Standardized Dysphagia Diet in Clinical Evaluation of Swallowing Function

NCT05634980 | Unknown

• 1 other identifier: 202105007RINB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Diet modification has been a vital component in the management of dysphagia. The lingual manipulation of bolus, pharyngeal propulsion, and initiation of swallowing reflex are all affected by the texture of bolus. However, there is a limited literature and consensus regarding how to apply different food consistency in the swallowing function evaluation of dysphagic patients. Recently, International Dysphagia Diet Standardization Initiative (IDDSI) has provided a universal standard of food consistency. The present study aims to evaluate the accuracy of clinical swallowing evaluation using IDDSI standardized food in dysphagic patients, in an attempt to establish protocols of clinical evaluation and diet selection in dysphagic patients.

Conditions

Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization

Outcome Measures

Primary Outcomes (1)

• Penetration aspiration scale (PAS)

  Penetration aspiration scale

  Day 1

Interventions

FEES OTHER

Fiberoptic Endoscopic Evaluation of Swallowing (FEES) exam

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a swallowing disorder

You may qualify if:

• Patients aged 20 years or older with a swallowing disorder on the Functional Oral Intake Scale (FOIS) of 1-6.

You may not qualify if:

• Unconscious, unable to communicate via gestures or words and cooperate with commands.
• Acutely infected or requiring respirator use.
• The oropharyngeal structure is abnormal and cannot be examined by endoscopy.
• Presence of tracheostomy tube

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Fees and Charges

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Central Study Contacts

Ming-Yen Hsiao

CONTACT

+886223123456; myferrant@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: August 3, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-11

Locations

TW (1)