ClinicalTrials.Veeva

Menu

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

S

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems