Study Purpose:
Non-invasive mechanical ventilation (NIMV) is the recommended standard of care as initial therapy for patients with motor neuron disease (MND) with deterioration of the respiratory function.SIGH_01 study is aimed at investigating the tolerability, safety profile and efficacy of sigh breaths during non-invasive mechanical ventilation in patients with MND in comparison to the standard ventilation support protocol.
Study Status:
Not recruiting
Disease:
Motor Neuron Disease , Respiratory Failure , Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
NIMV with sigh breaths, Standard NIMV
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
nilo riva, MD,PhD, Ospedale San Raffaele
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Study Sponsor:
Ospedale San Raffaele
Estimated Enrollment:
44
Estimated Study Start Date:
05 / 25 / 2018
Estimated Study Completion Date:
12 / 31 / 2022
Posting Last Modified Date:
03 / 16 / 2022
Date Study Added to neals.org:
01 / 27 / 2020
Minimum Age:
N/A
Maximum Age:
N/A
Inclusion Criteria:- Willing and able to give informed consent
- MND diagnosis according to El-Escorial criteria
- Non-invasive ventilation indications in accordance with the international guidelines
Exclusion Criteria:
- Inability to adhere to study visit schedule or lack of reliable caretaker
- Presence of dementia
- History of arrhythmia, heart failure or pneumothorax
Ospedale San Raffaele
Milano 20132
Italy