Efficacy of Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)
Completed
Conditions studied: Amyotrophic Lateral Sclerosis, Motor Neuron Disease
In brief
This study will test the hypothesis that noninvasive ventilation (NIV) as prescribed in current medical practice for use in amyotrophic Lateral Sclerosis (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.
Key facts
- Study ID
- NCT00537641
- Run by
- Columbia University
- People needed
- 25
- Starts
- 2007-05-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2015-07-07
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Eleanor and Lou Gehrig ALS/MDA Center at Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
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