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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03816098
Other study ID # 07-XD-080
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 11, 2019
Est. completion date December 31, 2019

Study information

Verified date January 2019
Source Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this research was to examine the accuracy of translated Chinese version of Swallowing Dysphagia Questionnaire and to evaluate the prevalence of dysphagia and its clinical manifestation in patients over 65 years old.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- (1) age over 65 years old; (2) does not use enteral tube feeding; (3) no serious mental or cognitive conditions; no aphasia

Exclusion Criteria:

- (1) age under 65; (2) use enteral tube feeding; (3) subjects with serious mental or cognitive conditions or aphasia (4) Allergy to barium sulfate suspension

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary Swallowing Disturbance Questionnaire Chinese version of Swallowing Dysphagia Questionnaire consists of 15 questions regarding oral and pharyngeal stage of dysphagia. Subjects are asked to fill out the questionnaire concerning current state and during the past year using a 4-point scale. At the baseline
Primary Videofluroscopy Swallowing Study (VFSS) VFSS studies are conducted using 4 different consistencies: thin liquid, nectar-thick liquid, puree, and cookie. Subjects are asked to take 2 trials for each consistency to assess if any oral or pharyngeal dysphagia occurs. At the baseline
Secondary Clinical water test Each subject takes 3 trials of 3cc-water using a dropper. Then sequential water drinking is assessed (about 60-70 ml). We assess: coughing, choking, voice changes. At least one symptom means dysphagia. At the baseline
Secondary Mini-Mental State Examination (MMSE) Mini-Mental State Examination was used to identify subjects' cognitive state.The following four cut-off levels should be employed to classify the severity of cognitive impairment: no cognitive impairment=24-30; mild cognitive impairment=19-23; moderate cognitive impairment=10-18; and severe cognitive impairment<9. At the baseline
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