The aim of the study is to generate a validated questionnaire to measure dysphagia in the three different stages of Huntington's disease.
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To validate the questionnaire videofluoroscopic examination will be used.
In order to measure convergent construct validity the questionnaire will be
compared with the Swallowing Disturbance Questionnaire (SDQ), and the Eating
Assessment Tool (EAT-10). Partners or relatives will be asked to fill in the
questionnaires simultaneously with the patients.
Secondary outcome
na
Background summary
Most patients with Huntington's disease suffer from dysphagia. Dysphagia has
influence on the quality of life for the patients, but can also have physical
consequences, like pneumonia. Research demonstrates that more than a half of
the patients die from pneumonia due to dysphagia. It is therefore very
important to find out when dysphagia in Huntington's disease starts, and how it
progresses. In this study a scale will be created, especially for Huntington's
disease patients, which measures the severity of the dysphagia in the disease.
When it is known when dysphagia in Huntington's disease starts, and how it
progresses, intervention studies can be set up. Patients can also be better
treated because of the more precise knowledge on dysphagia in Huntington's
disease.
Study objective
The aim of the study is to generate a validated questionnaire to measure
dysphagia in the three different stages of Huntington's disease.
Study design
The study will be divided into two phases:
phase 1
- generate a sample of questions related to Huntington's disease and dysphagia
at the level of disability
- investigate intelligibility of the questions and the response options
phase 2
- test-retest the questionnaire in the three clinical stages of Huntington's
disease
- item reduction and scale construction
- validation of the questionnaire
Study burden and risks
It is stated that participation in this study the risks can be considered
negligible, and the burden minimal. The average effective dose for
videofluoroscopy is 1 mSv per test. To compare: videography of the thorax gives
a dose of 0.09 mSv, and a scan of the abdomen gives a dose of 10 mSv. A year
dose as result of background radiation in the Netherlands is 2 mSv.
Videofluoroscopy is not stressful, patients will not receive any tubes.
Albinusdreef P.O. Box 9600
2300 RC Leiden
NL
Albinusdreef P.O. Box 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Huntington's disease patients, CAG over 36 repeats.
Exclusion criteria
Other diseases or conditions that may influence swallowing.
Design
Recruitment
metc-ldd@lumc.nl
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 | NL39192.058.12 |