Feasibility study of saliva swallowing frequency measurements using 24-hours ambulatory impedance-pH monitoring in patients with Parkinson*s disease and drooling.

• Conditions: drooling; 10028037

• Registration Number: NL-OMON41751
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

Patients diagnosed with Parkinson's disease or with an atypical parkinsonism irrespective of Hoehn & Yahr stage.
Patients with slight to severe complaints about saliva control or drooling.
Patients who are able to cooperate in the protocol.

Exclusion Criteria

Any medical treatment of drooling causing hyposalivation.
Suspected or confirmed pharyngeal or upper esophageal obstruction.
Severe coagulopathy, outside the therapeutic range when applicable.
Presence of any structural abnormality of the esophagus which theoretically may be associated with an increased risk of side effect or hamper the intubation. These includes peptic strictures, ulcers, tumors, varices or large diverticula.
Cardiac conditions such as a previous episode of bacterial endocarditis, heart valve replacement, implantable cardiac defibilator or pacemaker, or any cardiac condition in which vagal stimulation is poorly tolerated.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Criteria for feasibility: 4 out of 5 patients indicate that operating the data<br /><br>logger is feasible, report no or acceptable burden and no adverse events.<br /><br>Total costs, including time for manual counting of spontaneous swallows during<br /><br>24 hour.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>