Inhalation Valve
Completed
- Conditions
- medisch hulpmiddel voor mensen na laryngectomietracheostoma
- Registration Number
- NL-OMON33932
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference in speech power (maximum phonation time multiplied with the<br /><br>maximum loudness) of both types of speechvalves. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The difference in maximum amount of words using one breathe while reading a<br /><br>standardised text.</p><br>