Monitoring of Non-invasive Ventilation During Sleep in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Monitoring of Non-invasive Ventilation During Sleep in ALS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889043
• Other study ID #: S53536
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: December 11, 2015
• Start date: January 2012

Study information

• Verified date: December 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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 with preserved diaphragmatic dysfunction. Until now, only few research has been performed on the quality of sleep in patients with ALS when using NIV, and these data are mainly based on patient reported outcomes.Further on, only very little research has been done on patient-ventilator interaction.

Our study would like to perform research on quality of sleep before and after NIV use by using full polysomnography with incorporation of transcutaneous carbon dioxide measurement and built-in ventilator software.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

1. symptoms of nocturnal alveolar hypoventilation or

2. increased daytime arterial carbon dioxide partial pressure (PCO2)(> 45 mmHg) or

3. a = 10 mmHg increase in transcutaneous PCO2 during sleep in comparison to a normal awake supine value

Exclusion Criteria:

• Patients < 18 years

• Patients not willing to start NIV

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in transcutaneous carbon dioxide and respiratory events	Search for an optimal titration protocol. Aim is to reduce transcutaneous carbon dioxide (CO2) below 55 mmHg and to reduce central and obstructive respiratory events to a minimum. This will be assessed by performance of a nocturnal measurement of transcutaneous CO2 and full polysomnography at eacht time point.	At day 2, 3 and 4 and at 1, 3, 6, 9 and 12 months	No
Primary	Change in patient-ventilator asynchronies	The following asynchronies will be evaluated: auto-triggering, double triggering, ineffective effort, prolonged insufflation. The impact of leaks will also be evaluated.Data will be reported as events/hour of sleep. This will be assessed by full polysomnography at each time point.	Day 4 and at 1,3,6,9 and 12 months	No
Secondary	Impact of NIV on sympatho-vagal balance		Day 1 and at 1,3,6,9 and 12 months	No
Secondary	changes in quality of life by patient reported outcomes		Day 1 and at 1,3,6,9 and 12 months	No