Registry of Endpoints and Validated Experiences in ALS
Completed
- Conditions
- Amyotrophic lateral sclerosis1002830210029317
- Registration Number
- NL-OMON49001
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
1. Age > 18 years
2. Diagnosis of ALS according to the El Escorial criteria
3. Kings Stage 2,3 and 4A
4. Ability to give informed consent
5. Ability to complete respiratory function measurement as defined by the
ability to generate consistent scores on FVC (2 valid scores within 10%).
6. Ability to correspond remotely by email /text message independently or with
the assistance of a carer.
Exclusion Criteria
1. Diagnosis of another respiratory condition requiring current active
management (e.g. Asthma, COPD, bronchiectasis, lung cancer etc).
2. Use of NIV at time of enrolment (King Stage 4B).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Rate of respiratory and functional decline, mortality and RTIs. </p><br>
- Secondary Outcome Measures
Name Time Method <p>• Examine the relationships between rates of decline in respiratory function<br /><br>measures and prognosis / life expectancy / NIV initiation.<br /><br>• Examine the relationship between respiratory tract infection morbidity and<br /><br>respiratory function.<br /><br>• Examine the relationship between respiratory function and respiratory<br /><br>impairment symptoms.<br /><br>• Correlate rates of decline in respiratory function measures and overall<br /><br>functional decline using the ALS functional rating scale (ALSFRS-R).<br /><br>• Examine the respiratory tract infection morbidity rates.<br /><br>• Examine the predictive value across a range of respiratory function<br /><br>constructs to predict carbon dioxide pressure (PCO2).<br /><br>• Explore the potential relationships between other demographic<br /><br>characteristics, baseline variables, and outcome measures as defined above</p><br>