Suspended

Chin-Down Posture vs Thickened Liquid Diet for Aspiration Prevention in Parkinson's Disease and Dementia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Chin-down position

+ Thickened liquid administration

Behavioral
Who is being recruted

Synucleinopathies+21

+ Basal Ganglia Diseases

+ Mental Disorders

From 50 to 95 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)
Last updated: April 24, 2006
Sourced from a government-validated database.Claim as a partner

This study focuses on finding the best way to prevent liquid aspiration and aspiration pneumonia in patients with Parkinson's disease and/or dementia. Liquid aspiration is common in older populations, particularly those dealing with debilitation, dementia, and depression. It can lead to pneumonia, which is a significant cause of death in the US among individuals aged 65 and over. Currently, two methods are used to manage this issue: chin-down posture during swallowing and the use of thickened liquids in the diet. However, there's no clear evidence favoring one method over the other, which is why this research is important. In this Phase III study, participants are randomly assigned to either the chin-down position group or the thickened liquid diet group, based on their swallowing function during a modified barium swallow test. The study will recruit patients over a three-year period, with each patient's participation lasting no more than three months. The study aims to determine which of these two interventions is more effective in preventing aspiration and aspiration pneumonia.

NCT00000362
Principal SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)
Last updated: April 24, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 95 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesMental DisordersBrain DiseasesCentral Nervous System DiseasesDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesInfectionsLung DiseasesMovement DisordersNervous System DiseasesOtorhinolaryngologic DiseasesPharyngeal DiseasesPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsNeurodegenerative DiseasesNeurocognitive DisordersParkinsonian DisordersDeglutition DisordersDementiaParkinson DiseasePneumonia, Aspiration

Criteria

1 inclusion criteria required to participate
Have dementia or Parkinson's disease and are found to aspirate on thin liquid during a set of qualifying swallows

13 exclusion criteria prevent from participating
Are a resident in non-participating nursing home or assisted living environment

Currently have a nasogastric tube

Currently have a tracheotomy

Drink more than 3 alcoholic beverages per day on a regular basis

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Wisconsin at Madison & multiple other U.S. locations

Madison, United StatesOpen University of Wisconsin at Madison & multiple other U.S. locations in Google Maps
SuspendedOne Study Center