NCT04889170

Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease

Completed Last updated 14 November 2023

What this trial tests

trial testing Intervention in Parkinson Disease in 180 participants. Completed in 1 December 2022.

Timeline

1 December 2020

Primary endpoint
1 December 2022

1 December 2022

Quick facts

Lead sponsor	Neurological Rehabilitation Hospital Rosenhügel
Status	Completed
Study type	OBSERVATIONAL
Enrollment	180
Start date	1 December 2020
Primary completion	1 December 2022
Estimated completion	1 December 2022
Sites	1 location across Austria

Drugs / interventions tested

• Intervention

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Dysphagia — all drugs for Dysphagia →

Sponsor

Neurological Rehabilitation Hospital Rosenhügel

Who can join

Adults 18 to 90, any sex, with Parkinson Disease or Dysphagia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

In idiopathic Parkinson's disease, 50% of patients develop in the course of the disease a dysphagia and aspiration pneumonia is the leading cause of death in all parkinsonian syndromes . Dysphagia can negatively impact on the course of Parkinson's disease due to complications such as aspiration pneumonia, malnutrition, inadequate drug action, it causes a deterioration in quality of life and leads to an increase in health care costs of more than 10% Therefore, it is very important to detect subclinical dysphagia in time in Parkinson's disease and to initiate a targeted swallowing therapy. In the Neurological Rehabilitation Center Rosenhügel, patients with Parkinson's disease participate in the Parkinson rehabilitation pathway during their rehabilitation program. A part of the Parkinson rehabilitation pathway is the dysphagia pathway. It includes a clinical swallowing examination, an instrumental assessment of swallowing, performed by a fiberoptic endoscopic evaluation of swallowing (FEES) and a dysphagia training. Because of the serious clinical consequences of dysphagia, the investigators decided to further evaluate the prevalence of subclinical and clinical dysphagia in Parkinson's disease and to assess the efficacy of the NRZ dysphagia pathway. Our goal is to detect and classify all Parkinson's disease patients with dysphagia and to prevent the complications of dysphagia by an early therapeutic intervention.

Objectives Primary objective: Evaluation of prevalence of dysphagia in Parkinson's disease Secondary objective: Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia through vocal training or dysphagia training Methods A prospective cohort study will be conducted for 24 months. All patients with the diagnosis of a Parkinson's disease, who are treated as inpatients in the Neurological Rehabilitation Center Rosenhügel from 5/2020 till 5/2022 and have signed an informed consent form will be enrolled in the study. The patients will be examined for dysphagia by a clinical swallowing examination, by a FEES and by measuring the swallowing related quality of life before and after dysphagia training.

Intervention A dysphagia training, which consists of a biofeedback therapy and a swallow training or a voice training. The intervention lasts 3 weeks, by extended stay it lasts 5 or 7 weeks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.