Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 10, 2006 | ||||||||
| Last Updated Date | November 8, 2007 | ||||||||
| Start Date ICMJE | April 2002 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Decline in forced vital capacity | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00386464 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement | ||||||||
| Official Title ICMJE | Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement | ||||||||
| Brief Summary | Non-invasive ventilation or BiPAP®, which is a form of breathing support delivered through a facemask, is a successful treatment for the respiratory complications of amyotrophic lateral sclerosis (ALS). It has been shown to prolong survival, improve quality of life, and improve cognitive function. It is widely used among patients with ALS who have advanced breathing difficulties. It is not known whether there is benefit to using non-invasive ventilation earlier in the disease course. There is evidence that non-invasive ventilation may slow down the decline in breathing function. If this were true then it would make sense to start non-invasive ventilation use earlier than the current clinically accepted practices. The purpose of this study is to determine whether using non-invasive ventilation early in the course of disease can slow the decline in breathing function. Patients remain in the study for 6 months and are asked to make 7 clinic visits during which time they will undergo pulmonary function tests and complete questionnaires. |
||||||||
| Detailed Description | This is a randomized, crossover trial for patient with ALS and mild respiratory involvement. Patients with forced vital capacity above 60% of the predicted value can join. Patients will be assigned to either start using non-invasive ventilation at night or continue their usual care. After three months, patients will switch over to the other treatment group. For example, a patient who was initially assigned to continue their usual care would begin using non-invasive ventilation after three months. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
||||||||
| Condition ICMJE | Amyotrophic Lateral Sclerosis | ||||||||
| Intervention ICMJE | Device: noninvasive positive pressure ventilation | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Completion Date | September 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00386464 | ||||||||
| Other Study ID Numbers ICMJE | HL 67887-03 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Johns Hopkins University | ||||||||
| Verification Date | April 2007 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||