Tolerability, Safety and Efficacy of Sigh During Non-invasive Mechanical Ventilation in Patients With Motor Neuron Disease- A Pilot Study

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:

NCT04240925

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