Tolerability, Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease

San Donato Group (GSD)

Status: Unknown

Conditions: Motor Neuron Disease; Respiratory Failure; Amyotrophic Lateral Sclerosis

Treatments: Device: Standard NIMV; Device: NIMV with sigh breaths

Study type: Interventional

Funder types: Other

Identifiers

NCT04240925

SIGH_01

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

Standard NIMV protocol with sigh breaths

Experimental group

Treatment:

Device: NIMV with sigh breaths

Standard NIMV protocol without sigh breaths

Active Comparator group

Treatment:

Device: Standard NIMV