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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41751
Enrollment
5
Registered
2015-06-03
Start date
2015-05-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

drooling

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Criteria for feasibility: 4 out of 5 patients indicate that operating the data logger is feasible, report no or acceptable burden and no adverse events. Total costs, including time for manual counting of spontaneous swallows during 24 hour.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)