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Changes in Sensitivity, Taste and Smell in Stroke Patients (5S)

U

University of Giessen

Status

Enrolling

Conditions

Dysphagia
Stroke

Treatments

Diagnostic Test: FEES (flexible endoscopic evaluation of swallowing)
Other: Sensitivity threshold
Diagnostic Test: Taste-/smell-test
Diagnostic Test: Neuropsychological testing

Study type

Observational

Funder types

Other

Identifiers

NCT03240965
GI-149/16

Details and patient eligibility

About

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.

Full 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

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Volunteers:

  • informed consent

Stroke patients:

  • informed consent
  • new supratentorial stroke (<72 hours old) confirmed by CT (computed tomography) or MRI (magnetic resonance imaging)

Exclusion criteria

  • 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 design

200 participants in 3 patient groups

Volunteers <60 years
Description:
Volunteers, who are able to consent to participation in the study, as control.
Treatment:
Diagnostic Test: Taste-/smell-test
Other: Sensitivity threshold
Volunteers >60 years
Description:
Volunteers, who are able to consent to participation in the study, as control.
Treatment:
Diagnostic Test: Taste-/smell-test
Other: Sensitivity threshold
Stroke patients
Description:
Stroke patients with supratentorial stroke, who are able to consent to participation in the study.
Treatment:
Diagnostic Test: Neuropsychological testing
Diagnostic Test: Taste-/smell-test
Other: Sensitivity threshold
Diagnostic Test: FEES (flexible endoscopic evaluation of swallowing)

Trial contacts and locations

1

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Central trial contact

Tobias Braun, M.D.

Data sourced from clinicaltrials.gov

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