Non-Invasive Ventilation in Amyotrophic Lateral Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Fondazione Salvatore Maugeri.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT00560287
First received: November 16, 2007
Last updated: March 26, 2010
Last verified: March 2010
  Purpose

Non-invasive mechanical ventilation (NIV) has been increasingly used as a treatment of chronic hypercapnic respiratory failure. Its use in patients affected by chronic obstructive pulmonary disorders is still controversial, while most of the studies performed in restrictive thoracic disorders (RTD), and in particular in neuromuscular patients, suggested alleviation of the symptoms of chronic hypoventilation in the short term, and in two small studies survival was prolonged.

In the terminal phase of the disease, when the respiratory muscles became weaker it is very likely that the operators need to frequently adjust the level of inspiratory pressure in an attempt to guarantee an adequate tidal volume, so that alveolar hypoventilation may be avoided.

Theoretically the use of a volume assisted ventilation may overpass this problem of frequent variations of the settings, since the provision of a fixed tidal volume may always guarantee and adequate alveolar ventilation.

The primary aims of this multicenter randomized study are to evaluate the clinical efficacy, the patients' tolerance and quality of life and the frequency of changing settings in a group of patients with SLS and initial chronic respiratory failure undergoing long-term NIV with Pressure Support Ventilation or Volume Assisted Ventilation.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Chronic Respiratory Failure
Device: Non invasive ventilation delivered with one of the ventilator specifically designed for NIV and given to the patient by the home care providers
Device: Non invasive ventilation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Role of Non-invasive Ventilation in Amyotrophic Lateral Sclerosis: Volume Versus Pressure Mode

Resource links provided by NLM:


Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:
  • quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • tolerance to NIV [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • number of hours of NIV per day [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • frequency of hospital admission [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • frequency of changing the ventilator settings by the operator. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • diurnal and nocturnal gas exchange [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Pulmonary Function Tests (PFTs). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Study Completion Date: August 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Volume assist non-invasive ventilation
Device: Non invasive ventilation delivered with one of the ventilator specifically designed for NIV and given to the patient by the home care providers
A very recent randomized controlled trial show that in ALS without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life, including sleep quality. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy, like riluzole.
Other Names:
  • Legendaire (Airox)
  • Vivo (Breas)
  • Elisee (Saime)
  • Synchrony (Respironics)
Device: Non invasive ventilation
A very recent randomized controlled trial show that in ALS without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life, including sleep quality. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy, like riluzole.
Other Names:
  • Legendaire (Airox)
  • Vivo (Breas)
  • Elisee (Saime)
  • Synchrony (Respironics)
Active Comparator: 2
Pressure Assist mode
Device: Non invasive ventilation delivered with one of the ventilator specifically designed for NIV and given to the patient by the home care providers
A very recent randomized controlled trial show that in ALS without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life, including sleep quality. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy, like riluzole.
Other Names:
  • Legendaire (Airox)
  • Vivo (Breas)
  • Elisee (Saime)
  • Synchrony (Respironics)
Device: Non invasive ventilation
A very recent randomized controlled trial show that in ALS without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life, including sleep quality. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy, like riluzole.
Other Names:
  • Legendaire (Airox)
  • Vivo (Breas)
  • Elisee (Saime)
  • Synchrony (Respironics)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with the diagnosis of ALS and one of the following signs:

    • Vital Capacity < 50% predicted
    • A Maximal Inspiratory Pressure (MIP) < 60% predicted
    • Polygraphic signs of nocturnal hypoventilation with daytime symptoms.

Exclusion Criteria:

  • Life expectancy>12 months
  • Any comorbidity
  • Acute Respiratory Failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560287

Contacts
Contact: Stefano Nava, MD 0382 592 ext 806 snava@fsm.it
Contact: Franco Fanfulla, MD 0382 592 ext 815 ffanfulla@fsm.it

Locations
Italy
Respiratory Unit FSM Not yet recruiting
Pavia, Italy, 27100
Contact: Stefano Nava, md    0382 592 ext 806    snava@fsm.it   
Contact: Francesco Fanfulla, MD    0382 592 ext 815    ffanfulla@fsm.it   
Principal Investigator: Stefano Nava, MD         
Fondazione S.Maugeri Recruiting
Pavia, Italy, 27100
Contact: Stefano Nava, md    o3825921    snava@fsm.it   
Contact: Stefano Nava, md    03825921    snava@fsm.it   
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Investigators
Principal Investigator: Stefano Nava Fondazione Salvatore Maugeri
Principal Investigator: Stefano Nava, MD Fondazione S.maugeri
  More Information

No publications provided

Responsible Party: Stefano Nava, Fondazione S.Maugerii
ClinicalTrials.gov Identifier: NCT00560287     History of Changes
Other Study ID Numbers: 190H09, 190H09
Study First Received: November 16, 2007
Last Updated: March 26, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Salvatore Maugeri:
Amyotrophic Lateral Sclerosis
Non-invasive ventilation
Chronic Respiratory Failure

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Respiratory Insufficiency
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Respiration Disorders
Respiratory Tract Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on September 30, 2014