- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00537641
Efficacy of Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)
July 2, 2015 updated by: Columbia University
Prevalence and Severity of Nocturnal Oxygenation and Ventilation Failure in Patients With Amyotrophic Lateral Sclerosis Using Noninvasive Ventilation
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.
Study Overview
Status
Completed
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10032
- Eleanor and Lou Gehrig ALS/MDA Center at Columbia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerance of bilevel PAP
Time Frame: Up to 3 months
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The ALS Functional Rating Scale - Revised (ALSFRS-R) will be administered to measure tolerance.
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Up to 3 months
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Score on Epworth Sleepiness Scale
Time Frame: Up to 3 months
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Objective evidence of nocturnal sleep-disordered breathing on the bilevel PAP will be measured.
|
Up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Basner, MD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
September 27, 2007
First Submitted That Met QC Criteria
September 27, 2007
First Posted (Estimate)
October 1, 2007
Study Record Updates
Last Update Posted (Estimate)
July 7, 2015
Last Update Submitted That Met QC Criteria
July 2, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAC2000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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