Dysphagia5SNCT03240965
Changes in Sensitivity, Taste and Smell in Stroke Patients
An observational study of Dysphagia and Stroke, run by University of Giessen at 1 site in Germany.
Trial summary
This study evaluates changes in swallowing using endoscopic swallowing studies and measuring of pharyngeal sensitivity, taste and smell in stroke patients. Younger (<60 years) and older (>60 years) volunteers will serve as control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- FEES (flexible endoscopic evaluation of swallowing), Sensitivity threshold and Taste-/smell-test
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2017to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients are recruited in a university hospital's department of neurology. Volunteers >60years are recruited in a trauma surgery ward at the same university hospital. Volunteers <60 are recruited without specified characteristics (aside from in-/exclusion criteria).
Who may be able to join
- Volunteers:
- informed consent
- Stroke patients:
- informed consent
- new supratentorial stroke (<72 hours old) confirmed by CT (computed tomography) or MRI (magnetic resonance imaging)
Who cannot join
- pre-existing stroke oder dysphagia
- extensive white matter lesions in CT- or MRI-scan
- allergies to odorous substances or flavoring
- contraindications for FEES (flexible endoscopic evaluation of swallowing), CT or MRI (stroke patients only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Gießen
Giessen, Hesse, 35392
Tobias Braun, M.D., +49 641 985 ext. 56827, tobias.braun@neuro.med.uni-giessen.de
About this study
Official title: Changes in Sensitivity of Swallowing-relevant Structures, Taste and Smell in Stroke Patients
This study evaluates changes in swallowing using endoscopic swallowing studies and measuring of pharyngeal sensitivity, taste and smell in stroke patients. Younger (<60 years) and older (>60 years) volunteers will serve as control.
Read the detailed description
Stroke is the second leading cause of death. At least 50% of stroke patients develop dysphagia, leading to aspiration pneumonia, which is the main cause of death in stroke [2].
It is assumed that normal sensitivity is vital for aspiration-free swallowing and for the triggering of the swallowing reflex.
Ali et al. demonstrated aspiration-free swallowing in healthy volunteers who underwent local anaesthesia of oral and pharyngeal structures [1]. Power et al. showed a reduced sensitivity of pharyngeal structures in stroke patients prone to aspiration [3].
By combining measuring sensitivity and flexible endoscopic swallowing studies, this study further investigates the role of sensitivity in swallowing Neuropsychological deficits of swallowing, such as swallowing apraxia or buccal hemineglect, is assessed by neuropsychological testing.
Additionally, there is no systematic research investigating the change in smell and taste in correlation with changes in stroke patients
- Being tested
- FEES (flexible endoscopic evaluation of swallowing), Sensitivity threshold, Taste-/smell-test, Neuropsychological testing
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEES (flexible endoscopic evaluation of swallowing)Diagnostic test
Endoscopical swallowing study in stroke patients only
Sensitivity thresholdOther
Determining sensitivity threshold using a pudendal electrode
Taste-/smell-testDiagnostic test
Taste-/smell-test
Neuropsychological testingDiagnostic test
Neuropsychological testing for neglect, agnosia
| Study group | Role | What they receive |
|---|---|---|
| Volunteers <60 years | Volunteers, who are able to consent to participation in the study, as control. Receives: Other: Sensitivity threshold; Diagnostic Test: Taste-/smell-test | |
| Volunteers >60 years | Volunteers, who are able to consent to participation in the study, as control. Receives: Other: Sensitivity threshold; Diagnostic Test: Taste-/smell-test | |
| Stroke patients | Stroke patients with supratentorial stroke, who are able to consent to participation in the study. Receives: Diagnostic Test: FEES (flexible endoscopic evaluation of swallowing); Other: Sensitivity threshold; Diagnostic Test: Taste-/smell-test; Diagnostic Test: Neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia
Changes found in endoscopic swallowing study :
Presence and severity of dysphagia (measured with Rosenbek's Penetration/Aspiration-scale)
Measured: 96 hours after initial symptoms
Secondary outcomes (4)
Neuropsychological deficits
Agnosia, neglect
Measured: 96 hours after initial symptoms
Lesion site
Side, vascular territory, swallowing relevant structures
Measured: 96 hours after initial symptoms
Sensitivity
Sensitivity of faucial pillar region
Measured: 96 hours after initial symptoms
Taste/Smell
Smell-/Taste-score
Measured: 96 hours after initial symptoms
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 start1 Oct 2017
- Primary completionFeb 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Braun, University of Giessen
- Investigators
- Tobias Braun, M.D., Principal investigator, University Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240965
- Sponsor's protocol ID
- GI-149/16
- Acronym
- 5S
- Status last verified
- Nov 2023
- First submitted
- 28 Jul 2017
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ali GN, Laundl TM, Wallace KL, Shaw DW, Decarle DJ, Cook IJ. Influence of mucosal receptors on deglutitive regulation of pharyngeal and upper esophageal sphincter function. Am J Physiol. 1994 Oct;267(4 Pt 1):G644-9. doi: 10.1152/ajpgi.1994.267.4.G644.
PubMed 7943330Kidd D, Lawson J, Nesbitt R, MacMahon J. Aspiration in acute stroke: a clinical study with videofluoroscopy. Q J Med. 1993 Dec;86(12):825-9.
PubMed 8108539Power ML, Hamdy S, Singh S, Tyrrell PJ, Turnbull I, Thompson DG. Deglutitive laryngeal closure in stroke patients. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):141-6. doi: 10.1136/jnnp.2006.101857. Epub 2006 Sep 29.
PubMed 17012336Braun T, Doerr JM, Peters L, Viard M, Reuter I, Prosiegel M, Weber S, Yeniguen M, Tschernatsch M, Gerriets T, Juenemann M, Huttner HB, Hamzic S. Age-related changes in oral sensitivity, taste and smell. Sci Rep. 2022 Jan 27;12(1):1533. doi: 10.1038/s41598-022-05201-2.
PubMed 35087097Braun T, Hamzic S, Doerr JM, Peters L, Viard M, Reuter I, Prosiegel M, Weber S, Yenigun M, Tschernatsch M, Gerriets T, Juenemann M. Facilitation of oral sensitivity by electrical stimulation of the faucial pillars. Sci Rep. 2021 May 24;11(1):10762. doi: 10.1038/s41598-021-90262-y.
PubMed 34031508
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Sensitivity of Swallowing-relevant Structures, Taste and Smell in Stroke Patients
- ClinicalTrials.gov ID
- NCT03240965
- Acronym / sponsor ID
- 5S / GI-149/16
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- 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.
This study evaluates changes in swallowing using endoscopic swallowing studies and measuring of pharyngeal sensitivity, taste and smell in stroke patients. Younger (<60 years) and older (>60 years) volunteers will serve as control.
Detailed description
Stroke is the second leading cause of death. At least 50% of stroke patients develop dysphagia, leading to aspiration pneumonia, which is the main cause of death in stroke [2].
It is assumed that normal sensitivity is vital for aspiration-free swallowing and for the triggering of the swallowing reflex.
Ali et al. demonstrated aspiration-free swallowing in healthy volunteers who underwent local anaesthesia of oral and pharyngeal structures [1]. Power et al. showed a reduced sensitivity of pharyngeal structures in stroke patients prone to aspiration [3].
By combining measuring sensitivity and flexible endoscopic swallowing studies, this study further investigates the role of sensitivity in swallowing Neuropsychological deficits of swallowing, such as swallowing apraxia or buccal hemineglect, is assessed by neuropsychological testing.
Additionally, there is no systematic research investigating the change in smell and taste in correlation with changes in stroke patients
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Volunteers <60 years | – | Other: Sensitivity threshold, Diagnostic Test: Taste-/smell-testVolunteers, who are able to consent to participation in the study, as control. |
| Volunteers >60 years | – | Other: Sensitivity threshold, Diagnostic Test: Taste-/smell-testVolunteers, who are able to consent to participation in the study, as control. |
| Stroke patients | – | Diagnostic Test: FEES (flexible endoscopic evaluation of swallowing), Other: Sensitivity threshold, Diagnostic Test: Taste-/smell-test, Diagnostic Test: Neuropsychological testingStroke patients with supratentorial stroke, who are able to consent to participation in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients are recruited in a university hospital's department of neurology. Volunteers >60years are recruited in a trauma surgery ward at the same university hospital. Volunteers <60 are recruited without specified characteristics (aside from in-/exclusion criteria).
Key inclusion criteria (5 listed)
- informed consent
- informed consent
- new supratentorial stroke (<72 hours old) confirmed by CT (computed tomography) or MRI (magnetic resonance imaging)
Key exclusion criteria (4 listed)
- pre-existing stroke oder dysphagia
- extensive white matter lesions in CT- or MRI-scan
- allergies to odorous substances or flavoring
- contraindications for FEES (flexible endoscopic evaluation of swallowing), CT or MRI (stroke patients only)
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 |
|---|---|---|
| FEES (flexible endoscopic evaluation of swallowing)Endoscopical swallowing study in stroke patients only | Diagnostic test | Stroke patients |
| Sensitivity thresholdDetermining sensitivity threshold using a pudendal electrode | Other | Stroke patients, Volunteers <60 years, Volunteers >60 years |
| Taste-/smell-testTaste-/smell-test | Diagnostic test | Stroke patients, Volunteers <60 years, Volunteers >60 years |
| Neuropsychological testingNeuropsychological testing for neglect, agnosia | Diagnostic test | Stroke patients |
Primary outcome
Dysphagia
Time frame: 96 hours after initial symptoms
Changes found in endoscopic swallowing study : Presence and severity of dysphagia (measured with Rosenbek's Penetration/Aspiration-scale)
4 secondary outcomes
Neuropsychological deficits
Time frame: 96 hours after initial symptoms
Lesion site
Time frame: 96 hours after initial symptoms
Sensitivity
Time frame: 96 hours after initial symptoms
Taste/Smell
Time frame: 96 hours after initial symptoms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 7943330Ali GN, Laundl TM, Wallace KL, Shaw DW, Decarle DJ, Cook IJ. Influence of mucosal receptors on deglutitive regulation of pharyngeal and upper esophageal sphincter function. Am J Physiol. 1994 Oct;267(4 Pt 1):G644-9. doi: 10.1152/ajpgi.1994.267.4.G644.
- Background: PubMed 8108539Kidd D, Lawson J, Nesbitt R, MacMahon J. Aspiration in acute stroke: a clinical study with videofluoroscopy. Q J Med. 1993 Dec;86(12):825-9.
- Background: PubMed 17012336Power ML, Hamdy S, Singh S, Tyrrell PJ, Turnbull I, Thompson DG. Deglutitive laryngeal closure in stroke patients. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):141-6. doi: 10.1136/jnnp.2006.101857. Epub 2006 Sep 29.
- Derived from this study: PubMed 35087097Braun T, Doerr JM, Peters L, Viard M, Reuter I, Prosiegel M, Weber S, Yeniguen M, Tschernatsch M, Gerriets T, Juenemann M, Huttner HB, Hamzic S. Age-related changes in oral sensitivity, taste and smell. Sci Rep. 2022 Jan 27;12(1):1533. doi: 10.1038/s41598-022-05201-2.
- Derived from this study: PubMed 34031508Braun T, Hamzic S, Doerr JM, Peters L, Viard M, Reuter I, Prosiegel M, Weber S, Yenigun M, Tschernatsch M, Gerriets T, Juenemann M. Facilitation of oral sensitivity by electrical stimulation of the faucial pillars. Sci Rep. 2021 May 24;11(1):10762. doi: 10.1038/s41598-021-90262-y.
- Individual participant dataSharing planned: Undecided
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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.
Tobias Braun, M.D. principal investigator
University Giessen
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 and Stroke, run by University of Giessen at 1 site in Germany.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Dec 2023. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Braun, M.D. (+49(0)-641-985 ext. 56827, tobias.braun@neuro.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia (time frame: 96 hours after initial symptoms). 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 NCT03240965, which also lists 5 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 1 Dec 2023.