Status:
COMPLETED
Monitoring of Non-invasive Ventilation During Sleep in ALS
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
Non-invasive ventilation (NIV) has already shown to improve survival and quality of life in patients with amyotrophic lateral sclerosis (ALS). Quality of sleep seems already to be impaired in patients...
Eligibility Criteria
Inclusion
- Patients with ALS (according to El Escorial criteria) who are planned to start to use NIV, objectivated by a decreased inspiratory muscle force with a restrictive pulmonary function and
- symptoms of nocturnal alveolar hypoventilation or
- increased daytime arterial carbon dioxide partial pressure (PCO2)(\> 45 mmHg) or
- a ≥ 10 mmHg increase in transcutaneous PCO2 during sleep in comparison to a normal awake supine value
Exclusion
- Patients \< 18 years
- Patients not willing to start NIV
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01889043
Start Date
January 1 2012
Last Update
December 14 2015
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000