NCT04240925

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Ospedale San Raffaele · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Motor Neuron Disease
• Respiratory Failure
• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DEVICE	NIMV with sigh breaths	Sigh breaths: Maximal Inspiratory pressure (IPAPmax) increased of at least 25% ( ≥ 125%) with a frequency of at least 1/200 breaths. The sigh breaths will be delivered as part of the standard NIMV protocol
DEVICE	Standard NIMV	Will be treated by standard NIMV with no sigh

Timeline

• Start date: 2018-05-25
• Primary completion: 2022-04-30
• Completion: 2022-12-31
• First posted: 2020-01-27
• Last updated: 2022-03-16

Locations

1 site across 1 country: Italy