Monitoring of Non-invasive Ventilation During Sleep in ALS

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT01889043
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-28
• Primary Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-11
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in transcutaneous carbon dioxide and respiratory events	At day 2, 3 and 4 and at 1, 3, 6, 9 and 12 months	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.
Change in patient-ventilator asynchronies	Day 4 and at 1,3,6,9 and 12 months	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.

Secondary Outcome Measures

Name	Time	Method
changes in quality of life by patient reported outcomes	Day 1 and at 1,3,6,9 and 12 months
Impact of NIV on sympatho-vagal balance	Day 1 and at 1,3,6,9 and 12 months

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium