The overall aim of the study is to evaluate the difference in speech performance of a new hands-free speech valve as compared to the currently most used (Atos) exhalation speech valve.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
medisch hulpmiddel voor mensen na laryngectomie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in speech power (maximum phonation time multiplied with the
maximum loudness) of both types of speechvalves.
Secondary outcome
The difference in maximum amount of words using one breathe while reading a
standardised text.
Background summary
A number of the patients with laryngeal cancer have to be treated with a total
laryngectomy. As part of the rehabilitation, a shunt valve can be placed in a
tracheostoma between the trachea and the oesophagus. If the patient wants to
speak, the stoma is closed with a finger or thumb to force expired air through
the shunt valve into the oesophagus. Soft tissue at the top of the oesophagus
starts to vibrate and functions as new vocal folds.
Some of these patients use a tracheostoma valve (TV) on their stoma. This
enables them to speak without using their hands.
The department of biomedical engineering of the faculty of medicine at the
University of Groningen, has developed a new TV. This new TV is automatically
closed by inhalation, in contrast to the currently used exhalation valves
(Atos). By this means the patient should be able to save more air for
phonation. Expectations 1) patients are able to speak longer using the new TV.
2) patients can speak louder using the TV.
Study objective
The overall aim of the study is to evaluate the difference in speech
performance of a new hands-free speech valve as compared to the currently most
used (Atos) exhalation speech valve.
Study design
The pilot study is a RCT with a crossover design.
Intervention
New developed hands free Inhalation Valve made by the Department of BioMedical
Engineering (BME) of the University Medical Center Groningen, The Netherlands.
Study burden and risks
About 60 minutes of their time is required in addition to them already being
present for their routine check-up or appointment. The burden on the patient is
minimal. The tests are non-invasive and there are no extra risk factors
expected in participating in the study. No patients have ever tried the IV and
it is possible that they can benefit from the use of the IV. A better
tracheostoma valve can mean a more comfortable voice production.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Post-laryngectomees aged between 45 and 70 that have been using a TE shunt prosthesis for their phonation for at least six months.
Exclusion criteria
Excluded are patients with ulceration, infection or metastasis around or in the stoma or severe respiratory problems. Generally excluded are patients in such bad health that cooperation with this study is too heavy a burden.
Design
Recruitment
Medical products/devices used
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 | NL23245.042.09 |