Efficacy of Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)

This study has been completed.
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00537641
First received: September 27, 2007
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

Amyotrophic Lateral Sclerosis (ALS), also known as "Lou Gehrig's Disease", is a fatal disorder that causes breathing failure due to progressive weakness of the muscles of breathing. Breathing assist devices known as noninvasive ventilation (NIV) are offered to ALS patients when their breathing function worsens. These devices deliver breathing assistance via a mask on the nose or nose and mouth, and are thought to be particularly important to be used during sleep, when breathing often becomes more shallow and irregular. However, although these devices have become the standard of therapy in ALS patients once their lung function worsens, it remains unclear how effective these devices actually are when a patient is sleeping, partly because of the practical difficulties in applying the device properly and keeping it applied throughout the sleep period, and partly because they are most commonly prescribed without objective evidence regarding how much breathing support the patient needs as the disease progresses and the breathing muscles weaken further.

This study will test the hypothesis that NIV as prescribed in current medical practice for use in ALS patients fails to deliver adequate breathing support over a night of use in the patient's home. ALS patients who come to the ALS Center for their routine 3 month follow up exam and are currently using NIV will be asked to complete questionnaires regarding their quality of sleep, quality of life and general level of function, and to undergo a home sleep study, using a safe, comfortable and reliable breathing monitoring system during a night of sleep. If the questionnaires or the sleep study show failure of the breathing device, the investigators will work with the patient to fix the problem and then offer a second study to make sure that the changes were helpful. The results of this study may help to develop subsequent studies and to improve the guidelines used for care of ALS patients.


Condition
Amyotrophic Lateral Sclerosis
Motor Neuron Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Severity of Nocturnal Oxygenation and Ventilation Failure in Patients With Amyotrophic Lateral Sclerosis Using Noninvasive Ventilation

Resource links provided by NLM:


Further study details as provided by Columbia University:

Enrollment: 25
Study Start Date: May 2007
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with ALS who are using nocturnal noninvasive ventilation to treat respiratory insufficiency will be screened for eligibility as below.

Criteria

Inclusion Criteria:

  • clinical diagnosis of amyotrophic lateral sclerosis (El Escorial criteria)
  • age 18 to 18 years old
  • using nocturnal noninvasive ventilation to treat respiratory insufficiency at least 4 hours per night, for at least 4 nights per week

Exclusion Criteria:

  • inability to safely use NIPPV because of bulbar dysfunction
  • indications for tracheostomy assisted ventilation due to inability to clear secretions from the airway
  • presence of comorbid conditions with a life expectancy < 6 months
  • presence of advanced dementia
  • unwillingness to follow up at the Eleanor and Lou Gehrig ALS/MDA Center at Columbia University on a regular basis
  • previously diagnosed obstructive sleep apnea
  • residence outside the New York metropolitan area.
  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: NCT00537641

Locations
United States, New York
Eleanor and Lou Gehrig ALS/MDA Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Robert Basner, MD Columbia University
  More Information

No publications provided

Responsible Party: Robert C. Basner, Columbia University Medical Center
ClinicalTrials.gov Identifier: NCT00537641     History of Changes
Other Study ID Numbers: AAAC2000
Study First Received: September 27, 2007
Last Updated: April 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
noninvasive ventilation

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

ClinicalTrials.gov processed this record on July 23, 2014