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"New Perspectives of Adaptation to NIV in ALS" | Clinical Trials | Clareo Health

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"New Perspectives of Adaptation to NIV in ALS"

"New Perspectives of Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS)"

NCT02537132•Fondazione Don Carlo Gnocchi Onlus

Summary

The purpose of this study is to demonstrate that the adaptation to the Non Invasive Ventilation (NIV) at home is not worse when compared with an adaptation performed in inpatient settings.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•ALS diagnosis according to the criteria of El Escorial;
•Clinical indication to NIV (nocturnal hypoventilation and respiratory muscle weakness confirmed according to the criteria normally accepted);
•No respiratory infection within 3 months
•Severe disability (ALS-FRS \<31);
•Age \> 18 years;
•The voluntary participation to the Study.

Exclusion Criteria

•\-- Previous episodes of pneumothorax;
•Comorbid cardiac and / or renal important
•Severe cognitive impairment;
•Refusal of the patient at the time of Informed Consent.

Locations (2)

Michele Vitacca

Lumezzane, Brescia, Italy

Paolo Banfi

Milan, Italy

Key Dates

Start Date

January 1, 2015

Primary Completion Date

April 1, 2016

Completion Date

January 1, 2018

Last Updated

August 2, 2018

Enrollment

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

Adaptation and training to Non Invasive Ventilation (NIV)

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 2, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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"New Perspectives of Adaptation to NIV in ALS"

Inclusion Criteria

Exclusion Criteria

Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

A Study to Evaluate the Tolerability, Safety and Efficacy of VGN-R13 in Patients with ALS

Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis