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Monitoring of Non-invasive Ventilation During Sleep in ALS

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ClinicalTrials.gov Identifier: NCT01889043
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Dries Testelmans, Universitaire Ziekenhuizen 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.


Condition or disease
Amyotrophic Lateral Sclerosis

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of Non-invasive Ventilation During Sleep in ALS
Study Start Date : January 2012
Actual Primary Completion Date : September 2015





Primary Outcome Measures :
  1. Change in transcutaneous carbon dioxide and respiratory events [ Time Frame: 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.

  2. Change in patient-ventilator asynchronies [ Time Frame: 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 :
  1. Impact of NIV on sympatho-vagal balance [ Time Frame: Day 1 and at 1,3,6,9 and 12 months ]
  2. changes in quality of life by patient reported outcomes [ Time Frame: Day 1 and at 1,3,6,9 and 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Amyotrophic lateral sclerosis patients, which are followed at the Neuromuscular Reference Centre UZ Leuven, in need for NIV treatment
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889043


Locations
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Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Dries Testelmans, MD,PhD UZ Leuven
Study Director: Bertien Buyse, MD, PhD UZ Leuven
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Responsible Party: Dr. Dries Testelmans, MD, PhD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01889043    
Other Study ID Numbers: S53536
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015
Keywords provided by Dr. Dries Testelmans, Universitaire Ziekenhuizen Leuven:
Amyotrophic Lateral Sclerosis
Noninvasive Ventilation
Polysomnography
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases