Nightime NIV Initiation in Amyotrophic Lateral Sclerosis in an Outpatient Setting

NCT02759003 | Completed

• 1 other identifier: CTS 02/2011
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

In patients with amyotrophic lateral sclerosis (ALS), non-invasive mechanical ventilation (NIV) is usually initiated in an in-hospital regime. The investigators evaluated if NIV initiated in an outpatient setting can be as effective as regards patients' adherence. The investigators also evaluated factors predicting NIV adherence and disease progression.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Adherence as measured by the use of ventilator (hours/month)

  Evaluation after 3 months from the end of NIV initiation trial (T2)

  At 3 months

Secondary Outcomes (5)

• Changes in respiratory function as assessed by spirometry

  At 3 months

• Changes in dyspnea symptoms as assessed by Visual Analogue Scale

  At 3 months

• Patient's questionnaire of satisfaction

  At 20 days

• Changes in respiratory function as assessed by Maximal inspiratory pressure/Maximal expiratory pressure

  At 3 months

• Changes in respiratory function as assessed by blood gas analysis

  At 3 months

Study Arms (2)

inpatients group

ACTIVE COMPARATOR

In-hospital nightime NIV initiation. For the inpatients Group, NIV was initiated in the respiratory wards of the two hospitals and continued during night for a minimum of 4 hours/night. Inpatients had a 24-h availability of health staff care. During the night, they had nurses and physicians available on-hand.

Procedure: Nightime NIV initiation

outpatients group

EXPERIMENTAL

Home nightime NIV initiation. For the outpatients group, diurnal NIV was initiated during a scheduled visit in a hospital dedicated room(at least 4 hours/day of care), the trial proceeded at home during the night with a personal caregiver. A minimum of 4 hours/night was required. No support during the night was provided to these patients.

Procedure: Nightime NIV initiation

Interventions

Nightime NIV initiation PROCEDURE

In-hospital vs home

inpatients group; outpatients group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive patients
• definite ALS diagnosis
• aged \> 18 years
• in clinically stable condition
• referred to the ALS outpatient clinics of the Fondazione Salvatore Maugeri Institute of Lumezzane (Brescia) and the Istituto Don Gnocchi Onlus (Milano), Italy for respiratory functional assessment for the purpose of early initiation of NIV
• no chest infections during the previous 3 months.

You may not qualify if:

• cognitive impairment
• refusal to participate
• severe comorbidities and contraindications to NIV (arrhythmias, cardiac failure, history of pneumothorax)
• distance from hospital \> 40 km, travel problems to attend the outpatient clinic

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Enrica Bertella, MD

  Fondazione Salvatore Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 3, 2016
• Study Start: March 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2014
• Last Updated: May 4, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share