Primary objective: to objectively diagnose LPR in patients with hoarseness and/or globus complaints, and a Reflux Symptom Index (RSI) > 13. Secondary objective: To asses the accuracy of the Restech Dx-pH probeTM compared to the dual 24h pH probe
ID
Source
Brief title
Condition
- Other condition
- Oral soft tissue conditions
Synonym
Health condition
Laryngofaryngeale Reflux (LFR)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
During 24 hours:
- mean pH
- percentage of time with pH <4.0/4.5/5.0/5.5/6.0/6.5
- number of pH events <4.0/4.5/5.0/5.5/6.0/6.5.
Secondary outcome
Not applicable.
Background summary
Laryngopharyngeal Reflux (LPR) is the retrograde movement of gastric contents
into the laryngopharynx, which can cause complaints of hoarseness and globus.
Dual probe pH measuring and test treatment with Proton Pump Inhibitors (PPI*S)
have been used as diagnostic tools, however, an objective diagnostic procedure
is missing. Recent studies have described the Restech Dx-pH probeTM, a
minimally invasive oropharyngeal pH measurement probe, as an adequate tool to
measure the pH
Study objective
Primary objective: to objectively diagnose LPR in patients with hoarseness
and/or globus complaints, and a Reflux Symptom Index (RSI) > 13. Secondary
objective: To asses the accuracy of the Restech Dx-pH probeTM compared to the
dual 24h pH probe
Study design
Prospective observational study.
Study burden and risks
Subjects will pay two visits to the hospital: the first for placement of the
probes, the second for removing them. There are minor risks of nose bleeding,
nausea, discomfort in throat and irritation from xylocaine spray and sticky
tape. Two questionnaires have to be filled in, which will take 20 minutes.
Patients with hoarseness and globus with an RSI>13 but without the diagnosis of
LPR are interesting study subjects for determining the pH in the oropharynx.
Jan Tooropstraat 164
1061 AE Amsterdam
Nederland
Jan Tooropstraat 164
1061 AE Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Patients with haorseness and/or globus, RSI>13 (n<=20)
- Patients without hoarseness and globus, RSI>13 (n<=20)
- Subjects without hoarseness and globus, RSI<13 (n<=20)
Exclusion criteria
anatomical abnormalities that can explain hoarseness (eg polyp), functional abnormalities that can explain hoarseness (speech therapy related), malignancies, usages of PPI*s or H2 antagonists, pregnancy or lactating, smoking
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 | NL29923.029.09 |