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Sponsored by: |
Columbia University |
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Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00537641 |
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 |
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Amyotrophic Lateral Sclerosis Motor Neuron Disease |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Prevalence and Severity of Nocturnal Oxygenation and Ventilation Failure in Patients With Amyotrophic Lateral Sclerosis Using Noninvasive Ventilation |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with ALS who are using nocturnal noninvasive ventilation to treat respiratory insufficiency will be screened for eligibility as below.
Inclusion Criteria:
Exclusion Criteria:
Contact: Amy Atkeson, MD | 212-305-7591 | ad720@columbia.edu |
Contact: Robert Basner, MD | 212-305-7591 |
United States, New York | |
Eleanor and Lou Gehrig ALS/MDA Center at Columbia University | Recruiting |
New York, New York, United States, 10032 | |
Sub-Investigator: Amy Atkeson, MD |
Principal Investigator: | Robert Basner, MD | Columbia University |
Responsible Party: | Columbia University Medical Center ( Robert C. Basner ) |
Study ID Numbers: | AAAC-2000 |
Study First Received: | September 27, 2007 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00537641 History of Changes |
Health Authority: | United States: Institutional Review Board |
noninvasive ventilation |
Lou Gehrig's Disease Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Central Nervous System Diseases |
Sclerosis Neurodegenerative Diseases Degenerative Motor System Disease Motor Neuron Disease |
Pathologic Processes Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Nervous System Diseases |
Central Nervous System Diseases Sclerosis Neurodegenerative Diseases Motor Neuron Disease |