Neurogenic DysphagiaNCT03241615
Dysphagia Symptom Severity and Quality of Life
An observational study of Neurogenic Dysphagia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Neurogenic Dysphagia
- What is being tested?
- Dysphagia evaluation
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2017to 8 Sep 2017
- 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 20 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients who have neurogenic dysphagia and willing to participate in the study, being over the age of 20, normal cognitive function (24 points according to the Mini Mental State Examination), and having clinically stable neurological disease will be included.
Who may be able to join
- Willing to participate in the study
- Being over the age of 20
- Normal cognitive function
- Suffering from dysphagia at least one month
Who cannot join
- Being under the age of 20 and above 65 years.
- Abnormal cognitive function
- Clinically unstable neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Dysphagia Symptom Severity and Quality of Life
The aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia.
Read the detailed description
The dysphagia related quality of life and perceived dysphagia symptom severity by patients will be used as a complementary information on oropharyngeal dysphagia. Thus, the aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia.
- Conditions
- Neurogenic Dysphagia
- Being tested
- Dysphagia evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dysphagia evaluationOther
Dysphagia evaluation is performed in a clinical setting by an eating assessment tool. Swallowing related quality of life is also assessed.
| Study group | Role | What they receive |
|---|---|---|
| Neurogenic dysphagia | Patients with neurogenic dysphagia who will willing to participate in the study, being over the age of 18, normal cognitive function ([24 points according to the Mini Mental State Examination), suffering from dysphagia at least one month, and having clinically stable neurological disease will be included. Dysphagia evaluation will be performed. Receives: Other: Dysphagia evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia symptom severity
Dysphagia symptom severity will be determined by an eating assessment tool.
Measured: 1 month
Secondary outcomes (1)
Quality of life assessment
Swallowing related quality of life will be determined by an dysphagia specific quality of life instrument called Swallow Quality of Life.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start8 Aug 2017
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic DysphagiaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELEN SEREL ARSLAN, Hacettepe University
- Investigators
- SELEN SEREL ARSLAN, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241615
- Sponsor's protocol ID
- HACETTEPEUNIVERSITY
- Status last verified
- Jan 2024
- First submitted
- 3 Aug 2017
- Last updated
- 3 Jan 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Dysphagia Symptom Severity and Quality of Life
- ClinicalTrials.gov ID
- NCT03241615
- Acronym / sponsor ID
- HACETTEPEUNIVERSITY
- Conditions
- Neurogenic Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 7 Aug 2017 (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.
The aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia.
Detailed description
The dysphagia related quality of life and perceived dysphagia symptom severity by patients will be used as a complementary information on oropharyngeal dysphagia. Thus, the aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurogenic dysphagia | – | Other: Dysphagia evaluationPatients with neurogenic dysphagia who will willing to participate in the study, being over the age of 18, normal cognitive function ([24 points according to the Mini Mental State Examination), suffering from dysphagia at least one month, and having clinically stable neurological disease will be included. Dysphagia evaluation will be performed. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who have neurogenic dysphagia and willing to participate in the study, being over the age of 20, normal cognitive function (24 points according to the Mini Mental State Examination), and having clinically stable neurological disease will be included.
Key inclusion criteria (4 listed)
- Willing to participate in the study
- Being over the age of 20
- Normal cognitive function
- Suffering from dysphagia at least one month
Key exclusion criteria (3 listed)
- Being under the age of 20 and above 65 years.
- Abnormal cognitive function
- Clinically unstable neurological disease
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 |
|---|---|---|
| Dysphagia evaluationDysphagia evaluation is performed in a clinical setting by an eating assessment tool. Swallowing related quality of life is also assessed. | Other | Neurogenic dysphagia |
Primary outcome
Dysphagia symptom severity
Time frame: 1 month
Dysphagia symptom severity will be determined by an eating assessment tool.
1 secondary outcome
Quality of life assessment
Time frame: 1 month
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 Jan 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 principal investigator
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 Neurogenic Dysphagia, run by Hacettepe 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 3 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 Jan 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?
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?
Dysphagia symptom severity (time frame: 1 month). 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 3 Jan 2024.