To assess the feasibility and burden of the 24-hAIpHM to precisely measure saliva swallowing frequency during everyday life in PD patients.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
NA
Background summary
A quarter of patients with Parkinson*s disease (PD) suffer from involuntary
loss of saliva or drooling, which is a disabling and still undertreated
symptom. Precise measurement of saliva swallowing frequency (SSF) related to
the drooling events is essential to better understand the pathophysiology of
drooling and to evaluate and explain the effects of (new) behavioral treatment
approaches. SSF should be measured in everyday life to catch any change in SSF
before and during drooling events at home. Non-invasive measurements of SSF are
either limited in time or location or are still interfered with other upper
airway sounds or body movements. However, 24-hours ambulatory impedance-pH
monitoring (24-hAIpHM), a common gastroenterological measurement is a suitable
instrument for SSF registration, but its feasibility and burden for the
registration of SSF in PD patients with drooling had not been studied yet.
Study objective
To assess the feasibility and burden of the 24-hAIpHM to precisely measure
saliva swallowing frequency during everyday life in PD patients.
Study design
Observational study.
Study burden and risks
24-hAIpHM is an invasive, but common and low risk measurement. The burden is
reported to be low, but it is important to know whether this is also true for
PD patients. The extra burden is coming to the Radboudumc twice and completing
a questionnaire once. The future benefit is the possibilty of having more
treatment options for drooling.
Reinier Postlaan 2
Nijmegen 6525 GC
NL
Reinier Postlaan 2
Nijmegen 6525 GC
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52490.091.15 |