Amyotrophic Lateral SclerosisNCT00537446
Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis
A study testing noninvasive positive pressure ventilation in people with Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Columbia University at 1 site in United States.
Trial summary
Amyotrophic Lateral Sclerosis (ALS), or "Lou Gehrig's Disease", is a fatal disorder that causes progressive degeneration and weakening of the muscles of breathing, leading to breathing insufficiency and eventually breathing failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
- What is being tested?
- noninvasive positive pressure ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of amyotrophic lateral sclerosis
- clinical indication to start noninvasive ventilation (forced vital capacity < 50% predicted or signs/symptoms of respiratory insufficiency)
- age 18 to 80 years old
Who cannot join
- prior institution of NIPPV
- inability to safely use NIPPV
- indications for tracheostomy assisted ventilation because of inability to clear secretions from the airway
- inability or unwillingness to perform pulmonary function testing
- presence of advanced dementia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eleanor and Lou Gehrig ALS/MDA Center at Columbia University
New York, New York, 10032
About this study
Official title: Effect of Noninvasive Positive Pressure Ventilation on Pulmonary Function Testing in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), or "Lou Gehrig's Disease", is a fatal disorder that causes progressive degeneration and weakening of the muscles of breathing, leading to breathing insufficiency and eventually breathing failure. This breathing insufficiency is commonly treated with a breathing assistance device, known as noninvasive positive pressure ventilation (NIPPV). While generally well tolerated and accepted, it is not clear whether or to what extent NIPPV in fact helps breathing function: some data suggest that NIPPV preserves breathing function over time, whereas other data suggest that it actually causes breathing function to decline more quickly. No studies have shown what the acute effect of NIPPV is on breathing muscle function in ALS patients.
This study will test the hypothesis that the acute use of NIPPV, at pressure levels that are in common clinical use, will cause measurable changes in tests of breathing function, compared to baseline and to lower levels of NIPPV. We expect that the results of this study will help to clarify whether and to what extent NIPPV assists respiratory muscle function in patients with ALS.
- Being tested
- noninvasive positive pressure ventilation
- Keywords
- noninvasive ventilation
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive positive pressure ventilationDevice
Also called "BiPAP" (Respironics), variable positive airway pressure (VPAP) (ResMed), bilevel positive airway pressure, noninvasive ventilation
Each subject will undergo 2 hours of high-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 12 cm H2O and an expiratory positive airway pressure of 3 cm H2O.
noninvasive positive pressure ventilationDevice
Also called BiPAP (Respironics), VPAP (ResMed), bilevel positive airway pressure, noninvasive ventilation
Each subject will undergo 2 hours of low-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 6 cm H2O and an expiratory positive airway pressure of 3 cm H2O.
| Study group | Role | What they receive |
|---|---|---|
| High-level ventilation | Active comparator | Each subject will spend 2 hours receiving high-level noninvasive ventilation. Receives: Device: noninvasive positive pressure ventilation |
| Low-level ventilation | Active comparator | Each subject will receive 2 hours of low-level noninvasive positive pressure ventilation. Receives: Device: noninvasive positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Pulmonary Function and Respiratory Muscle Pressure Testing
Measured: 5 hours
Difference in Gas Exchange
Measured: 5 hours
Difference in Subjective Dyspnea Between Baseline and the Two Different Ventilator Modes
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert C. Basner, Columbia University
- Investigators
- Robert C Basner, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537446
- Sponsor's protocol ID
- AAAC7394
- Status last verified
- Nov 2020
- First submitted
- 27 Sep 2007
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Noninvasive Positive Pressure Ventilation on Pulmonary Function Testing in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT00537446
- Acronym / sponsor ID
- AAAC7394
- Keywords
- noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Oct 2007 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Amyotrophic Lateral Sclerosis (ALS), or "Lou Gehrig's Disease", is a fatal disorder that causes progressive degeneration and weakening of the muscles of breathing, leading to breathing insufficiency and eventually breathing failure. This breathing insufficiency is commonly treated with a breathing assistance device, known as noninvasive positive pressure ventilation (NIPPV). While generally well tolerated and accepted, it is not clear whether or to what extent NIPPV in fact helps breathing function: some data suggest that NIPPV preserves breathing function over time, whereas other data suggest that it actually causes breathing function to decline more quickly. No studies have shown what the acute effect of NIPPV is on breathing muscle function in ALS patients.
This study will test the hypothesis that the acute use of NIPPV, at pressure levels that are in common clinical use, will cause measurable changes in tests of breathing function, compared to baseline and to lower levels of NIPPV. We expect that the results of this study will help to clarify whether and to what extent NIPPV assists respiratory muscle function in patients with ALS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-level ventilation | Active comparator | Device: noninvasive positive pressure ventilationEach subject will spend 2 hours receiving high-level noninvasive ventilation. |
| Low-level ventilation | Active comparator | Device: noninvasive positive pressure ventilationEach subject will receive 2 hours of low-level noninvasive positive pressure ventilation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of amyotrophic lateral sclerosis
- clinical indication to start noninvasive ventilation (forced vital capacity < 50% predicted or signs/symptoms of respiratory insufficiency)
- age 18 to 80 years old
Key exclusion criteria (5 listed)
- prior institution of NIPPV
- inability to safely use NIPPV
- indications for tracheostomy assisted ventilation because of inability to clear secretions from the airway
- inability or unwillingness to perform pulmonary function testing
- presence of advanced dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noninvasive positive pressure ventilationAlso: "BiPAP" (Respironics), variable positive airway pressure (VPAP) (ResMed), bilevel positive airway pressure, noninvasive ventilationEach subject will undergo 2 hours of high-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 12 cm H2O and an expiratory positive airway pressure of 3 cm H2O. | Device | High-level ventilation |
| noninvasive positive pressure ventilationAlso: BiPAP (Respironics), VPAP (ResMed), bilevel positive airway pressure, noninvasive ventilationEach subject will undergo 2 hours of low-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 6 cm H2O and an expiratory positive airway pressure of 3 cm H2O. | Device | Low-level ventilation |
Primary outcome
Difference in Pulmonary Function and Respiratory Muscle Pressure Testing
Time frame: 5 hours
Difference in Gas Exchange
Time frame: 5 hours
Difference in Subjective Dyspnea Between Baseline and the Two Different Ventilator Modes
Time frame: 5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C Basner, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive positive pressure ventilation in people with Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Pulmonary Function and Respiratory Muscle Pressure Testing (time frame: 5 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.