in geriatric individuals within the scope of the International Classification of Functioning, Disability, and Health (ICF). The second aim of the study is to create a dysphagia risk prediction model for geriatric individuals based on the results of the analyses to be conducted.
In the study, the dependent variables, chewing performance, will be evaluated with the Chewing and Swallowing Test of Solids, and swallowing performance will be assessed with the Repetitive Saliva Swallowing Test and Dysphagia Limit. Independent variables affecting chewing and swallowing performance have been considered within the scope of the ICF, and all possible factors determined for both geriatrics and swallowing have been listed, and the evaluation parameters and assessment tools have been decided. The evaluation parameters have been categorized under ICF headings such as personal factors, body structures, body functions, activity and participation, and environmental factors, and the evaluations to be conducted have been divided into two groups: geriatric and physiotherapy evaluations. The geriatric evaluations are part of routine geriatric assessment and do not include any specific evaluation for the study. Physiotherapy evaluations will be applied in a certain order to use time efficiently and will take approximately 35-45 minutes. Through geriatric and physiotherapy evaluations, a holistic assessment of participants within the scope of ICF will be ensured.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatrics | – | Diagnostic Test: Chewing and swallowing performance assessment and related factors>65 years old individuals |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Geriatrics over the age of 65 who come for routine examination for Hacettepe University Hospital Geriatri Clinis will be included in the study.
Key inclusion criteria (4 listed)
- being voluntary to participation,
- Being over 65 years old,
- Understanding and following simple instructions,
- Being able to walk independently for 4 meters.
Key exclusion criteria (1 listed)
- Having a problem that prevents communication and/or following simple instructions.
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 |
|---|---|---|
| Chewing and swallowing performance assessment and related factorsIn the study, the dependent variables, chewing performance, will be evaluated with the Chewing and Swallowing Test of Solids, and swallowing performance will be assessed with the Repetitive Saliva Swallowing Test and Dysphagia Limit. Independent variables affecting chewing and swallowing performance have been considered within the scope of the ICF, and all possible factors determined for both geriatrics and swallowing have been listed, and the evaluation parameters and assessment tools have been decided. | Diagnostic test | Geriatrics |
Primary outcome
Chewing performance
Time frame: 1 day
Swallowing performance
Time frame: 1 day
29 secondary outcomes
Deccriptive informations
Time frame: 1 day
Fragility Assessment
Time frame: 1 day
posture assessment
Time frame: 1 day
oral structure assessment
Time frame: 1 day
cognitive assessment
Time frame: 1 day
emotional status assessment
Time frame: 1 day
appetite assessment
Time frame: 1 day
sleep assessment
Time frame: 1 day
hearing and vision assessment
Time frame: 1 day
taste and smell assessment
Time frame: 1 day
intraoral sensation assessment
Time frame: 1 day
Temporomandibular pain assessment
Time frame: 1 day
fonation assessment
Time frame: 1 day
articulation assessment
Time frame: 1 day
Respiratory assessment
Time frame: 1 day
exercise tolerance assessment
Time frame: 1 day
Feeding and oral intake assessment
Time frame: 1 day
Laryngeopharyngeal reflux assessment
Time frame: 1 day
oral health assessment
Time frame: 1 day
oral dryness assessment
Time frame: 1 day
swallow problems assessment
Time frame: 1 day
Temporomandibular joint range of motion
Time frame: 1 day
jaw openin force
Time frame: 1 day
hand grip
Time frame: 1 day
5 repetetion sit to stand test
Time frame: 1 day
Timed up and go
Time frame: 1 day
basic functional independance assessment
Time frame: 1 day
enstrümental functional independance assessment
Time frame: 1 day
social support assessment
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- 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.
Selen serel arslan, Prof study director
Hacettepe University
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 Swallowing Disorder and Chewing Problem, run by Atılım University 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sena N begen, MSc (05380929826, sena.begen7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chewing performance (time frame: 1 day). 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?
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 9 Jul 2024.