Trial document




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  DRKS00013903

Trial Description

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Title

Short term effects of nasal high flow therapy on autonomic nervous system function and respiration in patients with neuromuscular diseases

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Numerous neuromuscular disorders (NMD) are characterized not only by weakness of axial and limb muscles but also by respiratory muscle and upper airway involvement. Respiratory muscle weakness first manifests as sleep-disordered breathing (SDB). SDB in neuromuscular disease mainly comprises alveolar hypoventilation but upper airway collapse may also occur because pharyngeal muscle tone is impaired by both neuromuscular weakness and sleep.
Diaphragmatic weakness and myopathy are hallmarks of advanced obstructive pulmonary disease leading to even greater impairment of gas exchange in affected patients.
Non-invasive ventilation (NIV) should be initiated in patients with diaphragm weakness if significant SDB or hypercapnic respiratory failure is present. Indication criteria for NIV include measurement of spiromanometric parameters such as forced vital capacity (FVC), maximum inspiratory pressure (MIP), or sniff nasal inspiratory pressure (SNIP).
Mildly affected patients with an indication for NIV are often characterised by adherence problems although they would profit from it in terms of an early support for their diaphragmatic weakness and shortness of breath as a result of this.
Nasal High Flow (NHF) therapy presents a promising therapy that supplies warm heated humidified air with a high flow rate and hence also produces an intrinsic positive airway pressure.
The use of NHF has not been systematically investigated in patients with NME although NHF has been shown to reduce work of breathing in patients with primary lung diseases.
This study therefore aims to investigate the short term daytime effects of NHF on respiration, autonomic nervous system function and hemodynamics in patients with NIV treated hypoventilation due to NME. The effects of different Flow rates will be compared and effects will also be compared to effects of NIV itself.

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Organizational Data

  •   DRKS00013903
  •   2018/04/04
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  •   yes
  •   Approved
  •   2017-668-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   G12 -  Spinal muscular atrophy and related syndromes
  •   E74 -  Other disorders of carbohydrate metabolism
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Interventions/Observational Groups

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    In the afternoon 12 patients with an ongoing nocturnal NIV (Non-invasive ventilation) therapy for hypoventilation due to a NMD (Numerous neuromuscular disorders) will be attached to a full cardiorespiratory polysomnography in our university sleep lab. Beyond that they will be attached to a non-invasive hemodynamic monitor that continuously measures heart rate, blood pressure (including their variabilities) and bio-impedance based stroke volume. Plus, microneurography of the peroneal nerve will be performed in order to (invasively) measure sympathetic nerve activity.
    After 10 minutes of relaxed tidal breathing and in the awake state patients will (in a randomized order) be exposed to 10 Minutes of NHF (Nasal High Flow) at a flow rate of 20 Liters/min, to 10 Minutes of NHF at a flow rate of 50 Liters/min and 10 Minutes to their NIV therapy. Every of these interventions will be separated from one another by 5 minutes of tidal breathing.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Muscular sympathetic nerve activity [Burst rate/min; Burst rate/100 beats], high frequency component of heart rate variability [%], low frequency component of diastolic blood pressure variability [%]
-> measured at daytime and under the above mentioned interventions

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Secondary Outcome

Heart rate [bpm], systolic blood pressure [mmHG], diastolic blood pressure [mmHG], stroke volume index [L/min/m²], high frequency component of diastolic blood pressure variability[%], low frequency component of heart rate variability [%], respiratory rate [/min], tidal volume [ml], minute ventilation [L/min], oxygen saturation [%], transcutaneous CO2 [mmHG], Borg Dyspnoea Scale [points]
-> measured at daytime and under the above mentioned interventions

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/05/01
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

a. Age > 18 years (no age limit)
b. able to consent
c. proven NMD
d. ongoing nocturnal NIV therapy with a nasal mask for hypoventilation due to a NMD
e. good tolerance of and adherence to the ongoing NIV therapy with minimal nasal mask-related problems/discomfort
f. no vital indication for NIV use at night

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Exclusion Criteria

- other severe internistic pre-existing conditions, especially insulin-dependent diabetes or severe renal impairment
- severe neurological pre-existing conditions such as stroke, especially brainstem infarction
- intake of opioids
- severe psychiatric pre-existing conditions

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Addresses

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    • Department für Neurologie- Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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    • Department of Clinical and Experimental Medicine University of Pisa
    • Mr.  Prof. Dr.  Rosa Maria  Bruno 
    • Ospedale Santa Chiara, Building #8 Via Roma 67
    • 56124  Pisa
    • Italy
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    • Cardiovascular Medicine DivisionFondazione Toscana Gabriele Monasterio
    • Mr.  Dr.  Alberto  Giannoni 
    • via Giuseppe Moruzzi 1
    • 56124  Pisa
    • Italy
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    • Department für Neurologie- Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Mr.  Dr. med.  Jens  Spiesshoefer 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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    • Department für Neurologie- Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Mr.  Dr. med.  Matthias  Boentert 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Department für Neurologie- Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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