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OpenTrials
Completed

NCT Number: NCT01889043

Monitoring of Non-invasive Ventilation During Sleep in ALS

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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 criteria

  • Patients < 18 years
  • Patients not willing to start NIV

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
First posted
Jun 28, 2013
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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